Clinical trial NCT01492413: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: The Beverage Institute.
name: Temple University
name: MRC Human Nutrition Research
name: National Development and Research Institutes, Inc.
First posted: 2011-12-15
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: body weight
timeFrame: 12 weeks
Secondary outcomes:
measure: DEXA-determined fat mass
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Houston
country: United States
facility: Behavioral Medicine Research Center
state: Texas
city: Cambridge
country: United Kingdom
facility: MRC Human Nutrition Research
Study officials:
affiliation: Baylor College of Medicine
name: John P Foreyt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: