NCT00455780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

5.6 years

First QC Date

April 3, 2007

Last Update Submit

May 24, 2011

Conditions

ObesityOverweight

Keywords

EatingDietingMeal replacementsEnergy DensityWeight Loss Maintenance

Outcome Measures

Primary Outcomes (1)

  • Weight

    baseline, 3 months, 12 months, 24 months, 36 months

Secondary Outcomes (3)

  • Body composition

    baseline, 3 months, 12 months, 24 months, 36 months

  • Blood work results

    baseline, 3 months, 12 months, 24 months

  • Scores on questionnaire-based measures

    baseline, 3 months, 12 months, 24 months, 36 months

Study Arms (4)

MR-/REDE-

EXPERIMENTAL

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

Behavioral: Weight Loss PhaseBehavioral: Continued CBT

MR+/REDE-

EXPERIMENTAL

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

Behavioral: Weight Loss PhaseBehavioral: Continued CBTBehavioral: continued use of meal replacements

MR-/REDE+

EXPERIMENTAL

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

Behavioral: Weight Loss PhaseBehavioral: Continued CBTBehavioral: reduced energy density education

MR+/REDE+

EXPERIMENTAL

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.

Behavioral: Weight Loss PhaseBehavioral: Continued CBTBehavioral: reduced energy density educationBehavioral: continued use of meal replacements

Interventions

Weight Loss PhaseBEHAVIORAL

Weight loss using CBT and meal replacements

MR+/REDE+MR+/REDE-MR-/REDE+MR-/REDE-
Continued CBTBEHAVIORAL

Using CBT during weight loss maintenance

MR+/REDE+MR+/REDE-MR-/REDE+MR-/REDE-
reduced energy density educationBEHAVIORAL

Additional nutritional learning

MR+/REDE+MR-/REDE+
continued use of meal replacementsBEHAVIORAL

continued use of meal replacements during weight loss maintenance

MR+/REDE+MR+/REDE-

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R Lowe, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

January 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations

US(1)