Impact of an Online Behavioral Weight Loss Program

Baylor College of Medicine

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: online lifestyle counseling and a fortified diet beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT01492413

BI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 572 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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572 participants in 4 patient groups

Online basic lifestyle counseling (OBLI)

Experimental group

Description:

Subjects receive one online informational class.

Treatment:

Behavioral: online lifestyle counseling and a fortified diet beverage

Online lifestyle counseling (OLC)

Experimental group

Description:

Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.

Treatment:

Behavioral: online lifestyle counseling and a fortified diet beverage

OBLI intervention plus a fortified diet beverage (BEV)

Experimental group

Description:

Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.

Treatment:

Behavioral: online lifestyle counseling and a fortified diet beverage

OLC plus fortified diet beverage (BEV)

Experimental group

Description:

Subjects receive OLC plus diet beverage (BEV).

Treatment:

Behavioral: online lifestyle counseling and a fortified diet beverage