NCT01246349

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 21, 2014

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

November 11, 2010

Results QC Date

January 17, 2014

Last Update Submit

November 13, 2017

Conditions

Keywords

Motivational InterviewingChild and Adolescent Self-EfficacyHealth Behaviours

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 6 month follow-up

  • 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.

    Baseline, 6 month follow-up

Secondary Outcomes (3)

  • Physiological Outcomes: BMI

    Baseline, 6 month follow-up

  • Physiological Outcomes: Waist Circumference

    Baseline, 6 month follow-up

  • Psychological Well-being

    Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment

Study Arms (2)

Motivational Interviewing Group

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing (Treatment Group)

Control Group

ACTIVE COMPARATOR

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

Behavioral: Social Skills Training (Control Group)

Interventions

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.

Motivational Interviewing Group

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).

Control Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Motivational InterviewingControl Groups

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Beverly Walpole
Organization
The Hospital for Sick Children

Study Officials

  • Jill Hamilton, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Endocrinologist

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 23, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

November 17, 2017

Results First Posted

April 21, 2014

Record last verified: 2017-11

Locations