Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Obesity Clinical Trial

— ENACT  

Official title:

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858714
• Other study ID #: R01DK092374
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: August 3, 2016
• Start date: September 2011
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have a BMI between 27 and 45 kg/m2

• Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)

• Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits

Exclusion Criteria:

• Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss

• Are pregnant or plan to become pregnant in next 2 years

• Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain

• Are participating in or plan to participate in another weight loss program in the next 2 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Behavior Therapy for Weight Loss
Standard behavioral treatment for weight loss and weight loss maintenance.
• Behavior Therapy + Environment
Standard behavioral therapy with an emphasis on environmental strategies.
• Acceptance-based Behavior Therapy + Environment
Behavioral therapy with acceptance-based and environmental strategies.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight		Baseline, 6 months, 12 months, 18 months, 24 months	No
Primary	Change in Physical Activity	Objectively measured physical activity will be recorded at each time point.	Baseline, 6 months, 12 months, 18 months, 24 months	No
Primary	Change in Nutritional Intake	Measured by 24-hour food recall	Baseline, 12 months, 24 months	No
Primary	Change in Psychosocial Status		Baseline, 6 months, 12 months, 18 months, 24 months	No