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

NCT ID: NCT05337150

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-29
• Study Completion Date: 2023-03-24

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle Modification with a Balanced Calorie Deficit Diet

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).

Group Type: EXPERIMENTAL

Lifestyle Modification Intervention

Intervention Type: BEHAVIORAL

For the first 12-weeks of the study, participants will complete weekly web modules in which they will learn cognitive-behavioral strategies to support lifestyle modification. Participants will also receive weekly phone coaching calls for the first 12-weeks of the study, and monthly coaching calls thereafter for the remainder of the 24-week study period.

Balanced Calorie Deficit Eating Plan

Intervention Type: BEHAVIORAL

Participants will be prescribed a calorie target between 1200 and 1800 depending upon baseline weight and personal preference. Participants will be asked to monitor their dietary intake using MyFitnessPal and to submit food logs weekly. Calorie reduction content will be based primarily on the Diabetes Prevention Program protocol and adapted from existing behavioral treatment protocols. Individuals will receive general guidelines on eating a healthy diet, including reducing saturated fat, processed foods, refined sugars, and refined carbohydrates, and increasing intake of lean proteins, whole grains, and fruits and vegetables, but will be encouraged to flexibly decide which areas of their diet to modify to reduce calorie intake.

Lifestyle Modification with an 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)

Group Type: EXPERIMENTAL

Lifestyle Modification Intervention

Intervention Type: BEHAVIORAL

For the first 12-weeks of the study, participants will complete weekly web modules in which they will learn cognitive-behavioral strategies to support lifestyle modification. Participants will also receive weekly phone coaching calls for the first 12-weeks of the study, and monthly coaching calls thereafter for the remainder of the 24-week study period.

Ad Libitum Whole Food Plant-Based Eating Plan

Intervention Type: BEHAVIORAL

Participants will be prescribed a whole food plant-based (WFPB) low-fat vegan diet promoting intake of fruits, vegetables, starches, legumes, and whole grains. Participants will be encouraged to avoid processed foods, refined oils, and animal products (meat, fish, eggs, and dairy products), and to minimize consumption of high-fat plant-based foods. An adapted traffic-light diet chart will outline foods to eat daily, limit, and avoid. Participants will be advised to eat until satiation and not restrict energy intake. Participants will be asked to consume 50 μg vitamin B12 (methylcobalamin) daily. WFPB nutrition counseling content will be based upon existing successful programs. Each week, participants will complete a simplified dietary self-monitoring food frequency questionnaire aligned to correspond with the traffic light diet chart.

Interventions

Lifestyle Modification Intervention

For the first 12-weeks of the study, participants will complete weekly web modules in which they will learn cognitive-behavioral strategies to support lifestyle modification. Participants will also receive weekly phone coaching calls for the first 12-weeks of the study, and monthly coaching calls thereafter for the remainder of the 24-week study period.

Intervention Type: BEHAVIORAL

Balanced Calorie Deficit Eating Plan

Participants will be prescribed a calorie target between 1200 and 1800 depending upon baseline weight and personal preference. Participants will be asked to monitor their dietary intake using MyFitnessPal and to submit food logs weekly. Calorie reduction content will be based primarily on the Diabetes Prevention Program protocol and adapted from existing behavioral treatment protocols. Individuals will receive general guidelines on eating a healthy diet, including reducing saturated fat, processed foods, refined sugars, and refined carbohydrates, and increasing intake of lean proteins, whole grains, and fruits and vegetables, but will be encouraged to flexibly decide which areas of their diet to modify to reduce calorie intake.

Intervention Type: BEHAVIORAL

Ad Libitum Whole Food Plant-Based Eating Plan

Participants will be prescribed a whole food plant-based (WFPB) low-fat vegan diet promoting intake of fruits, vegetables, starches, legumes, and whole grains. Participants will be encouraged to avoid processed foods, refined oils, and animal products (meat, fish, eggs, and dairy products), and to minimize consumption of high-fat plant-based foods. An adapted traffic-light diet chart will outline foods to eat daily, limit, and avoid. Participants will be advised to eat until satiation and not restrict energy intake. Participants will be asked to consume 50 μg vitamin B12 (methylcobalamin) daily. WFPB nutrition counseling content will be based upon existing successful programs. Each week, participants will complete a simplified dietary self-monitoring food frequency questionnaire aligned to correspond with the traffic light diet chart.

Intervention Type: BEHAVIORAL

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Forman, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HEALTHQUEST

Identifier Type: -

Identifier Source: org_study_id