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Comparison of Weight Management Programs Delivered in Large Versus Small Groups

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ClinicalTrials.gov Identifier: NCT02088749
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Gareth R. Dutton PhD, University of Alabama at Birmingham

Study Description
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Brief Summary:
The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: lifestyle intervention for obesity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Weight Management Programs Delivered in Large Versus Small Groups
Study Start Date : May 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: small group treatment
lifestyle intervention for obesity delivered to small groups of approximately 12 participants/group
 Behavioral: lifestyle intervention for obesity
Active Comparator: large group treatment
lifestyle intervention for obesity delivered to a large group of approximately 30 participants
 Behavioral: lifestyle intervention for obesity


Outcome Measures
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Primary Outcome Measures :
  1. change in body weight from baseline to months 6 and 12 [ Time Frame: baseline, month 6, month 12 ]
    Weight will be measured to the nearest 0.1 kg using calibrated digital scales at baseline, month 6, and month 12.


Secondary Outcome Measures :
  1. treatment attendance [ Time Frame: 12 months ]
    Participants attendance at each treatment group session was recorded.

  2. treatment adherence [ Time Frame: 12 months ]
    Participants' self-monitoring of food intake was collected to determine adherence to this component of treatment.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 21 years-old
  • body mass index (BMI) between 30-45

Exclusion Criteria:

  • have lost >4.5 kg in past six months
  • have medical condition(s) likely to affect ability to participate in physical activity
  • planning to relocate from the area in next 12 months
  • unable or unwilling to attend weekly group sessions
  • unwilling to accept random assignment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088749


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32309
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Gareth Dutton, PhD University of Alabama at Birmingham
More Information
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Responsible Party: Gareth R. Dutton PhD, Associate Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02088749    
Other Study ID Numbers: K23DK081607-pilot
K23DK081607 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by Gareth R. Dutton PhD, University of Alabama at Birmingham:
obesity
weight loss
treatment
lifestyle
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight