Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment

NCT04892030 | Completed

• 1 other identifier: EATVEG838
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).

Conditions

Obesity; Overweight

Keywords

Weight loss; Behavioral weight loss; Overweight and obesity; Plant-based; Lifestyle modification

Outcome Measures

Primary Outcomes (2)

• Retention feasibility as assessed by the number of participants successfully retained in the intervention

  The number of participants who are retained in the study, as defined by completing the post-treatment assessment and at least 10 out of 12 of the weekly intervention modules. Successful retention will be defined as at least 80% of participants being retained in the study.

  Week 12 (post-intervention)

• Acceptability as assessed by self-reported acceptability of the intervention

  Acceptability will be assessed with three items, in which participants will report the degree to which they were satisfied with the intervention, found the intervention to be helpful, and the likelihood that they would recommend it to family/friends on a Likert scale ranging from 1 (Not at all) to 5 (Very much).

  Week 12 (post-intervention)

Secondary Outcomes (3)

• Preliminary effectiveness of the intervention on weight loss, as assessed by self-reported weight from baseline to post-intervention

  Measured once weekly from Week 0 (baseline) to Week 12 (post-intervention), and at 3-month follow-up

• Preliminary effectiveness of the intervention on dietary intake, as assessed by self-reported dietary intake from baseline to post-intervention

  Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up

• Preliminary effectiveness of the intervention on waist circumference, as assessed by self-reported waist circumference from baseline to post-intervention

  Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up

Other Outcomes (6)

• Preliminary effectiveness of the intervention on quality of life, as assessed by self-reported quality of life from baseline to post-intervention

  Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up

• Association between plant-based diet history at Week 0 (baseline) and percent weight loss at Week 12 (post-treatment)

  Week 0 (baseline) and Week 12 (post-treatment)

• Association between social support vs. social sabotage at Week 6 (mid-treatment) and percent weight loss at Week 12 (post-treatment)

  Week 6 (mid-treatment) and Week 12 (post-treatment)

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies remotely, through an e-learning platform.

Behavioral: Whole Food Plant-Based Behavioral Weight Loss Treatment

Interventions

Whole Food Plant-Based Behavioral Weight Loss Treatment BEHAVIORAL

Over the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75
• Current BMI ≥ 25 kg/m2
• Reporting a desire to lose weight
• Have at-home internet access
• Proficiency in speaking, reading, and writing English
• Willing to consume a whole foods plant-based diet for the study duration

You may not qualify if:

• Use of medications for weight loss
• Recent weight loss (≥5% weight loss in prior 3-months)
• Current or planned pregnancy within the study period
• History of bariatric surgery
• Currently following a low-fat plant-based diet
• Diagnosis of a serious medical condition influencing weight, appetite, or eating behavior
• Diagnosis of a serious psychiatric condition that may influence weight, appetite, or eating behavior
• Current substance use disorder
• Participation in a concurrent weight loss program
• Planning on quitting smoking over the intervention period (if current smoker)
• Eating pathology (lifetime history of an eating disorder, ≥ 9 binge eating episodes in the past 3 months, or \> 5 compensatory episodes in the past 3 months)

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Weight Eating and Lifestyle Science Center, Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Chwyl C, Wright N, M Turner-McGrievy G, L Butryn M, M Forman E. Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results. JMIR Form Res. 2022 Jun 23;6(6):e37414. doi: 10.2196/37414.

  PMID: 35737443 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Evan M Forman, Ph.D.

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology, Drexel University

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 19, 2021
• Study Start: November 25, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Immediately following manuscript publication, the study data study and statistical code used for analyses will be shared.

Locations

US (1)