Back to resultsImpact of an Online Behavioral Weight Loss Program
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
online lifestyle counseling and a fortified diet beverage
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) of 25 to 40;
- age 18 to 65 years;
- blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
- caffeine intake 100-400 mg/d; and
- ability to participate in physical activity for a minimum of 150 min/week.
Exclusion Criteria:
- pregnancy, lactation or actively trying to become pregnant;
- medical illnesses or medications that could affect body weight;
- cigarette smokers;
- weight loss of 10 or more pounds in the last 3 months;
- fasting blood glucose greater than 126mg/dl;
- participation in a clinical research study that would conflict with the purpose of the current trial; and
- other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
Sites / Locations
- Temple University
- Behavioral Medicine Research Center
- MRC Human Nutrition Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Online basic lifestyle counseling (OBLI)
Online lifestyle counseling (OLC)
OBLI intervention plus a fortified diet beverage (BEV)
OLC plus fortified diet beverage (BEV)
Arm Description
Subjects receive one online informational class.
Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
Subjects receive OLC plus diet beverage (BEV).
Outcomes
Primary Outcome Measures
body weight
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
Body fat percent is determined by DEXA using a whole body scanner.
Full Information
NCT ID
NCT01492413
First Posted
December 13, 2011
Last Updated
December 14, 2011
Sponsor
Baylor College of Medicine
Collaborators
The Beverage Institute., Temple University, MRC Human Nutrition Research, National Development and Research Institutes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01492413
Brief Title
Impact of an Online Behavioral Weight Loss Program
Official Title
Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
The Beverage Institute., Temple University, MRC Human Nutrition Research, National Development and Research Institutes, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
572 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online basic lifestyle counseling (OBLI)
Arm Type
Experimental
Arm Description
Subjects receive one online informational class.
Arm Title
Online lifestyle counseling (OLC)
Arm Type
Experimental
Arm Description
Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
Arm Title
OBLI intervention plus a fortified diet beverage (BEV)
Arm Type
Experimental
Arm Description
Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
Arm Title
OLC plus fortified diet beverage (BEV)
Arm Type
Experimental
Arm Description
Subjects receive OLC plus diet beverage (BEV).
Intervention Type
Behavioral
Intervention Name(s)
online lifestyle counseling and a fortified diet beverage
Intervention Description
The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).
Primary Outcome Measure Information:
Title
body weight
Description
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
DEXA-determined fat mass
Description
Body fat percent is determined by DEXA using a whole body scanner.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body Mass Index (BMI) of 25 to 40;
age 18 to 65 years;
blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
caffeine intake 100-400 mg/d; and
ability to participate in physical activity for a minimum of 150 min/week.
Exclusion Criteria:
pregnancy, lactation or actively trying to become pregnant;
medical illnesses or medications that could affect body weight;
cigarette smokers;
weight loss of 10 or more pounds in the last 3 months;
fasting blood glucose greater than 126mg/dl;
participation in a clinical research study that would conflict with the purpose of the current trial; and
other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Foreyt, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Behavioral Medicine Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MRC Human Nutrition Research
City
Cambridge
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Impact of an Online Behavioral Weight Loss Program
We'll reach out to this number within 24 hrs