Notice of Special Interest (NOSI): Developing and Testing Multilevel Physical Activity Interventions to Improve Health and Well-Being
Notice Number:
NOT-OD-21-087

Key Dates

Release Date:

April 6, 2021

First Available Due Date:
June 05, 2021
Expiration Date:
February 16, 2024

Related Announcements

NOT-CA-21-065 - Notice of Change to NOT-OD-21-087

NOT-AA-21-013 - Notice of NIAAA Participation in NOT-OD-21-087

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

PAR-19-275- Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-18-592 - Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed)

PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

PAR-21-033 NCI's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

PAR-19-309 - Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)

PAR-20-052 - NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)

PAR-19-135 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)

PAR-18-480 - NICHD Research Project Grant (R01 Clinical Trial Required)

PAR-18-481 - NICHD Small Grant Program (R03 Clinical Trial Optional)

PAR-20-042 - NCMRR Early Career Research Award (Clinical Trial Optional)

PAR-19-133 - Academic Research Enhancement Award for Undergraduate- Focused Institutions (R15 Clinical Trial Required)

PAR-21-107 - NIDCD Early Career Research (ECR) Award (R21 Clinical Trial Optional)

PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required)

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

RFA-MH-20-506 - Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R34 Clinical Trial Required)

RFA-MH-20-505 - Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional)

PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

PAR-21-134 - Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)

PAR-21-135 - Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)

PAR-19-070 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

PAR-18-877 - Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)

PAR-20-150 - NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)

PAR-20-214 - Research to Improve Native American Health (R21 Clinical Trials Optional)

PAR-20-238 - Intervention Research to Improve Native American Health (R01 Clinical Trial Optional)

PA-18-849 - Prevention Research in Mid-Life Adults (R01 Clinical Trial Optional)

PA-18-850 - Prevention Research in Mid-Life Adults (R21 Clinical Trial Optional)

PAR-19-256 - Limited Competition: Modular Budget Research Project Grant for NIH Nurse Scientist Scholars (R01 Clinical Trial Optional)

NOT-OD-21-085 - Notice of Information Reissuance of PAR-18-307

NOT-OD-21-086 - Notice of Information Reissuance of PAR-18-324

NOT-OD-21-120 - Notice of Technical Assistance Webinar for NOT-OD-21-087, Developing and Testing Multilevel Physical Activity Interventions to Improve Health and Well-Being NOSI from the under related assignment.

NOT-OD-24-021 - Notice of Special Interest (NOSI): Developing and Testing Multilevel Physical Activity Interventions to Improve Health and Well-Being

Issued by

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Purpose

The Office of Disease Prevention and participating ICOs are issuing this Notice to highlight our interest in encouraging highly innovative and promising translational research to improve our understanding of how to increase and maintain health-enhancing physical activity using multi-level interventions in a wide range of population groups across the lifespan (e.g., including racial and ethnic minorities, children, older adults, persons with medical/behavioral health conditions, and persons with disabilities). This includes efficacy, effectiveness and dissemination and implementation studies. It also includes support for pilot, exploratory, or developmental work in preparation for full-scale, fully powered efficacy studies, preliminary feasibility studies, as well as expanded feasibility work for a discrete, specified, circumscribed project that is based on well-established theory, existing data and evidence-based interventions.

Background:

Physical activity is an important health behavior that is associated with numerous health conditions and outcomes. The evidence reviewed for the 2018 edition of the Physical Activity Guidelines for Americans indicates physical activity fosters normal growth and development, can make people feel better, function better, sleep better, and reduces the risk of a large number of chronic diseases. The evidence about the health benefits of regular physical activity is well established. Yet, according to the guidelines and the Healthy People 2030 overview on physical activity, only 1 in 4 adults and 1 in 5 adolescents in the United States meet physical activity guidelines for aerobic and muscle-strengthening activities. The U.S. Global Burden of Disease Collaborators (2018) note physical inactivity as a leading risk factor associated with morbidity and mortality in the United States. The Center for Disease Control's Community Preventive Services Task Force issued a number of insufficient evidence statements and positive recommendations that highlight future research needs for physical activity programs that target schools, families, workplaces, and built environments.

