Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Drexel University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Weight Change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). The 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). Assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). Acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 27-50 kg/m2
- •Ages 18-75 years
- •Resides in the U.S.
- •Consistent access to internet at home
- •Proficient skill level in speaking, writing, and understanding English
- •Reporting a desire to lose weight
- •Consistently available for 15-minute once-weekly video appointment between the hours of 8 AM and 7 PM EST
- •Willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration
- •Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
Exclusion Criteria
- •Currently pregnant or breastfeeding or planned pregnancy within the study period
- •Recent weight loss (≥ 5% weight loss in 3-months prior to the study)
- •History of bariatric surgery
- •Currently following a low-fat plant-based diet
- •Medical condition (e.g., cancer, type I diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
- •Recently began or changed the dose of a medication that can cause significant change in weight
- •Planning on quitting cigarette smoking over the program period
- •Participation in a concurrent weight loss program during the study period
- •Medical diagnosis currently influencing weight or appetite
- •Medical condition that would limit ability to participate in this program (for example, mild stroke, diabetes if taking insulin, head trauma, cognitive disorder)
Outcomes
Primary Outcomes
Weight Change
Time Frame: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Weight loss will be self-reported by participants using a standardized weighing procedure. Participants will weigh themselves in lightweight clothes without shoes with a digital scale accurate to 0.1 kg. Percent weight loss at 6-months will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.
Secondary Outcomes
- Subjective Appetite as assessed by visual analogue scale (VAS)(Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).)