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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-05-31

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)

Intervention Type BEHAVIORAL

Face-to-face counseling by a dietitian (monthly)

Intervention Type BEHAVIORAL

Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)

Intervention Type BEHAVIORAL

Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)

Intervention Type BEHAVIORAL

Self help

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No