An interventional study of online lifestyle counseling and a fortified diet beverage in Overweight and Obesity, sponsored by Baylor College of Medicine. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-15.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
3,671 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's enrollment of 572 is above the median of 74 across 3,176 interventional studies indexed under Overweight.
Browse Overweight studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
Subjects receive one online informational class.
Behavioral: online lifestyle counseling and a fortified diet beverage
Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.
Behavioral: online lifestyle counseling and a fortified diet beverage
Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.
Behavioral: online lifestyle counseling and a fortified diet beverage
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).
body weight
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
Time frame: 12 weeks
DEXA-determined fat mass
Body fat percent is determined by DEXA using a whole body scanner.
Time frame: 12 weeks
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine