Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Lifestyle Modification Intervention; Behavioral: Balanced Calorie Deficit Eating Plan; Behavioral: Ad Libitum Whole Food Plant-Based Eating Plan

• Registration Number: NCT05337150
• Lead Sponsor: Drexel University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2022-05-29
• Status Verified: 2023-01
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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)
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan	Lifestyle Modification Intervention	Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products)
Lifestyle Modification with a Balanced Calorie Deficit Diet	Lifestyle Modification Intervention	Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal).
Lifestyle Modification with a Balanced Calorie Deficit Diet	Balanced Calorie Deficit Eating Plan	Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal).
Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan	Ad Libitum Whole Food Plant-Based Eating Plan	Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products)

Primary Outcome Measures

Name	Time	Method
Weight Change	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 Outcome Measures

Name	Time	Method
Subjective Appetite as assessed by visual analogue scale (VAS)	Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).	Subjective appetite will be assessed using 6 visual analogue scale items (VAS) inquiring about past-week hunger, fullness, the degree to which hunger made it difficult to follow the prescribed diet, preoccupation with thoughts of food, and being bothered by hunger on a visual analogue scale of 0-100. Scores on the fullness item will be reversed, such that higher scores will indicate greater subjective appetite.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States