Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss

Study Overview
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Brief Summary
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The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.

Official Title
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A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)
* Behavioral: Face-to-face counseling by a dietitian (monthly)
* Behavioral: Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)
* Behavioral: Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)
* Behavioral: Self help


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2. 2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert 3- Willingness and ability to comply with study related procedures 4- Access to Internet and email Exclusion Criteria: Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)|nan|
|Behavioral: Face-to-face counseling by a dietitian (monthly)|nan|
|Behavioral: Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)|nan|
|Behavioral: Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)|nan|
|Behavioral: Self help|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in body weight at 6 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months. |  |  |