Effect of Managing Problematic Eating Behaviours With Dietary Management on Chronic Disease Self-management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier:
NCT01804881
First received: March 2, 2013
Last updated: June 4, 2014
Last verified: June 2014
Results First Received: February 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Type 2 Diabetes
Intervention: Behavioral: Lifestyle counseling

  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
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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
Lifestyle Counseling

Craving change group intervention for dietary counseling, 6 group sessions

Lifestyle counseling: Six week program to address problematic eating

Wait List Control wait list, offered program based on craving change(tm) material at end of study

Participant Flow:   Overall Study
    Lifestyle Counseling     Wait List Control  
STARTED     16     14  
COMPLETED     11     10  
NOT COMPLETED     5     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lifestyle Counseling

Craving change group intervention for dietary counseling, 6 group sessions

Lifestyle counseling: Six week program to address problematic eating

Wait List Control wait list, offered program based on craving change(tm) material at end of study
Total Total of all reporting groups

Baseline Measures
    Lifestyle Counseling     Wait List Control     Total  
Number of Participants  
[units: participants]
  16     14     30  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 4.9     59.9  ± 7.5     61.7  ± 6.2  
Gender  
[units: participants]
     
Female     14     7     21  
Male     2     7     9  
Region of Enrollment  
[units: participants]
     
Canada     16     14     30  
Body Mass Index (kg/m^2)  
[units: kg/m^2]
Mean ± Standard Deviation
  31.2  ± 5.1     32.8  ± 5.1     32  ± 5.1  



  Outcome Measures
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1.  Primary:   The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.   [ Time Frame: 6 weeks ]

2.  Secondary:   Change in Blood Pressure   [ Time Frame: 6 weeks ]

3.  Secondary:   Change in Weight   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 is limitation and was affected by small number recruited due to some participants declining participation due to being unable to come in for the day/time group program was offered and some participants dropped out during the study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: North York Family Health Team
phone: 4164943003 ext 130
e-mail: dsouthgate@nyfht.com


Publications:

Responsible Party: University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier: NCT01804881     History of Changes
Other Study ID Numbers: 13-0225
Study First Received: March 2, 2013
Results First Received: February 7, 2014
Last Updated: June 4, 2014
Health Authority: Canada: Ethics Review Committee