Hospital Workplace Nutrition Study

Not Applicable

Completed

• Conditions: Overweight; Type2 Diabetes
• Interventions: Other: Plant-based diet; Other: Control Diet

• Registration Number: NCT04222894
• Lead Sponsor: Physicians Committee for Responsible Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-06-26
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Employee of Sibley hospital
2. Male or female
3. Age at least 18 years
4. Have a BMI >25 kg/m2
5. Ability and willingness to participate in all components of the study
6. A willingness to follow a plant-based diet for the duration of the study
7. A willingness to attend weekly classes for the duration of the study
8. A willingness to keep physical activity level consistent throughout the duration of the study

Exclusion Criteria

1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
2. Smoking during the past six months
3. 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
4. Current or unresolved past drug abuse
5. Pregnancy or plans to become pregnant in the next 12 weeks
6. Intention to leave hospital employment in the next 12 weeks
7. Unstable medical or psychiatric status
8. Evidence of an eating disorder
9. Lack of English fluency
10. Inability to maintain current medication regimen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant-based diet	Plant-based diet	The diet group will be asked to follow a low-fat, vegan diet for 12 weeks
Control diet	Control Diet	Half of the participants will be asked to continue their usual diets for the 12-week study period.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	12 weeks	HbA1c will be measured as an index of glycemic control.
Fasting Plasma Glucose	12 weeks	Fasting Plasma Glucose will be measured as an index of glycemic control.
Quality of Life: SF-36	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.
Absenteeism	12 weeks	Absenteeism from work will be assessed by self-report at baseline and final assessments.
Dietary Restraint, Disinhibition, Hunger	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.
Food Acceptability: The Food Acceptability Questionnaire	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.

Trial Locations

Locations (1)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States