A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

Obesity Clinical Trial

Official title:

A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065974
• Other study ID #: 5R01DK80909-2
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: October 5, 2017
• Start date: October 2009
• Est. completion date: April 30, 2016

Study information

• Verified date: October 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss
• Weight Loss Maintenance

Intervention

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.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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