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Completed

NCT Number: NCT04222894

Hospital Workplace Nutrition Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-Based Diet

Other

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Other names: Vegan diet

Control diet

Other

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

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

    Anticipated weight-loss for intervention group compared with control group

  2. Blood Pressure

    Time frame: 12 weeks

    Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group

  3. Plasma Lipids

    Time frame: 12 weeks

    Anticipated changes in plasma lipid concentrations for intervention group compared with control group

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 12 weeks

    HbA1c will be measured as an index of glycemic control.

  2. Fasting Plasma Glucose

    Time frame: 12 weeks

    Fasting Plasma Glucose will be measured as an index of glycemic control.

  3. Absenteeism

    Time frame: 12 weeks

    Absenteeism from work will be assessed by self-report at baseline and final assessments.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Collaborators

  • Sibley Memorial Hospital

Registry information

Official study title

Hospital Workplace Nutrition Study (Sibley Memorial Hospital)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2020
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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