Behavioral Treatment for Weight Loss (MYH)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Drexel University

ClinicalTrials.gov Identifier:

NCT00746265

First received: September 2, 2008

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2008
Last Updated Date	May 23, 2012
Start Date ^ICMJE	September 2008
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2008)	BMI change [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00746265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2008)	Change in acceptance-based variables (e.g., mindfulness) [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Behavioral Treatment for Weight Loss
Official Title ^ICMJE	Acceptance-based Behavior Treatment: An Innovative Weight Control
Brief Summary	This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical settings, with acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT) focuses on modifying eating, thinking, and activity levels. Participants limit their daily caloric intake, keep food records, increase physical activity, and practice weight control behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and distinguishing hunger from cravings. The acceptance-based approach (ABT) incorporates the behavioral and nutritional components, but replaced the cognitive and motivational components with components that are consistent with an acceptance-based approach, such as acceptance and willingness to experience cravings, cognitive defusion, mindfulness training to interrupt automatic eating, and values work. These components are drawn from Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999), a cognitive-behavioral therapy that has been gaining increasing attention and empirical support (Bach & Hayes, 2002; Bond & Bunce, 2000; Hayes et al. 2004). Though relatively new, acceptance-based strategies have demonstrated effectiveness in helping individuals to respond to unwanted thoughts and feelings (Hayes, Rissett, Korn, Zettle, Rosenfarb, Cooper, & Grundt, 1999, Keogh, Bond, Hanmer, & Tilston, 2005) and offer a novel alternative to control-based strategies (such as distraction and confrontation). Participants in this study will be randomly assigned to either the traditional behavioral therapy condition (SBT) or the acceptance-based behavioral therapy condition (ABT). Both conditions are delivered in group format. A total of 30, 75 minute sessions will take place over the course of 40 weeks. Specific Aims To evaluate the feasibility and acceptability of the treatment, and its short and moderate-term effectiveness relative to the current gold standard behavioral treatment (SBT). To evaluate the effectiveness of ABT with novice clinicians and with weight control experts. To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional eating, disinhibition or susceptibility to food stimuli.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Overweight and Obesity
Intervention ^ICMJE	Behavioral: Behavioral weight loss intervention Participants in both conditions are provided nutritional education and behavioral strategies for weight loss (consistent with the LEARN program). Participants in SBT are taught the cognitive and motivational strategies used in LEARN while participants in ABT are taught acceptance-based strategies (e.g., acceptance, mindfulness).
Study Arm (s)	Active Comparator: SBT Standard behavioral treatment based on the LEARN manual. Intervention: Behavioral: Behavioral weight loss intervention Active Comparator: ABT Acceptance-based group that is based on the behavioral interventions contained in LEARN manual Intervention: Behavioral: Behavioral weight loss intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	128
Estimated Completion Date	June 2012
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Ages 18 to 65 Fluent in English Body mass index (BMI) of 25 kg/m2 higher Agrees to not join another weight loss program for 9 months Exclusion Criteria: Lactating, pregnant, or planning to become pregnant in the next two years Currently taking a medication or having medical/psychiatric problem known to cause weight loss or weight gain (unless medication is long-term and dosage is unchanging - e.g., Synthroid) A medical or psychiatric condition that limits ability to comply with the program's behavioral recommendations (including physical activity) Current or history in the past ten years of an eating disorder Plans to leave the Philadelphia areas within the next nine months.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00746265
Other Study ID Numbers ^ICMJE	1R21DK080430, 1R21DK080430
Has Data Monitoring Committee	Yes
Responsible Party	Drexel University
Study Sponsor ^ICMJE	Drexel University
Collaborators ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators ^ICMJE	Not Provided
Information Provided By	Drexel University
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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