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

Dyslipidemias Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730559
• Other study ID #: 1000035605
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: April 5, 2016
• Start date: November 2012

Study information

• Verified date: April 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Other:
• Motivational Interviewing/Counselling
Motivational Interviewing/Counselling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total cholesterol to HDL-C ratio		Initial clinic visit (baseline); Repeated 6 months after baseline;	No