Weight Loss Maintenance in Primary Care

NCT ID: NCT00455780

Last Updated: 2011-05-25

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

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR-/REDE-

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.

Group Type EXPERIMENTAL

Weight Loss Phase

Intervention Type BEHAVIORAL

Weight loss using CBT and meal replacements

Continued CBT

Intervention Type BEHAVIORAL

Using CBT during weight loss maintenance

MR+/REDE-

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.

Group Type EXPERIMENTAL

Weight Loss Phase

Intervention Type BEHAVIORAL

Weight loss using CBT and meal replacements

Continued CBT

Intervention Type BEHAVIORAL

Using CBT during weight loss maintenance

continued use of meal replacements

Intervention Type BEHAVIORAL

continued use of meal replacements during weight loss maintenance

MR-/REDE+

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.

Group Type EXPERIMENTAL

Weight Loss Phase

Intervention Type BEHAVIORAL

Weight loss using CBT and meal replacements

Continued CBT

Intervention Type BEHAVIORAL

Using CBT during weight loss maintenance

reduced energy density education

Intervention Type BEHAVIORAL

Additional nutritional learning

MR+/REDE+

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.

Group Type EXPERIMENTAL

Weight Loss Phase

Intervention Type BEHAVIORAL

Weight loss using CBT and meal replacements

Continued CBT

Intervention Type BEHAVIORAL

Using CBT during weight loss maintenance

reduced energy density education

Intervention Type BEHAVIORAL

Additional nutritional learning

continued use of meal replacements

Intervention Type BEHAVIORAL

continued use of meal replacements during weight loss maintenance

Interventions

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Weight Loss Phase

Weight loss using CBT and meal replacements

Intervention Type BEHAVIORAL

Continued CBT

Using CBT during weight loss maintenance

Intervention Type BEHAVIORAL

reduced energy density education

Additional nutritional learning

Intervention Type BEHAVIORAL

continued use of meal replacements

continued use of meal replacements during weight loss maintenance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Drexel University

Principal Investigators

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Michael R Lowe, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

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Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK066759

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK66759 (completed)

Identifier Type: -

Identifier Source: org_study_id

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