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Behavioral Treatment for Weight Loss (MYH)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight loss intervention
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring behavioral interventions for weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Drexel University, Department of Psychology, 245 N. 15th Street, MS 626

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SBT

ABT

Arm Description

Standard behavioral treatment based on the LEARN manual.

Acceptance-based group that is based on the behavioral interventions contained in LEARN manual

Outcomes

Primary Outcome Measures

BMI change

Secondary Outcome Measures

Change in acceptance-based variables (e.g., mindfulness)

Full Information

First Posted
September 2, 2008
Last Updated
August 5, 2013
Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00746265
Brief Title
Behavioral Treatment for Weight Loss
Acronym
MYH
Official Title
Acceptance-based Behavior Treatment: An Innovative Weight Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
behavioral interventions for weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBT
Arm Type
Active Comparator
Arm Description
Standard behavioral treatment based on the LEARN manual.
Arm Title
ABT
Arm Type
Active Comparator
Arm Description
Acceptance-based group that is based on the behavioral interventions contained in LEARN manual
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
BMI change
Time Frame
end of treatment and 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in acceptance-based variables (e.g., mindfulness)
Time Frame
end of treatment and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Drexel University, Department of Psychology, 245 N. 15th Street, MS 626
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30806492
Citation
Forman EM, Manasse SM, Butryn ML, Crosby RD, Dallal DH, Crochiere RJ. Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. Obesity (Silver Spring). 2019 Apr;27(4):565-571. doi: 10.1002/oby.22412. Epub 2019 Feb 26.
Results Reference
derived
PubMed Identifier
23666772
Citation
Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13. Erratum In: Obesity (Silver Spring). 2014 Mar;22(3):971.
Results Reference
derived

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Behavioral Treatment for Weight Loss

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