Impact of an Online Behavioral Weight Loss Program

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: online lifestyle counseling and a fortified diet beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom
    • MRC Human Nutrition Research
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Temple University
  • Texas
    • Houston, Texas, United States, 77030
      • Behavioral Medicine Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online basic lifestyle counseling (OBLI); Subjects receive one online informational class.	Behavioral: 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).
Experimental: Online lifestyle counseling (OLC); Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss.	Behavioral: 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).
Experimental: OBLI intervention plus a fortified diet beverage (BEV); Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage.	Behavioral: 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).
Experimental: OLC plus fortified diet beverage (BEV); Subjects receive OLC plus diet beverage (BEV).	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Temple University; National Development and Research Institutes, Inc.; MRC Human Nutrition Research; The Beverage Institute.
• Investigators: Principal Investigator: John P Foreyt, Ph.D., Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Obesity; Overweight
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: BI-001