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NCT Number: NCT01492413

Impact of an Online Behavioral Weight Loss Program

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRC Human Nutrition Research, Cambridge, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) of 25 to 40;
  • age 18 to 65 years;
  • blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
  • caffeine intake 100-400 mg/d; and
  • ability to participate in physical activity for a minimum of 150 min/week.

Exclusion criteria

  • pregnancy, lactation or actively trying to become pregnant;
  • medical illnesses or medications that could affect body weight;
  • cigarette smokers;
  • weight loss of 10 or more pounds in the last 3 months;
  • fasting blood glucose greater than 126mg/dl;
  • participation in a clinical research study that would conflict with the purpose of the current trial; and
  • other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.

Treatment and study plan

online lifestyle counseling and a fortified diet beverage

Behavioral

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

Primary outcomes

  1. body weight

    Time frame: 12 weeks

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

Secondary outcomes

  1. DEXA-determined fat mass

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • MRC Human Nutrition Research
  • National Development and Research Institutes, Inc.
  • Temple University
  • The Beverage Institute.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2011
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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