The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 3
- Primary Endpoint
- Weight loss
Study Overview
Brief Summary
This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.
Detailed Description
This will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. The program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin A1c, and body composition before and after starting the program. The price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women age ≥18 years of age
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
- •Lack of English fluency
- •Inability to maintain current medication regimen
- •Inability or unwillingness to participate in all components of the study
Arms & Interventions
Low-fat plant-based diet
For 12 weeks, participants will follow a diet comprised of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.
Intervention: Low-fat plant-based diet (Behavioral)
Outcomes
Primary Outcomes
Weight loss
Time Frame: Change from baseline to 12 weeks
With participants wearing light, indoor clothing but without shoes, body weight will be measured to the nearest 0.1 kg, using a digital scale. Body weight will also be assessed at each weekly session, but only data from the week 1 (pre-program) and week 12 (post-program) will be included in the analysis.
Secondary Outcomes
- hemoglobin A1c(Change from baseline to 12 weeks)
- Plasma cholesterol and triacylglycerol concentrations(Change from baseline to 12 weeks)
- Blood pressure(Change from baseline to 12 weeks)
- Body Composition(Change from baseline to 12 weeks)