Reductions in daily physical activity caused by poor sleep quality, stay-at-home mandates issued for public health emergencies, or improper nutrition, for example, highlight the need for physical activity research focused on both intervention development and intervention testing that bridges basic and applied science. Furthermore, insights from basic research can potentially be used to identify more effective, efficient, and sustainable interventions for improving overall physical activity-related behavior and health changes. Current evidence indicates that integrated physical activity interventions aimed at several levels, consistent with socio-ecological models, may be effective to get people moving, both at the individual and community level. Higher chances of sustaining healthy physical activity-related behavior occur when an ecological approach is integrated in the prevention strategy.

Socioecological models and frameworks, including the NIMHD Minority Health and Health Disparities Research Framework and the NIA Health Disparities Research Framework, offer a systematic approach by which population-specific determinants for overall physical health and well-being can be identified, measured, operationalized, and analyzed. Implementation research frameworks, such as Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health Services (PARiHS); or Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) have been used to describe, guide, or inform key implementation processes and determinants. Rigorous research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge, Type III hybrid effectiveness, etc.), also offer tremendous benefit in multi-level intervention studies. The NIH Stage Model offers a framework for considering when an intervention is ready for widespread implementation and emphasizes attention to the principles or mechanisms of action at any level of analysis that account for an intervention’s effects.

Research Objectives:

This Notice encourages translational research aimed at developing or testing multi-level physical activity interventions to improve health and well-being. For the purpose of this NOSI, multi-level is defined as having an effect on at least two levels of influence. At minimum, the proposed study must:

  1. include physical activity as one of the primary outcomes,
  2. inform development of or test an intervention or program that acts on at least two socioecological domains or levels; and
  3. demonstrate high potential for scalability and sustainability.

For example, an intervention might focus on incorporating components of a healthy diet in combination with increasing physical activity at a school or workplace. Likewise, an intervention might include technology-based challenges at the interpersonal level, as well as the initiation/strengthening of joint-use agreements for community members to use recreation facilities at the public policy level. A different intervention might focus on methods for enhancing motivation at the intrapersonal level and creating online social support groups for physical activity at the interpersonal level. Policy or built environmental intervention across worksites at an organizational level may be paired with individually targeted intervention components to promote physical activity. Studies proposing to address multi-level interventions can include experimental designs or natural experiments created by changes in policy. Intervention settings can include, but are not limited to, healthcare settings, worksites, households, schools, green space, parks and recreation centers, other community organizations and settings, or entire communities.

This NOSI seeks research for all developmental stages, across the lifespan, and in diverse populations, particularly those at high risk for sedentary behavior, those at high risk for disease conditions associated with inactivity, and those at risk for food insecurity. Populations of interest include, but are not limited to:

  • Sedentary or inactive individuals or groups of all ages
  • Persons or groups at high risk for conditions associated with inactivity (e.g., overweight, obesity, etc.)
  • Person with a disease (e.g., malnutrition, cancer, age-related diseases, etc.) or condition (e.g., serious mental illness, nicotine dependence, etc.) that might be improved by physical activity
  • NIH-designated populations who experience health disparities in the United States (which include racial and ethnic minority groups (Blacks or African Americans, Hispanics or Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders), less privileged socioeconomic status, sexual and gender minorities, and underserved rural populations
  • Eligible participants of major food and nutrition assistance programs (e.g., Supplemental Nutrition Assistance Program, Child Nutrition Programs and Women Infants and Children Program, etc.) and other food distribution programs
  • Eligible participants of social service or community programs, such as child welfare and justice programs
  • Persons with physical, developmental, or intellectual disabilities
  • Underserved populations at higher risk for conditions associated with inactivity
  • Populations in communities with a high burden of health disparities (e.g., geographic regions like the Mississippi Delta or Appalachia, rural and urban neighborhoods, etc.) with low physical activity levels

This NOSI encourages feasibility and pilot research, as well as efficacy and effectiveness research on new or adapted interventions. To maximize comparisons across datasets or studies, and facilitate data integration and collaboration, researchers funded through this NOSI are encouraged to use the following resource:

  • Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, human-subject studies should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).

Investigators who conduct original and innovative basic biomedical, social, behavioral, clinical, or population-based research directed toward eliminating health disparities are invited to apply to this NOSI. Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that research programs will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity).

Study Design

Design, Analysis, and Sample Size Considerations for Studies to Evaluate Interventions:

Investigators seeking to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study design in which groups subjected to the intervention are compared to groups that are exposed to an appropriate comparison condition. The comparison condition should be justified based on the state-of-the-science for the intervention and the nature of the research question. Designs that might be proposed for studies that randomize groups or deliver interventions to groups include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster- randomized trials, multiple baseline designs, and another quasi-experimental designs. Whenever participants are assigned in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states), or participants receive some part of their intervention in a group or cluster, and observations on individual participants are analyzed for between-group effects, special methods are required for analysis and sample size. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative. The following types of projects would generally not be appropriate and may be deemed non-responsive:

  • Projects that do not include physical activity as one of the primary outcomes
  • Projects that do not consider more than one level of analysis (individual, interpersonal, institutional, community, and policy)

Investigators must carefully review the specific research interests of NIH Institutes and Centers that are participating in this NOSI.

IC Specific Application and Submission Information:

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

  • PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
  • PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
  • PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
  • PA-18-592 - Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed)
  • PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
  • PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
  • PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

All instructions in the SF424 (R&R) Application Guide and the listed funding opportunity announcements must be followed, with the following additions:

  • For funding consideration, applicants must include NOT-OD-21-087 in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

National Cancer Institute (NCI)

The National Cancer Institute is interested in applications of multi-level physical activity interventions that have implications for outcomes across the cancer continuum and that have the potential for adoption, implementation, and sustainability in real-world settings.

The proposed intervention must include physical activity change as a primary endpoint and be designed to test statistically significant differences in the outcome based on the intervention over a one or more-year intervention period. Secondary outcomes of interest include: implementation feasibility information, prevention of secondary conditions (such as obesity, decrement in skeletal muscle strength and functioning, aerobic fitness, or decline in bone health) and related biomarkers of health, amelioration of persistent post-cancer treatment conditions or toxicities affecting physical and cognitive function. Where inclusion of obesity as secondary outcome occurs, the intervention should principally aim to improve physical activity or reduce sedentary behavior and include rationale for health benefit independent of weight loss.

NCI’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

June 5, 2021

R01

PAR-21-033 NCI's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

June 5, 2021

R21

PAR-19-309 - Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)

June 16, 2021

R03

PAR-20-052 - NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)

June 24, 2021

R15

PAR-19-135 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)

June 25, 2021

R15

PAR-19-133 - Academic Research Enhancement Award for Undergraduate- Focused Institutions (R15 - Clinical Trial Required)

June 25, 2021

National Center for Complementary and Integrative Health (NCCIH):

The National Center for Complementary and Integrative Health has a strategic research goal to study complementary health approaches to promote health and wellness across the lifespan in diverse populations. NCCIH's strategic plan is available at: https://www.nccih.nih.gov/about/strategic-plans-and-reports. For this NOSI, NCCIH is particularly interested in applications that propose to incorporate a complementary approach as part of the multi-level intervention for promoting physical activity. Complementary approaches include those with physical and/or psychological therapeutic inputs, often called mind and body approaches (e.g., acupuncture, yoga, tai chi, qi gong, meditation, hypnosis, music therapy, art therapy, spinal or chiropractic manipulation, and massage). For more details on NCCIH’s approach to funding clinical trials, including a description of our available FOA s, please see https://nccih.nih.gov/grants/funding/clinicaltrials. Investigators interested in developing or testing a new multi-level intervention may use an available funding opportunity listed on our clinical trials funding webpage (https://nccih.nih.gov/grants/funding/clinicaltrials) to respond to this NOSI. Investigators interested in developing or testing dissemination or implementation research for a multi-level intervention incorporating a complementary approach should use one of the FOAs listed below. Investigators are strongly encouraged to discuss their research plans with NCCIH program staff prior to submitting their application

NCCIH’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

R21

PAR-19-275 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

June 16, 2021

National Institute on Aging (NIA)

A strategic research goal (https://www.nia.nih.gov/about/aging-strategic-directions-research) of NIA is to develop effective interventions to maintain health, well-being, and function and prevent or reduce the burden of age-related diseases, disorders, and disabilities, including neurodegenerative diseases such as Alzheimer’s disease and Alzheimer’s disease related dementias, and other age-related chronic conditions. This includes research on interventions to promote adherence to behavioral regimens aimed at promoting healthy aging, such as physical activity. NIA applications submitted in response to this NOSI are strongly encouraged to articulate their research aims using the NIH Stage Model framework and to identify goals consistent with the Stages I through IV of the translational intervention development pipeline. Applicants are also encouraged to apply approaches and tools for assessment of behavioral mechanisms developed under the NIH Common Fund’s Science of Behavior Change (SOBC) Program (https://commonfund.nih.gov/behaviorchange).

