Comparison of Weight Management Programs Delivered in Large Versus Small Groups

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

Tracking Information

• First Submitted Date: March 12, 2014
• First Posted Date: March 17, 2014
• Last Update Posted Date: March 17, 2014
• Study Start Date: May 2010
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Weight Management Programs Delivered in Large Versus Small Groups
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity
• Intervention: Behavioral: lifestyle intervention for obesity

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 13, 2014): 66
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02088749
• Other Study ID Numbers: K23DK081607-pilot; K23DK081607 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gareth R. Dutton PhD, University of Alabama at Birmingham
• Study Sponsor: University of Alabama at Birmingham
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gareth Dutton, PhD; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: March 2014