Skip to main content
OpenTrials
Completed

NCT Number: NCT00455780

Weight Loss Maintenance in Primary Care

After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI of 30, or BMI of 27 with weight-related comorbidities
  • Access to a telephone and voice mail/answering machine
  • MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)

Exclusion criteria

  • Previously/currently diagnosed with an eating disorder
  • Current bi-polar, depression, substance abuse, or dependence disorder
  • Living with someone already enrolled
  • Enrolled in another weight loss program
  • Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
  • Myocardial infraction within the past three months
  • Unstable angina
  • Nephrotic syndrome/malabsorptive disease
  • Gout attack within the past year
  • Lactating/pregnant (or planning within next two years)
  • Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease

Treatment and study plan

Weight Loss Phase

Behavioral

Weight loss using CBT and meal replacements

Continued CBT

Behavioral

Using CBT during weight loss maintenance

reduced energy density education

Behavioral

Additional nutritional learning

continued use of meal replacements

Behavioral

continued use of meal replacements during weight loss maintenance

Primary outcomes

  1. Weight

    Time frame: baseline, 3 months, 12 months, 24 months, 36 months

Secondary outcomes

  1. Body composition

    Time frame: baseline, 3 months, 12 months, 24 months, 36 months

  2. Blood work results

    Time frame: baseline, 3 months, 12 months, 24 months

  3. Scores on questionnaire-based measures

    Time frame: baseline, 3 months, 12 months, 24 months, 36 months

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PrimaryCare

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Apr 4, 2007
Registry last updated
May 25, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.