Study to Promote Weight Loss in Primary Care Practices

Not Applicable

Completed

Interventions: Behavioral: Individual telephone intervention
Behavioral: Group telephone intervention

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Individual Telephone Intervention	Individual telephone intervention	Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Group Telephone Intervention	Group telephone intervention	Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.

Primary Outcome Measures

Name	Time	Method
Weight	baseline, 1, 2, 3 years	Weight (kg)

Secondary Outcome Measures

Name	Time	Method
Fasting Lipid Panel	baseline, 1, 2, 3 years	LDL-cholesterol (mg/dL)
Blood Pressure	baseline, 1, 2, 3 years	Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
SF-12 Physical Summary Score	baseline, 6 months, 1 and 2 years	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).
Fasting Glucose Level	baseline, 1, 2, 3 years	Fasting glucose (mg/dL)
Health Behaviors (Diet, Physical Activity)	baseline, 6 months, 1 and 2 years	National Cancer Institute Fat screener
International Physical Activity Questionnaire	baseline, 6 months, 1 and 2 years	Measure of physical activity is calculated as in mets/week