An interventional study of Plant-based diet and Control Diet in Overweight and Type2 Diabetes, sponsored by Physicians Committee for Responsible Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.
Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 22 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Physicians Committee for Responsible Medicine is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The diet group will be asked to follow a low-fat, vegan diet for 12 weeks
Other: Plant-based diet
Half of the participants will be asked to continue their usual diets for the 12-week study period.
Other: Control Diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Also known as: Vegan diet
Participants will be asked to continue their usual diets for the 12-week study period.
Body Weight
Anticipated weight-loss for intervention group compared with control group
Time frame: 12 weeks
Blood Pressure
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Time frame: 12 weeks
Plasma Lipids
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
Time frame: 12 weeks
Hemoglobin A1c
HbA1c will be measured as an index of glycemic control.
Time frame: 12 weeks
Fasting Plasma Glucose
Fasting Plasma Glucose will be measured as an index of glycemic control.
Time frame: 12 weeks
Absenteeism
Absenteeism from work will be assessed by self-report at baseline and final assessments.
Time frame: 12 weeks
Quality of Life: SF-36
Quality of life will be assessed using the SF-36, which is a brief health survey with 36 questions. The SF-36 provides an 8-scale profile of functional health and well-being scores, as well as psychometrically-based physical and mental health summary measures. The SF-36 is a general measure that has been administered across various age groups, disease spectra, and treatment regimens. Items on the SF-36 are scored on a scale of 0-100, with a higher score indicating better health-related quality of life.
Time frame: 12 weeks
Dietary Restraint, Disinhibition, Hunger
Participants will complete an Eating Inventory form, a highly reliable 51 item questionnaire providing quantitative measures of dietary restraint (21 questions), disinhibition (16 items), and hunger (14 questions). Scores for each sub-scale are calculated by summing respective items. The scale consists of 36 true=false items and 15 forced-choice format questions. Higher scores are indicative of greater dietary restraint, disinhibition and hunger. Its principal use in the current study will be as a gauge of ease in adapting to the intervention diet, which is indicated by changes in restraint and hunger scores.
Time frame: 12 weeks
Food Acceptability: The Food Acceptability Questionnaire
The Food Acceptability Questionnaire will measure attitudes about the intervention diet, including desire to adhere, likelihood to adhere in the future, and attitudes about accessibility of sustaining the diet. Items on the FAQ are scored on a scale of 1-7. Higher scores indicate greater food acceptability.
Time frame: 12 weeks
Plan to share: Undecided
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Physicians Committee for Responsible Medicine