Status:
COMPLETED
Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
Lead Sponsor:
Drexel University
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05337150
Start Date
May 29 2022
End Date
March 24 2023
Last Update
September 14 2023
Active Locations (1)
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1
Drexel University
Philadelphia, Pennsylvania, United States, 19104