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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471172

Enrollment

350

Registered

2007-05-09

Start date

2004-08-31

Completion date

2005-05-31

Last updated

2008-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

Interventions

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

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

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

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

BEHAVIORALSelf help

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage change in body weight at 6 months.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026