Cardiovascular Outcomes Of Diet Counseling

Study Overview
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Brief Summary
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(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Detailed Description
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Given the current epidemic of overweight and obesity on a global scale (globesity) and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity. Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Official Title
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Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets

Conditions
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Coronary Artery Disease, Obesity

Intervention / Treatment
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* Behavioral: Medium-intensity Minimally-directive Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: BMI greater than 30, Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Medium-intensity Minimally-directive Counseling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary blood flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  |  | 
| BMI |  |  | 
| LDLc |  |  | 
| Total Cholesterol |  |  | 
| HDLc |  |  | 
| Triglycerides |  |  | 
| Homocysteine |  |  | 
| Fibrinogen |  |  | 
| Lipoprotein (a) |  |  | 
| VLDLc |  |  | 
| TC/HDL |  |  | 
| TG/HDL (Insulin Resistance) |  |  | 
| CRP |  |  | 
| IL-6 |  |  | 
| respiratory quotient |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diets, Heart Disease, Randomized controlled trial, Ischemia.