Impact of an Online Behavioral Weight Loss Program

Baylor College of Medicine572 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

572

Conditions

Overweight Obesity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Temple University

Philadelphia, Pennsylvania, United States

Behavioral Medicine Research Center

Houston, Texas, United States

MRC Human Nutrition Research

Cambridge, United Kingdom

Outcomes

Primary Outcomes

body weight

Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.

Time frame: 12 weeks

Secondary Outcomes

DEXA-determined fat mass

Body fat percent is determined by DEXA using a whole body scanner.