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Motivational Interviewing for Weight Loss

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational Interviewing (Treatment Group)
Social Skills Training (Control Group)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Motivational Interviewing, Child and Adolescent Self-Efficacy, Health Behaviours

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obese youth (with Body Mass Index (BMI) ≥ to 85th percentile for age and gender (as classified by the Center for Disease Control))
  • ages 10-18 years
  • attending a local obesity clinic ("Healthy Weights" clinic)

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

Exclusion Criteria:

  • taking medication whose side effects may influence weight gain or weight loss
  • did not speak English
  • demonstrated a developmental delay
  • reported being pregnant and/or reported having an eating disorder

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing Group

Control Group

Arm Description

For the Motivational Interviewing (MI) treatment group, a clinical psychology doctoral student trained in Motivational Interviewing administered six individual motivational interviewing treatment sessions, each 30 minutes in length.

The comparison group received six social skills training sessions instead of Motivational Interviewing (MI).

Outcomes

Primary Outcome Measures

Weight Efficacy Life-style Questionnaire
A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight. The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident). The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses. The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined.
Child Dietary Self-Efficacy Scale
A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods. The questionnaire is made up of 20 likert items with 3 response options, including "not sure", "a little sure", and "very sure". Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, "How sure are you that you could eat cereal instead of a donut?" Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy.

Secondary Outcome Measures

Physiological Outcomes: BMI
The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.
Physiological Outcomes: Waist Circumference
Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.
Psychological Well-being
Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)

Full Information

First Posted
November 11, 2010
Last Updated
November 13, 2017
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01246349
Brief Title
Motivational Interviewing for Weight Loss
Official Title
Motivational Interviewing as an Intervention to Increase Adolescent Self-Efficacy and Promote Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators studied the effect of motivational interviewing (MI) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years).
Detailed Description
One empirically supported intervention with a large evidence 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Motivational Interviewing, Child and Adolescent Self-Efficacy, Health Behaviours

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing Group
Arm Type
Experimental
Arm Description
For the Motivational Interviewing (MI) treatment group, a clinical psychology doctoral student trained in Motivational Interviewing administered six individual motivational interviewing treatment sessions, each 30 minutes in length.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The comparison group received six social skills training sessions instead of Motivational Interviewing (MI).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (Treatment Group)
Intervention Description
Motivational interviewing (MI) can 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.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training (Control Group)
Intervention Description
Within the social skills training framework, advice is given to clients and sessions are focused on assigning goals for clients to work towards without specific regard for their readiness to change. The intervention is aimed at finding appropriate ways to navigate typical social situations (e.g., how to negotiate with parents).
Primary Outcome Measure Information:
Title
Weight Efficacy Life-style Questionnaire
Description
A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight. The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident). The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses. The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined.
Time Frame
Baseline, 6 month follow-up
Title
Child Dietary Self-Efficacy Scale
Description
A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods. The questionnaire is made up of 20 likert items with 3 response options, including "not sure", "a little sure", and "very sure". Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, "How sure are you that you could eat cereal instead of a donut?" Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy.
Time Frame
Baseline, 6 month follow-up
Secondary Outcome Measure Information:
Title
Physiological Outcomes: BMI
Description
The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.
Time Frame
Baseline, 6 month follow-up
Title
Physiological Outcomes: Waist Circumference
Description
Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.
Time Frame
Baseline, 6 month follow-up
Title
Psychological Well-being
Description
Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)
Time Frame
Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obese youth (with Body Mass Index (BMI) ≥ to 85th percentile for age and gender (as classified by the Center for Disease Control)) ages 10-18 years attending a local obesity clinic ("Healthy Weights" clinic) Time of entry into the weight-loss program was controlled for; however, both new and current participants had the option to participate in the study. Exclusion Criteria: taking medication whose side effects may influence weight gain or weight loss did not speak English demonstrated a developmental delay reported being pregnant and/or reported having an eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Motivational Interviewing for Weight Loss

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