Study to Promote Weight Loss in Primary Care Practices

Study Overview
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Brief Summary
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The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

Detailed Description
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Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.

Official Title
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Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Individual telephone intervention
* Behavioral: Group telephone intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese Metabolic syndrome Read and write English Planning to stay in treatment with their PCP for the next 3 years On stable doses of medications for chronic diseases such as hypothyroidism for 3 years Exclusion Criteria: Unstable health Diabetes mellitus Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Telephone Intervention<br>Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. | Behavioral: Individual telephone intervention<br>* Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.<br>|
| Active Comparator: Group Telephone Intervention<br>Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. | Behavioral: Group telephone intervention<br>* Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight (kg) | baseline, 1, 2, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg) | baseline, 1, 2, 3 years | 
| Fasting Lipid Panel | LDL-cholesterol (mg/dL) | baseline, 1, 2, 3 years | 
| Fasting Glucose Level | Fasting glucose (mg/dL) | baseline, 1, 2, 3 years | 
| Health Behaviors (Diet, Physical Activity) | National Cancer Institute Fat screener | baseline, 6 months, 1 and 2 years | 
| SF-12 Physical Summary Score | The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health). | baseline, 6 months, 1 and 2 years | 
| International Physical Activity Questionnaire | Measure of physical activity is calculated as in mets/week | baseline, 6 months, 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Metabolic syndrome, Weight loss, Diabetes prevention