Impact of an Online Behavioral Weight Loss Program

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: online lifestyle counseling and a fortified diet beverage

• Registration Number: NCT01492413
• Lead Sponsor: Baylor College of Medicine

Brief Summary

This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.

Detailed Description

This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Last Update Submitted: 2011-12-14
• Study First Posted: 2011-12-15
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 572

Inclusion Criteria

1. Body Mass Index (BMI) of 25 to 40;
2. age 18 to 65 years;
3. blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
4. caffeine intake 100-400 mg/d; and
5. ability to participate in physical activity for a minimum of 150 min/week.

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Exclusion Criteria

1. pregnancy, lactation or actively trying to become pregnant;
2. medical illnesses or medications that could affect body weight;
3. cigarette smokers;
4. weight loss of 10 or more pounds in the last 3 months;
5. fasting blood glucose greater than 126mg/dl;
6. participation in a clinical research study that would conflict with the purpose of the current trial; and
7. other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online basic lifestyle counseling (OBLI)	online lifestyle counseling and a fortified diet beverage	Subjects receive one online informational class.
Online lifestyle counseling (OLC)	online lifestyle counseling and a fortified diet beverage	Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
OBLI intervention plus a fortified diet beverage (BEV)	online lifestyle counseling and a fortified diet beverage	Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
OLC plus fortified diet beverage (BEV)	online lifestyle counseling and a fortified diet beverage	Subjects receive OLC plus diet beverage (BEV).

Primary Outcome Measures

Name	Time	Method
body weight	12 weeks	Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.

Secondary Outcome Measures

Name	Time	Method
DEXA-determined fat mass	12 weeks	Body fat percent is determined by DEXA using a whole body scanner.

Trial Locations

Locations (3)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Behavioral Medicine Research Center; 🇺🇸 Houston, Texas, United States

MRC Human Nutrition Research; 🇬🇧 Cambridge, United Kingdom