Impact of an Online Behavioral Weight Loss Program
This study has been completed.
Sponsor:
Baylor College of Medicine
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
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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:
- 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.
Contacts and Locations
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 Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 19, 2013