Impact of an Online Behavioral Weight Loss Program

Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01492413

Enrollment

572

Registered

2011-12-15

Start date

2008-10-31

Completion date

2011-12-31

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Overweight, Obesity

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.

Interventions

BEHAVIORALonline 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
body weight	12 weeks	Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.

Secondary

Measure	Time frame	Description
DEXA-determined fat mass	12 weeks	Body fat percent is determined by DEXA using a whole body scanner.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026