A Nutritional Intervention in Police Officers

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

Detailed Description
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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).

Official Title
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A Nutritional Intervention in Police Officers

Conditions
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Overweight, Blood Pressure, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Plant-based diet
* Dietary Supplement: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan Group<br>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. | Dietary Supplement: Plant-based diet<br>* Weekly instructions will be given to the participants in the intervention group about following vegan diet.<br>* Other names: Vegan Group;|
| Active Comparator: Control Group<br>The control group will follow an unrestricted diet with no instruction. | Dietary Supplement: Control Group<br>* Unrestricted diet with no instruction.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | body weight will be measured to the nearest 0.1 kg, using a digital scale. | Changes in body weight from Baseline at 14 weeks | 
| Plasma lipid concentrations | will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations. | Changes in plasma lipid concentrations from Baseline at 14 weeks | 
| Blood pressure | Blood pressure will be measured at each assessment | Changes in blood pressure from Baseline at 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change in quality of life from Baseline at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life