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Completed

NCT Number: NCT01065974

A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.

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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 Weight Loss Maintenance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female participants between the ages of 18 and 65
  • body mass index (BMI; kg/m2) between 27-45
  • able to travel regularly to the study location
  • interested in participating in a weight loss program.

Exclusion criteria

  • currently enrolled in another organized weight loss program
  • lactose intolerance
  • taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
  • history of gastric bypass or other surgical weight loss procedures
  • medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
  • pregnancy or planning to become pregnant during the next two years -
  • breastfeeding
  • consuming an amount of alcohol that could interfere with study completion

Treatment and study plan

Behavior Therapy

Behavioral

Weight loss using CBT and continued CBT during weight loss maintenance.

Meal Replacements

Dietary Supplement

Weight loss using CBT and meal replacements.

Nutritrol

Behavioral

To make widespread nutritional changes to participants personal food environments.

Primary outcomes

  1. Change in Body weight over time.

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

    Change in body weight measured on electronic scale.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • University of Pennsylvania

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2010
Registry last updated
Oct 9, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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