Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

Sponsor

Physicians Committee for Responsible Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04091516

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Blood Pressure Lipid Disorder PreDiabetes Diabete Mellitus	Behavioral: Low-fat plant-based diet	N/A

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

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective interventional study without a control groupProspective interventional study without a control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting

Actual Study Start Date :

Aug 30, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Behavioral: Low-fat plant-based diet Participants will follow a diet that consists 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.

Arm

Intervention/Treatment

Other: 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.

Behavioral: Low-fat plant-based diet

Participants will follow a diet that consists 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.

Outcome Measures

Primary Outcome Measures

Weight loss [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 Outcome Measures

Blood pressure [Change from baseline to 12 weeks]
Blood pressure will be measured using an automated oscillometric device.
Plasma cholesterol and triacylglycerol concentrations [Change from baseline to 12 weeks]
Will be measured using standard methods.
hemoglobin A1c [Change from baseline to 12 weeks]
will be measured using standard methods.
Body Composition [Change from baseline to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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