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This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator | Usual care for veterans as part of the MOVE! program |
|
| Personalized Genomics | Active Comparator | Personalized genomics information from the FIT Test, Pathway Genomics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Genomics | Genetic | A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Weight Loss of 5% or More at 8 Weeks | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Weight Loss of 5% or More at 24 Weeks | 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. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25769412 | Derived | Frankwich KA, Egnatios J, Kenyon ML, Rutledge TR, Liao PS, Gupta S, Herbst KL, Zarrinpar A. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1625-1632.e1. doi: 10.1016/j.cgh.2015.02.044. Epub 2015 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information |
| FG001 | Personalized Genomics | Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Endpoint Measure |
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| |||||||||||||||||||||
| Secondary Endpoint Measure |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information |
| BG001 | Personalized Genomics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Weight Loss of 5% or More at 8 Weeks | 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. | Posted | Count of Participants | Participants | 8 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amir Zarrinpar, MD, PhD, Assistant Professor of Gastroenterology | VA San Diego Health Sciences | 858-246-1665 | azarrinpar@health.ucsd.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Genetic | Patients receive the same dietary recommendation regardless of their genetic information |
|
|
| Physician Decision |
|
| NOT COMPLETED |
|
|
Personalized genomics information from the FIT Test, Pathway Genomics
Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Weight Loss of 5% or More at 24 Weeks | 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. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Personalized Genomics | Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise | 0 | 26 | 0 | 26 | 0 | 26 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |