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A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

NCT01065974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2017-10-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Behavior Therapy

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

DIETARY_SUPPLEMENT

Meal Replacements

Weight loss using CBT and meal replacements.

BEHAVIORAL

Nutritrol

To make widespread nutritional changes to participants personal food environments.

Sponsors & Collaborators

Principal Investigators

  • Michael R Lowe, Ph.D. · Drexel University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065974 on ClinicalTrials.gov