Plant-Based Online Weight Loss Through Education and Resources Program and Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhysicians Committee for Responsible Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Low-fat, vegan diet
BehavioralAll 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Low-fat, vegan dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The feasibility of an online plant-based weight loss program in the community setting.
Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments.
Time frame
From baseline to the end of the intervention at 12 weeks.Secondary outcomes
1
Changes in glycated hemoglobin.
A1c will be measured using standard methods.
Time frame
From baseline to the end of the intervention at 12 weeks.2
Changes in total and LDL cholesterol levels.
Total and LDL cholesterol levels will be measured using standard methods.
Time frame
From baseline to the end of the intervention at 12 weeks.3
Changes in body composition.
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.
Time frame
From baseline to the end of the intervention at 12 weeks.4
Food costs of a baseline diet and a low-fat plant-based diet.
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.
Time frame
From baseline to the end of the intervention at 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov