Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
NCT Number: NCT04222894
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20016, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Other names: Vegan diet
Participants will be asked to continue their usual diets for the 12-week study period.
Time frame: 12 weeks
Anticipated weight-loss for intervention group compared with control group
Time frame: 12 weeks
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Time frame: 12 weeks
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
Time frame: 12 weeks
HbA1c will be measured as an index of glycemic control.
Time frame: 12 weeks
Fasting Plasma Glucose will be measured as an index of glycemic control.
Time frame: 12 weeks
Absenteeism from work will be assessed by self-report at baseline and final assessments.
Time frame: 12 weeks
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
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
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.
Physicians Committee for Responsible Medicine
Other
Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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