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

P

Physicians Committee for Responsible Medicine

Status

Not yet enrolling

Conditions

Type 2 Diabetes
Overweight and Obese Adults

Treatments

Behavioral: Low-fat, vegan diet

Study type

Interventional

Funder types

Other

Identifiers

NCT07095543
Pro00087270

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Low-fat, vegan diet
Experimental group
Description:
All participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group.
Treatment:
Behavioral: Low-fat, vegan diet

Trial contacts and locations

0

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Central trial contact

Vanita Rahman, MD, DipACLM; Roxanne Becker, MBChB, DipIBLM

Data sourced from clinicaltrials.gov

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