Notice Number: NOT-CA-15-042
Key Dates
Release Date: October 29, 2015
Response Date: December 4, 2015
None
Issued by
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose
The NIH is seeking information regarding existing large randomized controlled trials (RCTs) testing lifestyle interventions for weight loss among adults. Existing RCTs should have available biospecimens that may be suitable for a large collaborative genome wide study, using either genome wide association study (GWAS) or next generation sequencing study designs or platforms (e.g. Whole genome sequencing (WGS)), to discover genetic variants associated with intentional weight loss. This information is needed to assess the feasibility of pooling RCTs to examine the well-established variability in weight loss treatment response and has the potential to improve treatment outcomes.
Background
The NIH has made a large investment in the prevention and treatment of obesity, which includes the funding of RCT behavioral weight loss interventions and the application of genetic and genomic technology to understand the underlying etiology of obesity. Genomic and genetic studies have advanced our knowledge through the identification of genes and susceptibility alleles that increase risk for obesity. However, it is unclear whether these variants also contribute to weight change, as the genetic determinants of weight loss may differ from those associated with obesity. This request seeks information on existing weight loss RCTs that could be used successfully in genome wide studies, i.e. GWAS or next-generation sequencing, where large sample sizes are necessary for association studies.
NIH believes that there is considerable value to the scientific community in forming a large consortium to explore the contribution of germline genetic variation to intentional weight loss. The NIH seeks to pursue the discovery of genetic variants associated with weight change (weight loss/weight maintenance/weight regain) in multiple race and ethnic groups. The proposed technologies allow for analysis of many common genetic variants to identify traits that are associated with weight change, are economically feasible, and with the consortium, will have sufficient statistical power. GWAS or WGS coupled with existing phenotype and outcome data will provide a wealth of information to aid in unraveling the underlying contributors to weight change. The resulting dataset will become a common resource for the scientific community and may help to guide future behavioral weight loss interventions and advance the field of precision medicine.
Information Requested
The NIH seeks information regarding the availability of existing large RCTs of lifestyle weight loss interventions for adults with available GWAS data or biospecimens that could be used for genome wide studies, either using GWAS arrays or next generation sequencing (whole-exome or whole-genome sequencing). Biospecimens of interest include whole blood, buffy coat, saliva, blood spot or stored DNA samples which provide DNA of adequate quality and quantity for genome wide studies. Such samples should already be part of an ongoing or completed study and studies should have phenotypes previously measured. Samples and associated data should be available and transferrable. Trial participants should have been consented for data sharing, including genomic data (e.g. GWAS, whole-exome, or whole-genome sequencing) or the study has the ability to obtain consent post-hoc.
The NIH seeks comments on any or all of the following topics:
- The availability of RCTs of behavioral weight loss interventions with available biospecimens (e.g. whole blood; buffy coat; saliva; blood spot; DNA) or GWAS data
- For each behavioral weight loss RCT, information is sought on the following:
- Sample size per arm;
- Race/ethnicity, age, and sex of participants;
- Description of patient recruitment including inclusion and exclusion criteria;
- Patient consent for data sharing and genomic data sharing;
- Patient consent for genotyping genetic studies;
- Available Biospecimens for DNA extraction, or available extracted DNA, and years since specimens or DNA was collected;
- Amount of high quality DNA
- Methods and frequency of collection for measurements performed of phenotypes such as weight, diet, physical activity and other relevant behavioral phenotypes
- The opportunities for replication of individual findings from the proposed project
- The barriers (if any) to sharing genetic data in dbGAP if study joins consortium. Include options in data sharing that may help to overcome these barriers
- Most recent publications and/or websites that provide comprehensive details of the populations and interventions in treatment and control arms. When possible, include relevant PMIDs.
How to Submit a Response
Responses to the RFI will be accepted until December 4, 2015. Respondents are advised that the NIH is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No basis for claims against the Federal Government shall arise as a result of a response to this request for information or from the Federal Government’s use of such information. All comments must be submitted to: collinsta@mail.nih.gov.
Responses will be compiled and shared internally and with working groups convened by the NIH, as appropriate. The information provided in response may appear in reports. No proprietary, classified, confidential, or sensitive information should be included in your response.
This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government and the NIH. The NIH does not intend to award a cooperative agreement, grant, or contract on the basis of responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Based on the response to this RFI, the NIH may use the information gathered to develop a Request for Proposals (RFP), contract or other funding priorities and initiatives at an undetermined time in the future.
Additional comments relevant to this RFI and addressing issues that are not specifically mentioned above are also encouraged. We look forward to your input and hope that you will share this document with your colleagues.
Inquiries
Please direct all inquiries to:
Tanya Agurs-Collins
National Cancer Institute (NCI)
Telephone: 240-276-6956
Email: collinsta@mail.nih.gov:
Cashell Jaquish
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0447
Email: jaquishc@nhlbi.nih.gov
Robert W. Karp
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-8875
Email: karpr@extra.niddk.nih.gov
and Human Services (HHS)
