Blood Pressure, Diabete Mellitus, Lipid Disorder, PreDiabetes, Weight Loss
Conditions
Keywords
weight loss, body composition, lipids, hemoglobin A1c, blood pressure
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.
Interventions
BEHAVIORALLow-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.
Sponsors
Physicians Committee for Responsible Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective interventional study without a control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanita J Rahman, MD
Physicians Committee for Responsible Medicine
Outcome results
None listed