Overweight and Obese Adults, Type 2 Diabetes
Conditions
Keywords
Plant-based diet, Vegan diet, type 2 diabetes, Weight loss, Overweight, Obesity, Cholesterol
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALLow-fat, vegan diet
All 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.
Sponsors
Physicians Committee for Responsible Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of an online plant-based weight loss program in the community setting. | From baseline to the end of the intervention at 12 weeks. | Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycated hemoglobin. | From baseline to the end of the intervention at 12 weeks. | A1c will be measured using standard methods. |
| Changes in total and LDL cholesterol levels. | From baseline to the end of the intervention at 12 weeks. | Total and LDL cholesterol levels will be measured using standard methods. |
| Changes in body composition. | From baseline to the end of the intervention at 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. |
| Food costs of a baseline diet and a low-fat plant-based diet. | From baseline to the end of the intervention at 12 weeks. | 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. |
Countries
United States
Contacts
CONTACTVanita Rahman, MD, DipACLM
CONTACTShannon Menhardt, MS, RD
Outcome results
None listed