NCT01065974

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

6.6 years

First QC Date

February 8, 2010

Last Update Submit

October 5, 2017

Conditions

OverweightObesityWeight Loss Maintenance

Keywords

Nutritional IntakePsychosocial Outcome

Outcome Measures

Primary Outcomes (1)

  • Change in Body weight over time.

    Change in body weight measured on electronic scale.

    Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Study Arms (3)

Behavior Therapy

ACTIVE COMPARATOR

Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below: * Self monitoring * Stimulus control * Changing eating behaviors * Goal setting * Problem solving * Social support * Cognitive restructuring * Relapse prevention

Behavioral: Behavior Therapy

Behavior Therapy + Meal Replacements

EXPERIMENTAL

The BT +MR condition will implement behavioral treatment strategies in a way that is nearly identical to that of the BT condition. However, participants in this condition also will use MRs during weight loss and weight loss maintenance.

Dietary Supplement: Meal Replacements

Nutritrol

EXPERIMENTAL

Participants in this condition will be informed about the evidence indicating that the availability, structure and composition of foods they encounter or seek out in their daily lives will play a major role in determining their ability to maintain the weight they lose. We will present the treatment as an opportunity to make numerous changes to their "personal food environment" involving the variety, energy density, nutritional composition, and portion size of the foods they encounter in every day life. The Nutritrol condition is comprised of several components: * Food structure * Energy density * Reduce variety of foods high in energy density and increase variety of foods low in energy density * Protein intake * Controlling the personal food environment * Individualized weight loss maintenance prescriptions

Behavioral: Nutritrol

Interventions

Behavior TherapyBEHAVIORAL

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

Behavior Therapy
Meal ReplacementsDIETARY_SUPPLEMENT

Weight loss using CBT and meal replacements.

Behavior Therapy + Meal Replacements
NutritrolBEHAVIORAL

To make widespread nutritional changes to participants personal food environments.

Nutritrol

Eligibility Criteria

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

You may qualify if:

  • Male and female participants between the ages of 18 and 65
  • body mass index (BMI; kg/m2) between 27-45
  • able to travel regularly to the study location
  • interested in participating in a weight loss program.

You may not qualify if:

  • currently enrolled in another organized weight loss program
  • lactose intolerance
  • taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
  • history of gastric bypass or other surgical weight loss procedures
  • medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
  • pregnancy or planning to become pregnant during the next two years -
  • breastfeeding
  • consuming an amount of alcohol that could interfere with study completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. 2018 Jan 1;107(1):12-19. doi: 10.1093/ajcn/nqx005.

    PMID: 29381791DERIVED

  • Feig EH, Lowe MR. Variability in Weight Change Early in Behavioral Weight Loss Treatment: Theoretical and Clinical Implications. Obesity (Silver Spring). 2017 Sep;25(9):1509-1515. doi: 10.1002/oby.21925.

    PMID: 28845608DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael R Lowe, Ph.D.

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 10, 2010

Study Start

October 1, 2009

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

US(2)