NIA’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

R21

PAR-19-275 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

June 16, 2021

R01

PAR-19-070 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

July 9, 2021

R01

PAR-18-877 - Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)

June 5, 2021

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

NIAMS is interested in projects testing the adoption, implementation, and sustainability, in real-world settings, of multi-level physical activity interventions that have implications for the primary and secondary prevention of arthritis and musculoskeletal diseases.

NIAMS’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-19-274 Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

NICHD supports research that addresses healthy development and growth of infants and children, improves outcomes related to fertility and pregnancy, and promotes the health, productivity, independence, and well-being of people with disabilities across the lifespan. NICHD is particularly interested in projects that establish the effectiveness and scalability of interventions that promote physical activity shown to improve health outcomes in the foregoing populations, sustain participation in physical activity, and considers context, including the needs, motivations, sustainability, and barriers to participation. NICHD encourages applications that propose interventions across multiple levels of the socioecological model, including individual and community contexts, and leverage unique insights from members of the populations of interest as research team members or in paid advisory roles.

NICHD’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-18-480 - NICHD Research Project Grant (R01 Clinical Trial Required)

June 5, 2020

R03

PAR-18-481 - NICHD Small Grant Program (R03 Clinical Trial Optional)

July 16, 2021

R03

PAR-20-042 - NCMRR Early Career Research Award (Clinical Trial Optional)

March 30, 2022

R15

PAR-19-135 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)

June 25, 2021

R15

PAR-19-133 - Academic Research Enhancement Award for Undergraduate- Focused Institutions (R15 Clinical Trial Required)

June 25, 2021

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIDCD supports research and research training in hearing, balance, smell, taste, voice, speech, and language. Applications exploring the influence across the lifespan of multilevel physical activity interventions within the mission areas of NIDCD are encouraged. Studies emphasizing recruitment of underrepresented minorities will be prioritized.

NIDCD’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R21

PAR-21-107 - NIDCD Early Career Research (ECR) Award (R21 Clinical Trial Optional)

June 24, 2021

National Institute of Mental Health (NIMH):

NIMH encourages research that addresses Institute priorities and is aligned with these recommended areas for domestic and global mental health research. HIV-related applications to NIMH will not be considered responsive. Appropriate topics include, but are not limited to studies mentioned below:

Intervention and Services Research

For research on the effectiveness of interventions or services, NIMH supports studies that employ an experimental therapeutics approach, whereby clinical trials are designed not only to test the intervention effects on mental health and/or physical health outcomes of interest, but also to inform understanding of the intervention’s mechanisms of action. As such, applications that propose to develop and/or test the efficacy/effectiveness of preventive, therapeutic or services interventions must include specification of the intervention target(s)/mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcome. In the case of services interventions, targets/mechanisms might involve mutable service user or provider behaviors, or organizational/system-level factors that are intervened upon in order to improve access, continuity, quality, equity, and/or value of services. Studies adapting existing preventive, therapeutic or services interventions to specifically target certain populations, e.g., by racial or ethnic identity or LGBTQ+ status, should provide a justification for the unique targets to be tested. See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated Funding Opportunity Announcements (FOAs) for NIMH clinical trials research support.

Preventive Interventions

All studies on preventive interventions should include mental health outcomes as a primary outcome.

  • Studies that utilize physical activity interventions to reduce risk for mental health symptoms and disorders across the lifespan.
  • Studies that augment efficacious and/or effective mental health prevention interventions with physical activity interventions to increase effects on mental health outcomes.
  • Research on physical activity preventive interventions that address mental health disparities
  • Research on physical activity interventions with pregnant women to reduce risk for perinatal anxiety and depression.
  • Studies that incorporate strategies to engage and retain individuals in physical activity interventions designed to reduce risk for mental health difficulties.

Treatment Interventions

All studies on treatment interventions should include mental health outcomes as a primary outcome

  • Studies of the role of physical activity interventions in post-acute and maintenance treatment of mood and anxiety disorders.
  • Adaptation of physical activity interventions across the lifespan, e.g. in adolescents and seniors.
  • Studies of the role of anaerobic exercise in the treatment of mental disorders.
  • Studies that address motivational challenges and enhance adherence to the use of physical activity interventions in the treatment of mental disorders.
  • Early stage clinical trials to establish the feasibility and initial efficacy of novel physical activity interventions targeting established, malleable factors of mental disorders. Such trials should follow the NIMH experimental therapeutics approach and utilize the NIMH-specific funding opportunity announcements for clinical trials.
  • Studies that refine identification of mental health relevant targets for effective exercise interventions.

