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Impact of an Online Behavioral Weight Loss Program

This study has been completed.
Sponsor:
Collaborators:
The Beverage Institute.
Temple University
MRC Human Nutrition Research, Cambridge, UK.
National Development and Research Institutes, Inc.
Information provided by (Responsible Party):
John P. Foreyt, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01492413
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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 Intervention
Overweight
Obesity
Behavioral: online lifestyle counseling and a fortified diet beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.


Secondary Outcome Measures:
  • DEXA-determined fat mass [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body fat percent is determined by DEXA using a whole body scanner.


Enrollment: 572
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492413

Locations
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States
United States, Texas
Behavioral Medicine Research Center
Houston, Texas, United States, 77030
United Kingdom
MRC Human Nutrition Research
Cambridge, United Kingdom
Sponsors and Collaborators
Baylor College of Medicine
The Beverage Institute.
Temple University
MRC Human Nutrition Research, Cambridge, UK.
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: John P Foreyt, Ph.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: John P. Foreyt, Professor, Department of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01492413     History of Changes
Other Study ID Numbers: BI-001
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Overweight
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014