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Weight Loss Maintenance in Primary Care (PrimaryCare)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Phase
Continued CBT
reduced energy density education
continued use of meal replacements
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

MR-/REDE-

MR+/REDE-

MR-/REDE+

MR+/REDE+

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Body composition
Blood work results
Scores on questionnaire-based measures

Full Information

First Posted
April 3, 2007
Last Updated
May 24, 2011
Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00455780
Brief Title
Weight Loss Maintenance in Primary Care
Acronym
PrimaryCare
Official Title
Weight Loss Maintenance in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR-/REDE-
Arm Type
Experimental
Arm Description
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
Arm Title
MR+/REDE-
Arm Type
Experimental
Arm Description
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
Arm Title
MR-/REDE+
Arm Type
Experimental
Arm Description
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
Arm Title
MR+/REDE+
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Phase
Intervention Description
Weight loss using CBT and meal replacements
Intervention Type
Behavioral
Intervention Name(s)
Continued CBT
Intervention Description
Using CBT during weight loss maintenance
Intervention Type
Behavioral
Intervention Name(s)
reduced energy density education
Intervention Description
Additional nutritional learning
Intervention Type
Behavioral
Intervention Name(s)
continued use of meal replacements
Intervention Description
continued use of meal replacements during weight loss maintenance
Primary Outcome Measure Information:
Title
Weight
Time Frame
baseline, 3 months, 12 months, 24 months, 36 months
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
baseline, 3 months, 12 months, 24 months, 36 months
Title
Blood work results
Time Frame
baseline, 3 months, 12 months, 24 months
Title
Scores on questionnaire-based measures
Time Frame
baseline, 3 months, 12 months, 24 months, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Lowe, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

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Weight Loss Maintenance in Primary Care

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