Services Interventions

NIMH encourages services research on practical strategies for preventing and/or reducing the common modifiable health risks that contribute to heart disease, diabetes, cancer, stroke, and pulmonary disease in people with serious mental illness (SMI) and lead to their premature mortality. Research that addresses (1) service delivery strategies for the recognition, management and treatment of common modifiable health risks, which include low physical activity and poor fitness, as well as obesity, smoking, hypertension, metabolic disorder, substance use, and diet, and (2) increasing access to evidence-based interventions that address these health risks in people with SMI, and intervention adaptations that may be needed for effectiveness in people with SMI, is encouraged. This research may focus on adults with SMI and/or children and youth with serious emotional disturbance (SED) and should include physical health as a primary outcome; inclusion of other common modifiable health risks associated with premature mortality in people with SMI as primary or secondary outcomes is encouraged.

Research areas of interest to NIMH include but are not limited to the following:

  • Innovative services interventions to reduce the prevalence and magnitude of common modifiable health risk factors related to shortened lifespan in this population, including low physical activity and poor fitness.
  • Developing and testing practical service delivery interventions with health promotion, lifestyle change and self-management components for people with SMI or SED, to include increasing physical activity and/or fitness, as well as those integrating intervention components to target multiple health risks and/or increase the magnitude of treatment effects.
  • Implementation studies of demonstrated effective service delivery strategies for improving physical health and fitness and reducing other common modifiable health risk factors in people with SMI or SED.
  • Studies on service delivery strategies for improving physical health and fitness and reducing other common health risk factors in people with SMI or SED that are conducted in a community setting that serves as a platform to engage this population, either within or outside of traditional healthcare settings, such as community mental health centers or early psychosis treatment programs.

NIMH’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R34

PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

June 15, 2021

R01 PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required) June 15, 2021

R01

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

June 15, 2021

R34

RFA-MH-20-506 - Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R34 Clinical Trial Required)

July 1, 2021

R01

RFA-MH-20-505 - Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional)

July 1, 2021

R01

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

R21

PAR-19-275 Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

June 16, 2021

R01

PAR-21-132 Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

June 15, 2021

R33

PAR-21-134 Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)

June 15, 2021

R61/R33

PAR-21-135 - Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)

June 15, 2021

National Institute on Minority Health and Health Disparities (NIMHD):

NIMHD is interested in supporting research on multi-level physical activity interventions for health disparity populations that are deliverable and sustainable at settings where these populations live, work, play or receive health care. Intervention design should be based on theories from minority health and health disparities science. Research projects must focus primarily on one or more health disparity population (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). Comparison groups or populations may be included as appropriate for the research questions posed. Settings of interest include but are not limited to low-resourced urban neighborhoods and communities, rural communities, small municipalities, and/or delivered within health care settings for medically underserved, e.g., Federally Qualified Health Centers (FQHCs) or Tribal healthcare centers or with disparity populations within any health care system. NIMHD is interested in interventions that include components that address the neighborhood social environment (e.g., social cohesion, social capital, collective efficacy, community resilience), structural barriers and facilitators (e.g., neighborhood safety, safe paths for walking), or strategies that mitigate against unintended policy level consequences (e.g., displacement of persons with low SES due to gentrification). NIMHD is also interested in novel behavior change strategies that target decision making processes (impulsive/executive decision systems) to follow through with healthy choices under conditions of high stressors (e.g., poverty, discrimination, or financial insecurity), incorporating cultural resiliency and protective factors and culturally tailored interventions and/or technology. For multi-levels and domains of interest refer to the NIMHD Research framework, https://nimhd.nih.gov/about/overview/research-framework.html.

NIMHD’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Activity Code

FOA

First Available Application Due Date

R01

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

R21

PAR-20-150 - NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)

June 16, 2021

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR funds observational, intervention, and translational research that integrates factors at multiple levels to identify their role in health, health improvement and health inequities in the many settings where nurses practice, including homes, schools, clinics, workplaces, and criminal justice facilities. NINR encourages research to improve the health of individuals, families, and populations, translating science in order to maximize the impact of findings on practice and policy. Potential applicants are encouraged to discuss their research plans with the Program Staff in relevant areas.

