Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment

June 29, 2021 updated by: Evan Forman, Drexel University

A Pilot Study of a Novel Ad Libitum Plant-Based Behavioral Weight Loss Treatment

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Weight Eating and Lifestyle Science Center, Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Retention feasibility as assessed by the number of participants successfully retained in the intervention
Time Frame: Week 12 (post-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
Time Frame: Week 12 (post-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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness of the intervention on weight loss, as assessed by self-reported weight from baseline to post-intervention
Time Frame: Measured once weekly from Week 0 (baseline) to Week 12 (post-intervention), and at 3-month follow-up
Weight loss will be self-reported by participants weekly, and at baseline, mid-treatment, post-treatment, and 3-month follow-up. To evaluate the preliminary effectiveness of the intervention on weight loss, percent weight change from baseline to post-intervention will be evaluated. Preliminary weight loss effectiveness will be defined as at least 50% of participants losing at least 5% of their initial body weight by post-treatment.
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
Time Frame: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Dietary intake will be assessed using a food frequency questionnaire tailored to examine adherence to the prescribed intervention (whole food plant-based) diet. A dietary adherence index ranging from 0 (no adherence) to 100 (complete adherence) will be created, and preliminary dietary change effectiveness will be defined as at least 80% of participants improved their dietary adherence score by at least 20% by post-treatment.
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
Time Frame: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Waist circumference will be self-reported by participants weekly, and at baseline, mid-treatment, post-treatment, and 3-month follow-up. To evaluate the preliminary effectiveness of the intervention on waist circumference, waist circumference change from baseline to post-intervention will be examined. Preliminary weight loss effectiveness will be defined as at least 50% of participants losing at least 5% of their initial waist circumference by post-treatment.
Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness of the intervention on quality of life, as assessed by self-reported quality of life from baseline to post-intervention
Time Frame: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Quality of life will be assessed using the 36-item Short-Form General Health Survey (SF-36). The SF-36 assesses eight domains: physical functioning, limits due to physical health, pain, general health, energy/fatigue, social functioning, emotional wellbeing, and mental health. Scores in each domain are converted to a scale from 0 to 100, with higher scores indicating better functioning in each domain. This scale produces both physical and mental health component summaries, both of which will be examined. A reliable change index at the .20 level will be calculated for both the physical- and mental- health-related component scores. If the product exceeds a z-score of 1.282 at post-treatment, reflecting 80% confidence, then results will be defined as suggestive of preliminary quality of life effectiveness.
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)
Time Frame: Week 0 (baseline) and Week 12 (post-treatment)
To assess plant-based diet history, a plant-based diet familiarity score will be computed from participants' self-reported familiarity with plant-based diets, reported on a scale ranging from 0 (Not at all familiar) to 4 (Very familiar), and from reports of whether they have eaten a plant-based diet in the past, for at least 3-months. Participants will be given 4 points if previously vegan, 3 if previously vegetarian, 2 if previously pescatarian or 1 if previously semi-vegetarian ("flexitarian"). These scores will be added to self-reported plant-based diet familiarity, resulting in a "plant-based diet familiarity" score that could range from 0 to 7. To evaluate the potential moderating effect of plant-based diet history on weight loss outcomes, the correlation between plant-based diet history and post-treatment percent weight loss will be examined.
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)
Time Frame: Week 6 (mid-treatment) and Week 12 (post-treatment)
To assess social support vs. social sabotage, participants will complete the Social Support and Sabotage Scale from Ball & Crawford (2006). On this measure, participants separately rate the degree to which friends and family act in ways that support or hinder their healthy eating efforts with a Likert scale ranging from 1 (Almost never) to 5 (Almost always). Scores will be averaged for each subscale to compute: 1) support for health behaviors from friends, 2) support for health behaviors from family, 3) sabotage for health behaviors from friends, and 4) sabotage for health behaviors from family. To evaluate the potential moderating effect of social support vs. social sabotage on weight loss outcomes, the correlations between social support vs. social sabotage for health behavior scores and post-treatment percent weight loss will be examined.
Week 6 (mid-treatment) and Week 12 (post-treatment)
Association between internal disinhibition at Week 0 (baseline) and percent weight loss at Week 12 (post-treatment)
Time Frame: Week 0 (baseline) and Week 12 (post-treatment)
To assess internal disinhibition, participants will complete the disinhibition subscale from the Mindful Eating Questionnaire (MEQ; Framson et al., 2009). Responses are on a Likert scale ranging from 1 (Never/Rarely) to 4 (Usually/Always). Scores for each item are averaged to compute an overall disinhibition score. To evaluate the potential moderating effect of internal disinhibition on weight loss outcomes, the correlation between internal disinhibition and post-treatment percent weight loss will be examined.
Week 0 (baseline) and Week 12 (post-treatment)
Association between self-compassion at Week 0 (baseline) and percent weight loss at Week 12 (post-treatment)
Time Frame: Week 0 (baseline) and Week 12 (post-treatment)
To assess self-compassion, participants will complete the Self-Compassion Scale-Short Form, which assess how participants generally treat themselves during difficult times. Responses are on a Likert scale ranging from 1 (Almost never) to 5 (Almost always). Scores for each item are averaged to compute an overall self-compassion score. To evaluate the potential moderating effect of self-compassion on weight loss outcomes, the correlation between self-compassion and post-treatment percent weight loss will be examined.
Week 0 (baseline) and Week 12 (post-treatment)
Association between psychological flexibility at Week 6 (mid-treatment) and percent weight loss at Week 12 (post-treatment)
Time Frame: Week 6 (mid-treatment) and Week 12 (post-treatment)
To assess psychological flexibility, participants will complete the personalized psychological flexibility index, which assesses the ability to pursue valued life aims despite the presence of distress. Responses are on a Likert scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). Scores for each item are averaged to compute an overall psychological flexibility score. To evaluate the potential moderating effect of psychological flexibility on weight loss outcomes, the correlation between psychological flexibility and post-treatment percent weight loss will be examined.
Week 6 (mid-treatment) and Week 12 (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evan M Forman, Ph.D., Drexel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EATVEG838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared in a public repository stripped of any identifying participant information.

IPD Sharing Time Frame

Immediately following manuscript publication, the study data study and statistical code used for analyses will be shared.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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