Impact of an Online Behavioral Weight Loss Program

Obesity Clinical Trial

Official title:

Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492413
• Other study ID #: BI-001
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: December 14, 2011
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• online lifestyle counseling and a fortified diet beverage
The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).

Locations

Country	Name	City	State
United Kingdom	MRC Human Nutrition Research	Cambridge
United States	Behavioral Medicine Research Center	Houston	Texas
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Baylor College of Medicine	MRC Human Nutrition Research, Cambridge, UK., National Development and Research Institutes, Inc., Temple University, The Beverage Institute.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.	12 weeks	No
Secondary	DEXA-determined fat mass	Body fat percent is determined by DEXA using a whole body scanner.	12 weeks	No