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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

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date March 17, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • treatment attendance [ Time Frame: 12 months ]
    Participants attendance at each treatment group session was recorded.
  • treatment adherence [ Time Frame: 12 months ]
    Participants' self-monitoring of food intake was collected to determine adherence to this component of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Weight Management Programs Delivered in Large Versus Small Groups
Official Title  ICMJE Comparison of Weight Management Programs Delivered in Large Versus Small Groups
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: lifestyle intervention for obesity
Study Arms  ICMJE
  • Experimental: small group treatment
    lifestyle intervention for obesity delivered to small groups of approximately 12 participants/group
    Intervention: Behavioral: lifestyle intervention for obesity
  • Active Comparator: large group treatment
    lifestyle intervention for obesity delivered to a large group of approximately 30 participants
    Intervention: Behavioral: lifestyle intervention for obesity
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2014)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088749
Other Study ID Numbers  ICMJE K23DK081607-pilot
K23DK081607 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gareth R. Dutton PhD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gareth Dutton, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP