Obesity
Conditions
Keywords
veteran, obesity, personalized genomics
Brief summary
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.
Detailed description
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.
Interventions
GENETICPersonalized Genomics
A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
GENETICUsual Care
Patients receive the same dietary recommendation regardless of their genetic information
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Veterans able to receive care at the VASDHS and planning to start the MOVE! program. 2. Veterans able to understand and consent to the study. 3. BMI equal to or greater than 30 kg/m2.
Exclusion criteria
1. Veterans unable to receive care at the VASDHS. 2. Veterans unable to understand the consent process at the discretion of the PI. 3. Active substance abuse or substance dependence disorder 4. Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments 5. Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG. 6. Uncontrolled thyroid disease as measured by a TSH above or below the normal range. 7. Body mass index \< 30 kg/m2. 8. Chronic kidney disease stage III or higher by National Kidney Foundation criteria (GFR = 30-59 ml/min). 9. New York Heart Association's functional classification of congestive heart failure above Class I (not limited with normal physical activity by symptoms; Class II occurs when ordinary physical activity results in fatigue, dyspnea, or other symptoms). 10. Sodium or potassium outside the normal range. 11. Edema requiring the use of daily diuresis with furosemide, bumex or other diuretic (does not include hydrochlorthiazide). 12. The use of high dose oral corticosteroids (above replacement doses). 13. Veterans deficient in 25-OH vitamin D (\<20 units/dl). 14. Veterans with fasting LDL \> 190 mg/dl. 15. Veterans with fasting triglyceride levels \> 1000 mg/dl. 16. Excessive caffeine use (\>6 caffeinated beverages/days). 17. Prior gastrointestinal surgery with the exception of distal appendectomy. 18. Acute infections or current use of antibiotic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Weight Loss of 5% or More at 8 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Weight Loss of 5% or More at 24 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 26 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Primary Endpoint Measure | Lost to Follow-up | 0 | 2 |
| Primary Endpoint Measure | Physician Decision | 0 | 1 |
| Primary Endpoint Measure | Withdrawal by Subject | 1 | 1 |
| Secondary Endpoint Measure | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Usual Care | Total | Personalized Genomics |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 12.3 | 51.1 years STANDARD_DEVIATION 12.9 | 48.4 years STANDARD_DEVIATION 13.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 13 Participants | 25 Participants | 12 Participants |
| Region of Enrollment United States | 20 participants | 46 participants | 26 participants |
| Sex: Female, Male Female | 3 Participants | 13 Participants | 10 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 26 |
| other Total, other adverse events | 0 / 20 | 0 / 26 |
| serious Total, serious adverse events | 0 / 20 | 0 / 26 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Weight Loss of 5% or More at 8 Weeks | 7 Participants |
| Personalized Genomics | Number of Participants With Weight Loss of 5% or More at 8 Weeks | 7 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.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Weight Loss of 5% or More at 24 Weeks | 5 Participants |
| Personalized Genomics | Number of Participants With Weight Loss of 5% or More at 24 Weeks | 7 Participants |