Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial

Not Applicable

Completed

• Conditions: Dyslipidemias
• Interventions: Other: Motivational Interviewing/Counselling

• Registration Number: NCT02730559
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The primary focus of this proposal is to address growing concern of overweight/ obese adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical trial to compare the effectiveness of Motivational interviewing (MI) interventions with the parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have more success due to the possible synergetic effect compared to adolescents alone. The study's primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes include overall improvement in their lifestyle and their responses to the MI intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-06
• Study First Submitted: 2016-03-31
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-05
• Study First Posted: 2016-04-06
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Age at randomization: 10-17 years old
• 12 hour fasting lipid profile with triglycerides ≥39 mg/dL (1.0 mmol/L) or HDL-C ≤46 mg/dL (1.2 mmol/L), and with non-HDL-C ≥123 mg/dL (3.2 mmol/L)
• Waist to height ratio ≥0.5.

Exclusion Criteria

• On lipid lowering medication
• non-English speaking
• Developmentally delayed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Motivational Interviewing/Counselling	Group A (Parent-adolescent dyads)
Control Group - Active Comparator	Motivational Interviewing/Counselling	Group B (Adolescents only)

Primary Outcome Measures

Name	Time	Method
Changes in total cholesterol to HDL-C ratio	Initial clinic visit (baseline); Repeated 6 months after baseline;