Plant-Based Online Weight Loss Through Education and Resources Program and Study (POWER)

July 30, 2025 updated by: Physicians Committee for Responsible Medicine

Feasibility, Implementation, and Efficacy of a Plant-based Online Weight Loss Through Education and Resources Program and Study (POWER Study)

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will meet with a physician and a registered dietitian once a week to learn about a plant-based diet and receive support and practical help in making the dietary changes. Body composition, blood sugar control, cholesterol levels, and food costs will be measured at the start and end of the study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will participate in weekly physician- and dietitian-lead group classes and will receive education about a plant-based diet as well as support and practical tips for implementing the dietary changes. Participants will receive baseline and 12 week assessments including a DXA scan to assess body composition, HbA1c, lipid panel, and a food cost analysis.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Contact

  • Name: Vanita Rahman, MD, DipACLM
  • Phone Number: 202-567-2546
  • Email: vrahman@pcrm.org

Study Contact Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • U.S. men and women meeting the age of majority, defined as follows:

Age 19 or older in Nebraska and Alabama. Age 21 or older in Puerto Rico. Age 18 or older in all other states.

  • Able and willing to travel to Washington DC for a dual-energy х-rау absorptiometry (DXA) scans before and after the program.
  • Able and willing to complete laboratory assessments at a local LabCorp facility before and after the program.
  • Able and willing to participate in all components of the study.
  • BMI of 25 or more (23 or more in persons of Asian origin).
  • Access to the internet.
  • English fluency.

Exclusion Criteria:

  • Use of recreational drugs in the past 6 months.
  • Pregnancy or intention to become pregnant during the study period, as verified by self-report.
  • Unstable medical or psychiatric illness.
  • Inability to maintain medication regimen as prescribed by personal healthcare provider.
  • Current or expected use of any weight loss medication during the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
  • Use of any weight loss medication within the 12 months preceding the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
  • Body weight greater than 182 kg.
  • Current diagnosis of eating disorder.
  • Intention to follow another weight loss method during the study period.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-fat, vegan diet
All participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group.
Behavioral: Low-fat, vegan diet
All participants will be asked to follow a low-fat vegan diet for the duration of the study. Participants will attend weekly classes where they we receive education and support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of an online plant-based weight loss program in the community setting.
Time Frame: From baseline to the end of the intervention at 12 weeks.
Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments.
From baseline to the end of the intervention at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glycated hemoglobin.
Time Frame: From baseline to the end of the intervention at 12 weeks.
A1c will be measured using standard methods.
From baseline to the end of the intervention at 12 weeks.
Changes in total and LDL cholesterol levels.
Time Frame: From baseline to the end of the intervention at 12 weeks.
Total and LDL cholesterol levels will be measured using standard methods.
From baseline to the end of the intervention at 12 weeks.
Changes in body composition.
Time Frame: From baseline to the end of the intervention at 12 weeks.
Body composition will be measured by dual energy x-ray absorptometry (Lunar iDXA, GE Healthcare; Madison, WI) with Encore® 2005 v.9.15.010 software. The iDXA can measure body composition with low x-ray exposure and short scanning time. The iDXA unit will be calibrated daily using the GE Lunar calibration phantom, and a trained operator will perform all scans following standard protocol for participant positioning. The iDXA is equipped with the CoreScan module (GE Healthcare, Madison, WI), which can also provide an estimate of visceral adipose tissue volume and mass.
From baseline to the end of the intervention at 12 weeks.
Food costs of a baseline diet and a low-fat plant-based diet.
Time Frame: From baseline to the end of the intervention at 12 weeks.
Study participants will be asked to provide a food consumption record of three consecutive days (including two weekdays and one weekend day). Participants will be asked to include the specific brands, portions, names of retailers and restaurants where the food was purchased. A study team member will review the food record with the participants. We will then calculate the total cost of the food consumed during the 3-day period using cost data from the retailers' and restaurants' websites or by calling the specific restaurants and retailers.
From baseline to the end of the intervention at 12 weeks.

Collaborators and Investigators

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

Sponsor

Physicians Committee for Responsible Medicine

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 (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

July 15, 2025

First Submitted That Met QC Criteria

July 23, 2025

First Posted (Actual)

July 31, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00087270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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