Impact of an Online Behavioral Weight Loss Program

NCT ID: NCT01492413

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Keywords

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online basic lifestyle counseling (OBLI)

Subjects receive one online informational class.

Group Type EXPERIMENTAL

online lifestyle counseling and a fortified diet beverage

Intervention Type BEHAVIORAL

The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).

Online lifestyle counseling (OLC)

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

Group Type EXPERIMENTAL

online lifestyle counseling and a fortified diet beverage

Intervention Type BEHAVIORAL

The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).

OBLI intervention plus a fortified diet beverage (BEV)

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

Group Type EXPERIMENTAL

online lifestyle counseling and a fortified diet beverage

Intervention Type BEHAVIORAL

The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).

OLC plus fortified diet beverage (BEV)

Subjects receive OLC plus diet beverage (BEV).

Group Type EXPERIMENTAL

online lifestyle counseling and a fortified diet beverage

Intervention Type BEHAVIORAL

The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Beverage Institute.

UNKNOWN

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role collaborator

MRC Human Nutrition Research

OTHER_GOV

Sponsor Role collaborator

National Development and Research Institutes, Inc.

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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John P. Foreyt

Professor, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John P Foreyt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status

Behavioral Medicine Research Center

Houston, Texas, United States

Site Status

MRC Human Nutrition Research

Cambridge, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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BI-001

Identifier Type: -

Identifier Source: org_study_id