Hospital Workplace Nutrition Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hospital Workplace Nutrition Study (Sibley Memorial Hospital)

Conditions
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Overweight, Type2 Diabetes

Intervention / Treatment
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* Other: Plant-based diet
* Other: Control Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Employee of Sibley hospital Male or female Age at least 18 years Have a BMI >25 kg/m2 Ability and willingness to participate in all components of the study A willingness to follow a plant-based diet for the duration of the study A willingness to attend weekly classes for the duration of the study A willingness to keep physical activity level consistent throughout the duration of the study Exclusion Criteria: Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome Smoking during the past six months Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use Current or unresolved past drug abuse Pregnancy or plans to become pregnant in the next 12 weeks Intention to leave hospital employment in the next 12 weeks Unstable medical or psychiatric status Evidence of an eating disorder Lack of English fluency Inability to maintain current medication regimen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant-based diet<br>The diet group will be asked to follow a low-fat, vegan diet for 12 weeks | Other: Plant-based diet<br>* Weekly instructions will be given to the participants in the intervention group about following vegan diet.<br>* Other names: Vegan diet;|
| Active Comparator: Control diet<br>Half of the participants will be asked to continue their usual diets for the 12-week study period. | Other: Control Diet<br>* Participants will be asked to continue their usual diets for the 12-week study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Anticipated weight-loss for intervention group compared with control group | 12 weeks | 
| Blood Pressure | Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group | 12 weeks | 
| Plasma Lipids | Anticipated changes in plasma lipid concentrations for intervention group compared with control group | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | HbA1c will be measured as an index of glycemic control. | 12 weeks | 
| Fasting Plasma Glucose | Fasting Plasma Glucose will be measured as an index of glycemic control. | 12 weeks | 
| Absenteeism | Absenteeism from work will be assessed by self-report at baseline and final assessments. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body weight, blood pressure, lipids, nutrition