Behavioral Treatment for Weight Loss (MYH)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Overweight and Obesity |
Behavioral: Behavioral weight loss intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Acceptance-based Behavior Treatment: An Innovative Weight Control |
- BMI change [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]
- Change in acceptance-based variables (e.g., mindfulness) [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 128 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SBT
Standard behavioral treatment based on the LEARN manual.
|
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).
|
|
Active Comparator: ABT
Acceptance-based group that is based on the behavioral interventions contained in LEARN manual
|
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).
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Drexel University |
| ClinicalTrials.gov Identifier: | NCT00746265 History of Changes |
| Other Study ID Numbers: | 1R21DK080430, 1R21DK080430 |
| Study First Received: | September 2, 2008 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Drexel University:
|
behavioral interventions for weight loss |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 19, 2013