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Portion Control Treatment for Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01451554
First received: October 11, 2011
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
Results First Received: October 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Interventions: Behavioral: portion control plate
Behavioral: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Portion Control Intervention Individuals will be given a portion control plate and dietary counseling
Usual Care Provided with self-help booklets on diet and exercise.

Participant Flow:   Overall Study
    Portion Control Intervention     Usual Care  
STARTED     33     32  
COMPLETED     19     23  
NOT COMPLETED     14     9  
Withdrawal by Subject                 14                 9  



  Baseline Characteristics
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Reporting Groups
  Description
Portion Control Intervention Individuals will be given a portion control plate and dietary counseling
Usual Care Provided with self-help booklets on diet and exercise.
Total Total of all reporting groups

Baseline Measures
    Portion Control Intervention     Usual Care     Total  
Number of Participants  
[units: participants]
 		  33     32     65  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     28     24     52  
>=65 years     5     8     13  
Age  
[units: years]
Mean ± Standard Deviation 		  55.4  ± 9.4     56.3  ± 10.7     55.9  ± 10.0  
Gender  
[units: participants]
 		     
Female     20     20     40  
Male     13     12     25  
Baseline Weight [1]
[units: Kg]
Mean ± Standard Deviation 		  97.6  ± 12.8     98.8  ± 12.5     98.2  ± 12.6  
[1] Weight in Kilograms at the study entry



  Outcome Measures
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1.  Primary:   Weight Change at 6 Months   [ Time Frame: 6 months ]
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2.  Secondary:   Weight Change at 3 Months   [ Time Frame: 3 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size and inability to blind staff/study subject to the intervenion  


Results Point of Contact:  
Name/Title: Jon O. Ebbert, MD
Organization: Mayo Clinic
phone: 507-255-3965
e-mail: ebbert.jon@mayo.edu


Publications of Results:


Responsible Party: Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01451554     History of Changes
Other Study ID Numbers: 02-003653
Study First Received: October 11, 2011
Results First Received: October 19, 2011
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board