Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
Completed · Not applicable
Conditions studied: Obesity, Overweight
In brief
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.
Key facts
- Study ID
- NCT05337150
- Run by
- Drexel University
- People needed
- 55
- Starts
- 2022-05-29
- Expected to finish
- 2023-03-24
- Last updated by the study team
- 2023-09-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- Acute suicidality
- Currently meets criteria for regular loss-of-control eating (i.e., ≥ 9 binge episodes in past 3 months
- Currently reports engaging in a compensatory behavior
Where it is running
- Drexel University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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