Nutrigenomics: Personalizing Weight Loss for Obese Veterans
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nutrigenomics: Personalizing Weight Loss for Obese Veterans|
- 5% weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Our primary hypotheses are that more obese veterans in the MOVE! program will lose greater or equal to 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 weeks.
- 5% weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]We hypothesize that more veterans in the genomic group that lose greater or equal to 5% weight loss at 8 weeks will maintain this weight loss after 24 weeks compared to veterans in the usual care group.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Usual Care
Usual care for veterans as part of the MOVE! program
Active Comparator: Personalized Genomics
Personalized genomics information from the FIT Test, Pathway Genomics
Genetic: Personalized Genomics
A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Other Name: FIT test from Pathway Genomics, Inc.
About 35% of veterans are obese. The MOVE! program is a nation-wide 8-week program of group classes nationally to help obese veterans lose weight. While the program is successful for some veterans, about 75% of veterans are unable to lose ≥5% of their weight 24 weeks after MOVE! New methods are needed to help obese veterans seeking weight loss. Using personalized genomic information dictating a specific diet, and information on exercise and eating behaviors, may be one means to help promote weight loss. Just a single nucleotide change or polymorphism (SNP) in a gene can increase a person's risk for obesity, or change their lipid profile in response to the consumption of different macronutrients such as of fats or carbohydrates. Over 54 genetic loci have been associated with obesity phenotypes and clinical studies are now reporting associations between SNPs and/or functional alterations of gene expression (epigenetics) and the ability to lose weight or not. We will implement a randomized clinical trial to test a set of genomic data called the FIT™ test (Pathway Genomics™) containing information on SNPs that affect obesity risk, confer specific diet recommendations, outline eating behaviors and suggest responses to various exercise regimens. The overall goal of this project is to evaluate if this supplemental genetic information with a genomically-derived diet built around packaged meals to improve adherence, in parallel with the MOVE! program at the VA in San Diego, will promote weight loss in more obese veterans than those receiving usual care and eating diets based around packaged meals. Our primary hypotheses are that more obese veterans in the MOVE! program will lose 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 or 24 weeks. We also hypothesize that more veterans in the genomic group that lose 5% weight loss at 8 weeks will maintain this weight loss after 24 weeks compared to veterans in the usual care group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859403
|Contact: Karen L Herbst, PhD, MD||858-552-8585 ext firstname.lastname@example.org|
|Contact: Amir Zarrinpar, MDemail@example.com|
|United States, California|
|VA San Diego Healthcare System||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Karen L Herbst, PhD, MD 858-552-8585 ext 7384 firstname.lastname@example.org|
|Contact: Amir Zarrinpar, MD 858-442-1359 email@example.com|
|Principal Investigator: Karen L Herbst, PhD, MD|
|Sub-Investigator: Amir Zarrinpar, MD|