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

December 13, 2011
December 14, 2011
October 2008
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01492413 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Impact of an Online Behavioral Weight Loss Program
Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
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 basic lifestyle counseling (OBLI)
    Subjects receive one online informational class.
    Intervention: Behavioral: online lifestyle counseling and a fortified diet beverage
  • Experimental: Online lifestyle counseling (OLC)
    Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
    Intervention: Behavioral: online lifestyle counseling and a fortified diet beverage
  • Experimental: OBLI intervention plus a fortified diet beverage (BEV)
    Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
    Intervention: Behavioral: online lifestyle counseling and a fortified diet beverage
  • Experimental: OLC plus fortified diet beverage (BEV)
    Subjects receive OLC plus diet beverage (BEV).
    Intervention: Behavioral: online lifestyle counseling and a fortified diet beverage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
572
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01492413
BI-001
No
John P. Foreyt, Baylor College of Medicine
Baylor College of Medicine
  • The Beverage Institute.
  • Temple University
  • MRC Human Nutrition Research, Cambridge, UK.
  • National Development and Research Institutes, Inc.
Principal Investigator: John P Foreyt, Ph.D. Baylor College of Medicine
Baylor College of Medicine
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP