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Motivational Interviewing for Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01246349
First received: November 11, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

The investigators will aim to determine the effect of motivational interviewing on self efficacy, health behaviors, and health outcomes in overweight adolescents.


Condition Intervention
Childhood Obesity
 Behavioral: Motivational Interviewing
Behavioral: Individual Standard Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Motivational Interviewing as an Intervention to Increase Adolescent Self Efficacy and Promote Weight Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Change in dietary self-efficacy from baseline [ Time Frame: Baseline to 6 months (measured monthly) and to 12 months ] [ Designated as safety issue: No ]
    Self efficacy is defined as an individual's belief and confidence in his or her own ability to make a behavior change.


Secondary Outcome Measures:
  • Physiological outcomes [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ] [ Designated as safety issue: No ]

    The study will use a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight will be measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age will be determined with the use of an age appropriate growth curve chart.

    The Weight Loss Behavior Scale (WLBS; Smith, Williamson, Womble, Johnson, & Burke, 2000) is a 35-item questionnaire designed to be a brief measure of changes in eating and exercise habits over the course of weight loss treatment.


  • Psychological well-being [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ] [ Designated as safety issue: No ]
    Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)


Estimated Enrollment: 32
Study Start Date: November 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing Group
Motivational Interviewing (MI) treatment group, a clinical psychology doctoral student trained in Motivational Interviewing will administer approximately six individual motivational interviewing treatment sessions approximately 30 minutes in length.
 Behavioral: Motivational Interviewing
Motivational interviewing (MI) can thus be defined as 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.
Active Comparator: Control Group
The control group will receive standard supportive therapy.
 Behavioral: Individual Standard Therapy
Six sessions of individual supportive therapy (administrator will use a script as a guideline for their intervention) in place of Motivational Interviewing (MI); sessions will be matched for session frequency and duration. This student will not be trained in motivational interviewing. They will be instructed to strictly focus on weekly exercise and food goals for the participant and will follow a semi-structured interview to control type and quality of therapy provided. These sessions will also be audio taped and reviewed by an MI expert to verify that MI techniques have not been used.

Detailed Description:

One empirically supported intervention with a large evidentiary base for improving adult outcomes in behavioral health-related disorders is Motivational Interviewing (MI). MI is strongly rooted in the client-centered therapy of Rogers (1951). Its relational stance emphasizes the importance of understanding the client's internal frame of reference and displaying unconditional positive regard for the client. Motivational interviewing can thus be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.

Adolescent participants exposed to motivational interviewing in conjunction with usual care (diet and exercise program) are expected to endorse greater self-efficacy, report increased engagement in healthy behaviors, demonstrate a decrease in body weight and report improved psychological outcomes. While Motivational Interviewing has been shown to increase adults' motivation to make healthy behavior changes, few adolescent studies have demonstrated this effect.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese youth (with Body Mass Index (BMI) >95th %ile for age and gender (as classified by the Center for Disease Control))
  • age 10-18 years, attending a local obesity clinic ("Healthy Weights" clinic) will be eligible to participate.

Time of entry into the weight-loss program will also be controlled for; however, both new and current participants will have the option to participate in the study.

Exclusion Criteria:

  • taking medication whose side effects may influence weight gain or weight loss
  • do not speak English
  • demonstrate a developmental delay
  • report being pregnant and/or report having an eating disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246349

Contacts
Contact: Munaza Jamil 416-813-7654 ext 3493 munaza.jamil@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Principal Investigator: Jill Hamilton, MD            
Sub-Investigator: Barbara Morrongiello            
Sub-Investigator: Elizabeth Dettmer            
Sub-Investigator: Beverly Walpole            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jill Hamilton, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Dr. Jill Hamilton/Staff Endocrinologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01246349     History of Changes
Other Study ID Numbers: 1000017625
Study First Received: November 11, 2010
Last Updated: November 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Motivational Interviewing
Adolescent Self-Efficacy
Health Behaviours

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013