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Hospital Workplace Nutrition Study

Primary Purpose

Overweight, Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant-based diet
Control Diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring body weight, blood pressure, lipids, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sibley Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plant-based diet

Control diet

Arm Description

The diet group will be asked to follow a low-fat, vegan diet for 12 weeks

Half of the participants will be asked to continue their usual diets for the 12-week study period.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin A1c
HbA1c will be measured as an index of glycemic control.
Fasting Plasma Glucose
Fasting Plasma Glucose will be measured as an index of glycemic control.
Absenteeism
Absenteeism from work will be assessed by self-report at baseline and final assessments.
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.
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.
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.

Full Information

First Posted
January 7, 2020
Last Updated
April 18, 2022
Sponsor
Physicians Committee for Responsible Medicine
Collaborators
Sibley Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04222894
Brief Title
Hospital Workplace Nutrition Study
Official Title
Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine
Collaborators
Sibley Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Type2 Diabetes
Keywords
body weight, blood pressure, lipids, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plant-based diet
Arm Type
Active Comparator
Arm Description
The diet group will be asked to follow a low-fat, vegan diet for 12 weeks
Arm Title
Control diet
Arm Type
Active Comparator
Arm Description
Half of the participants will be asked to continue their usual diets for the 12-week study period.
Intervention Type
Other
Intervention Name(s)
Plant-based diet
Other Intervention Name(s)
Vegan diet
Intervention Description
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Intervention Type
Other
Intervention Name(s)
Control Diet
Intervention Description
Participants will be asked to continue their usual diets for the 12-week study period.
Primary Outcome Measure Information:
Title
Body Weight
Description
Anticipated weight-loss for intervention group compared with control group
Time Frame
12 weeks
Title
Blood Pressure
Description
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Time Frame
12 weeks
Title
Plasma Lipids
Description
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
HbA1c will be measured as an index of glycemic control.
Time Frame
12 weeks
Title
Fasting Plasma Glucose
Description
Fasting Plasma Glucose will be measured as an index of glycemic control.
Time Frame
12 weeks
Title
Absenteeism
Description
Absenteeism from work will be assessed by self-report at baseline and final assessments.
Time Frame
12 weeks
Title
Quality of Life: SF-36
Description
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
Title
Dietary Restraint, Disinhibition, Hunger
Description
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
Title
Food Acceptability: The Food Acceptability Questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal D Barnard, MD
Organizational Affiliation
President
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Hospital Workplace Nutrition Study

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