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A Nutritional Intervention in Police Officers

Primary Purpose

Overweight, Blood Pressure, Diabetes Mellitus, Type 2

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Plant-based diet

Control Group

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life, Glycemic Index

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women at least 18 years
Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes
Currently an employee of the Metropolitan Police Department of the District of Columbia
Ability and willingness to participate in all components of the study
A willingness to be randomly assigned to either study group

Exclusion Criteria:

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
Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
Pregnancy
Unstable medical or psychiatric illness
Likely to be disruptive in group sessions (as determined by research staff)
Already following a low-fat, vegan diet
Lack of English fluency
Inability or unwillingness to participate in all components of the study

Sites / Locations

Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vegan Group

Control Group

Arm Description

Participants in the intervention group will follow a low-fat, plant-based diet for 14 weeks, and will attend nutrition classes in the form of a weekly support group.

The control group will follow an unrestricted diet with no instruction.

Outcomes

Primary Outcome Measures

Body Weight

body weight will be measured to the nearest 0.1 kg, using a digital scale.

Plasma lipid concentrations

will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations.

Blood pressure

Blood pressure will be measured at each assessment

Secondary Outcome Measures

Quality of Life and Mood

Measured by a Modified Health Assessment Questionnaire (MHAQ). The questionnaire measures the difficulty level of performing 8 different activities. A score of 0 = the activity can be performed without difficulty. A score of 3 = the activity cannot be performed. The MHAQ is calculated as the average of these scores.

Full Information

NCT ID

NCT02651480

First Posted

January 7, 2016

Last Updated

September 27, 2022

Sponsor

Physicians Committee for Responsible Medicine

Collaborators

Metropolitan Police Department of Washington, D.C.

1. Study Identification

Unique Protocol Identification Number

NCT02651480

Brief Title

A Nutritional Intervention in Police Officers

Official Title

A Nutritional Intervention in Police Officers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Suspended

Why Stopped

Sponsor put plans on hold

Study Start Date

February 2016 (undefined)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Physicians Committee for Responsible Medicine

Collaborators

Metropolitan Police Department of Washington, D.C.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

Detailed Description

This study tests the hypotheses that a low-fat, plant-based (vegan) diet improves body weight, plasma lipid concentrations, blood pressure, and, in individuals with type 2 diabetes, glycemic control, that a low-fat, plant-based diet improves health-related quality of life as measured by the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36), and that a low-fat, plant-based diet improves mood, as measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Blood Pressure, Diabetes Mellitus, Type 2

Keywords

Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life, Glycemic Index

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vegan Group

Arm Type

Experimental

Arm Description

Participants in the intervention group will follow a low-fat, plant-based diet for 14 weeks, and will attend nutrition classes in the form of a weekly support group.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

The control group will follow an unrestricted diet with no instruction.

Intervention Type

Dietary Supplement

Intervention Name(s)

Plant-based diet

Other Intervention Name(s)

Vegan Group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Control Group

Other Intervention Name(s)

Control

Intervention Description

Unrestricted diet with no instruction.

Primary Outcome Measure Information:

Title

Body Weight

Description

body weight will be measured to the nearest 0.1 kg, using a digital scale.

Time Frame

Changes in body weight from Baseline at 14 weeks

Title

Plasma lipid concentrations

Description

will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations.

Time Frame

Changes in plasma lipid concentrations from Baseline at 14 weeks

Title

Blood pressure

Description

Blood pressure will be measured at each assessment

Time Frame

Changes in blood pressure from Baseline at 14 weeks

Secondary Outcome Measure Information:

Title

Quality of Life and Mood

Description

Time Frame

Change in quality of life from Baseline at 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women at least 18 years Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes Currently an employee of the Metropolitan Police Department of the District of Columbia Ability and willingness to participate in all components of the study A willingness to be randomly assigned to either study group Exclusion Criteria: 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 Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) Pregnancy Unstable medical or psychiatric illness Likely to be disruptive in group sessions (as determined by research staff) Already following a low-fat, vegan diet Lack of English fluency Inability or unwillingness to participate in all components of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal D Barnard, M.D.

Organizational Affiliation

President

Official's Role

Principal Investigator

Facility Information:

Facility Name

Physicians Committee for Responsible Medicine

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

12. IPD Sharing Statement

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A Nutritional Intervention in Police Officers

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