Clinical trial NCT01858714: Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
Official title: Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Keywords: obesity
overweight
weight loss
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change in Physical Activity
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Change in Nutritional Intake
timeFrame: Baseline, 12 months, 24 months
measure: Change in Psychosocial Status
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References:
citation: Butryn ML, Call CC, Schumacher LM, Kerrigan SG, Forman EM. Time to Peak Weight Loss During Extended Behavioral Treatment. Obesity (Silver Spring). 2018 Apr;26(4):658-664. doi: 10.1002/oby.22127. Epub 2018 Feb 14.
citation: Butryn ML, Forman EM, Lowe MR, Gorin AA, Zhang F, Schaumberg K. Efficacy of environmental and acceptance-based enhancements to behavioral weight loss treatment: The ENACT trial. Obesity (Silver Spring). 2017 May;25(5):866-872. doi: 10.1002/oby.21813. Epub 2017 Mar 23.
citation: Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.