N/A
N=207
Considering Patient Diet Preferences to Optimize Weight Loss
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01152359 ↗Enrolled (actual)
207
Serious AEs
3.9%
Results posted
Oct 2014
Primary outcome: Primary: Percent Change in Body Weight From Baseline to 48 Weeks — -4.2; -5.3 percentage of weight change — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Choice (Behavioral); Control (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Body Weight From Baseline to 48 Weeks |
-4.2; -5.3 | <0.05 sig |
| SECONDARY Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet) |
9.4; 10.3 | 0.66 |
| SECONDARY Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks |
10.5; 11.2 | 0.65 |
Summary
Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Adherence to dietary therapy for obesity is often inadequate, possibly because patients' food preferences are not considered during dietary counseling. Allowing patients to choose a diet based on their food preferences may increase their motivation to adhere to diet counseling. This, in turn, could enhance their weight loss success and, ultimately, reduce the many health complications and costs of obesity. The proposed study will examine whether assessing a person's food preferences, and then allowing the person to choose from two commonly prescribed diets, results in greater weight loss success.
Eligibility Criteria
Inclusion Criteria
- Body mass index 30 or greater
- Stable health
- Desire to lose weight
- Agrees to attend regular visits
- Access to telephone and reliable transportation
- Has a Veterans Affairs Medical Center (VAMC) provider
Exclusion Criteria
- Certain chronic or unstable disease (kidney or liver disease, type 1 diabetes, hemoglobin A1c 12% or more, insulin use, unstable heart disease, transplant recipient, blood pressure 160/100 or greater, fasting blood triglycerides 600 or greater, LDL cholesterol 190 or greater)
- Pregnancy, breastfeeding, lack of birth control
- Active dementia, psychiatric illness, or substance abuse (past year)
- Weight loss therapy in previous month
- Pacemaker or defibrillator
- Enrolled in another study that might affect measurements
- Previously in study of low-carbohydrate or low-fat diet for weight loss
- Unable to complete all study measures
Data sourced from ClinicalTrials.gov (NCT01152359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.