Motivational Interviewing for Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jill Hamilton, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01246349
First received: November 11, 2010
Last updated: March 15, 2014
Last verified: March 2014
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Childhood Obesity
Interventions: Behavioral: Motivational Interviewing (Treatment Group)
Behavioral: Social Skills Training (Control Group)

  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
Overweight and obese youth (BMI ≥ 85th %ile for age and gender) were eligible to participate and were recruited directly by the primary investigators from the Toronto East General Hospital's Healthy Lifestyles program, comprised of children and adolescents ages 10-18 years who are seeking diet and exercise treatment for their obesity.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals were excluded if they: 1) were taking medication whose side effects may influence weight gain or weight loss, 2) did not speak English, 3) had a known developmental delay, and 4) reported being pregnant and/or having an active eating disorder.

Reporting Groups
  Description
Control Group

The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.

The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).

Treatment/Experimental Group

The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.

A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.


Participant Flow:   Overall Study
    Control Group     Treatment/Experimental Group  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  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
Treatment Group (Motivational Interviewing)

The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client’s intrinsic motivation to change by exploring and resolving ambivalence.

MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.

Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student.

Control (Social Skills Training)

The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.

The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients’ readiness to change was made in this group.

Total Total of all reporting groups

Baseline Measures
    Treatment Group (Motivational Interviewing)     Control (Social Skills Training)     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     20     20     40  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.1  ± 1.8     13.7  ± 1.7     13.9  ± 1.7  
Gender  
[units: participants]
     
Female     14     9     23  
Male     6     11     17  
Region of Enrollment  
[units: participants]
     
Canada     20     20     40  



  Outcome Measures
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1.  Primary:   Weight Efficacy Life-style Questionnaire   [ Time Frame: Baseline, 6 month follow-up ]

2.  Primary:   Child Dietary Self-Efficacy Scale   [ Time Frame: Baseline, 6 month follow-up ]

3.  Secondary:   Physiological Outcomes: BMI   [ Time Frame: Baseline, 6 month follow-up ]

4.  Secondary:   Physiological Outcomes: Waist Circumference   [ Time Frame: Baseline, 6 month follow-up ]

5.  Secondary:   Psychological Well-being   [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
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  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: Beverly Walpole
Organization: The Hospital for Sick Children
phone: 416. 813 7654 ext 328363
e-mail: bwalpole@uoguelph.ca


No publications provided


Responsible Party: Jill Hamilton, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01246349     History of Changes
Other Study ID Numbers: 1000017625
Study First Received: November 11, 2010
Results First Received: January 17, 2014
Last Updated: March 15, 2014
Health Authority: Canada: Ethics Review Committee