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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01246349
Other study ID # 1000017625
Secondary ID
Status Completed
Phase N/A
First received November 11, 2010
Last updated November 13, 2017
Start date September 2010
Est. completion date November 2012

Study information

Verified date November 2017
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing (Treatment Group)
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.
Social Skills Training (Control 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).

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Baseline, 6 month follow-up
Secondary Physiological Outcomes: Waist Circumference Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained. Baseline, 6 month follow-up
Secondary Psychological Well-being Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE) Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment
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