Impact of an Online Behavioral Weight Loss Program
1 other identifier
interventional
572
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedDecember 15, 2011
December 1, 2011
3.2 years
December 13, 2011
December 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body weight
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
12 weeks
Secondary Outcomes (1)
DEXA-determined fat mass
12 weeks
Study Arms (4)
Online basic lifestyle counseling (OBLI)
EXPERIMENTALSubjects receive one online informational class.
Online lifestyle counseling (OLC)
EXPERIMENTALSubjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
OBLI intervention plus a fortified diet beverage (BEV)
EXPERIMENTALSubjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
OLC plus fortified diet beverage (BEV)
EXPERIMENTALSubjects receive OLC plus diet beverage (BEV).
Interventions
The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- The Beverage Institute.collaborator
- Temple Universitycollaborator
- MRC Human Nutrition Researchcollaborator
- National Development and Research Institutes, Inc.collaborator
Study Sites (3)
Temple University
Philadelphia, Pennsylvania, United States
Behavioral Medicine Research Center
Houston, Texas, 77030, United States
MRC Human Nutrition Research
Cambridge, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Foreyt, Ph.D.
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Medicine
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 15, 2011
Record last verified: 2011-12