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Impact of an Online Behavioral Weight Loss Program

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01492413
Collaborator
The Beverage Institute. (Other), Temple University (Other), MRC Human Nutrition Research (Other), National Development and Research Institutes, Inc. (Other)
572
Enrollment
3
Locations
4
Arms
38
Duration (Months)
190.7
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: online lifestyle counseling and a fortified diet beverage
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
572 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Online basic lifestyle counseling (OBLI)

Subjects receive one online informational class.

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).
Experimental: Online lifestyle counseling (OLC)

Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.

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).
Experimental: OBLI intervention plus a fortified diet beverage (BEV)

Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.

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).
Experimental: OLC plus fortified diet beverage (BEV)

Subjects receive OLC plus diet beverage (BEV).

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. DEXA-determined fat mass [12 weeks]

    Body fat percent is determined by DEXA using a whole body scanner.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Temple University Philadelphia Pennsylvania United States
2 Behavioral Medicine Research Center Houston Texas United States 77030
3 MRC Human Nutrition Research Cambridge United Kingdom

Sponsors and Collaborators

  • Baylor College of Medicine
  • The Beverage Institute.
  • Temple University
  • MRC Human Nutrition Research
  • National Development and Research Institutes, Inc.

Investigators

  • Principal Investigator: John P Foreyt, Ph.D., Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John P. Foreyt, Professor, Department of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01492413
Other Study ID Numbers:
  • BI-001
First Posted:
Dec 15, 2011
Last Update Posted:
Dec 15, 2011
Last Verified:
Dec 1, 2011
Keywords provided by John P. Foreyt, Professor, Department of Medicine, Baylor College of Medicine
Overweight
Obesity
Additional relevant MeSH terms:
Overweight
Weight Loss

Study Results

No Results Posted as of Dec 15, 2011