Clinical trial NCT04222894: Hospital Workplace Nutrition Study
Official title: Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Type2 Diabetes
Keywords: body weight
blood pressure
lipids
nutrition
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
Collaborators: name: Sibley Memorial Hospital
First posted: 2020-01-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: 12 weeks
measure: Plasma Lipids
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Fasting Plasma Glucose
timeFrame: 12 weeks
measure: Absenteeism
timeFrame: 12 weeks
measure: Quality of Life: SF-36
timeFrame: 12 weeks
measure: Dietary Restraint, Disinhibition, Hunger
timeFrame: 12 weeks
measure: Food Acceptability: The Food Acceptability Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: President
name: Neal D Barnard, MD
role: PRINCIPAL_INVESTIGATOR
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