For this NOSI, NINR is interested in grant applications that include physical activity and/or sedentary behavior as a primary outcome, while also addressing one or more of these areas of interest:

  • Barriers and facilitators at multiple levels: interpersonal, institutional, community, and policy
  • Holistic approaches incorporating other health behaviors to address multiple chronic disease risk factors
  • Social determinants of health and health disparities
  • Progression towards achieving physical activity recommendations
  • Physical activity assessment, measurement error, or pattern analysis
  • Application of technology (e.g., mHealth, virtual/remote interventions, artificial intelligence)

Activity Code

FOA

First Available Application Due Date

R01

PA-18-849 - Prevention Research in Mid-Life Adults (R01 Clinical Trial Optional)

June 5, 2021

R21

PA-18-850 - Prevention Research in Mid-Life Adults (R21 Clinical Trial Optional)

June 16, 2021

R01

PAR-18-877- Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)

June 5, 2021

R01

PAR-19-274- Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

June 5, 2021

R21

PAR-19-275- Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

June 16, 2021

R15

PAR-19-133- Academic Research Enhancement Award for Undergraduate- Focused Institutions (R15 - Clinical Trial Required)

June 25, 2021

R15

PAR-19-135- Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)

June 25, 2021

R01

PAR-19-256 - Limited Competition: Modular Budget Research Project Grant for NIH Nurse Scientist Scholars (R01 Clinical Trial Optional)

October 4, 2021

R21

PAR-20-214 - Research to Improve Native American Health (R21 Clinical Trials Optional)

May 17, 2022

R01

PAR-20-238 - Intervention Research to Improve Native American Health (R01 Clinical Trial Optional)

May 17, 2022

Office of Disease Prevention (ODP):

The Office of Disease Prevention is interested in co-funding applications for multi-level physical activity interventions that have strong implications for disease prevention, promise for broader adoption and use, and that showcase innovative and appropriate design, measurement, and analysis methods. The ODP Strategic Plan FY2019-2023 highlights prevention research priority topics that emerge as key areas that could be addressed through this NOSI.

Office of Research on Women’s Health (ORWH):

ORWH encourages submissions considering sex (the biological variable), gender (socially constructed and enacted roles and behaviors which occur in a historical and cultural context and vary across societies and over time), and their intersections with other social determinants of health, such as:

  • Developing and testing culturally competent & gender-responsive interventions to mitigate disparities in physical activity
  • Community-engaged research to develop and test interventions to increase physical activity
  • Developing and testing interventions to enhance women’s and girls physical activity across the life course, including during adolescence, pregnancy and the postpartum period, and the menopausal transition
  • Evaluating interventions to address built environment-related barriers that constrain physical activity among low-resource populations of women

Application and Submission Information

This notice applies to due dates on or after June 5, 2021 and subsequent receipt dates through February 16, 2024.

  • For funding consideration, applicants must include NOT-OD-21-087 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff/Scientific Contacts listed on this NOSI well in advance of the application receipt date to better determine appropriateness and interest of the relevant Institute.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Bramaramba Kowtha MS, RDN, LDN
Office of Disease Prevention (ODP)
Telephone: 301-435-8052
Email: bramaramba.kowtha@nih.gov

Frank Perna, Ed.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6782
Email:pernafm@mail.nih.gov

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email:lanay.mudd@nih.gov

Lyndon Joseph, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email:josephlj@mail.nih.gov

Stephanie M. George, Ph.D., MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-4974
Email: stephanie.george@nih.gov

Toyin Ajisafe, Ph.D.
National Center for Medical Rehabilitation Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-9242
Email: toyin.ajisafe@nih.gov

Judith A. Cooper, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301 496 5061
Email: Cooperj@nidcd.nih.gov 

Susan T. Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-640-9642
Email: Susan.Azrin@nih.gov

Nancy L. Jones, Ph.D., M.S.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email:nancy.jones@nih.gov

Amanda Alise Price, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-827-8391
Email:amanda.price2@nih.gov

Dana Wolff-Hughes, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-0979
Email: dana.wolff@nih.gov

Elizabeth Barr, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 30-1-402-7895
Email: elizabeth.barr@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices