Hospital Workplace Nutrition Study

April 18, 2022 updated by: Physicians Committee for Responsible Medicine

Hospital Workplace Nutrition Study (Sibley Memorial Hospital)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 12 weeks
Anticipated weight-loss for intervention group compared with control group
12 weeks
Blood Pressure
Time Frame: 12 weeks
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
12 weeks
Plasma Lipids
Time Frame: 12 weeks
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
Time Frame: 12 weeks
HbA1c will be measured as an index of glycemic control.
12 weeks
Fasting Plasma Glucose
Time Frame: 12 weeks
Fasting Plasma Glucose will be measured as an index of glycemic control.
12 weeks
Absenteeism
Time Frame: 12 weeks
Absenteeism from work will be assessed by self-report at baseline and final assessments.
12 weeks
Quality of Life: SF-36
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.
12 weeks
Dietary Restraint, Disinhibition, Hunger
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.
12 weeks
Food Acceptability: The Food Acceptability Questionnaire
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physicians Committee for Responsible Medicine

Collaborators

Sibley Memorial Hospital

Investigators

  • Principal Investigator: Neal D Barnard, MD, President

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2020

Primary Completion (ACTUAL)

September 30, 2021

Study Completion (ACTUAL)

September 30, 2021

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (ACTUAL)

January 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00038823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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