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

NCT ID: NCT02730559

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Group A (Parent-adolescent dyads)

Group Type EXPERIMENTAL

Motivational Interviewing/Counselling

Intervention Type OTHER

Motivational Interviewing/Counselling

Control Group - Active Comparator

Group B (Adolescents only)

Group Type ACTIVE_COMPARATOR

Motivational Interviewing/Counselling

Intervention Type OTHER

Motivational Interviewing/Counselling

Interventions

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Motivational Interviewing/Counselling

Motivational Interviewing/Counselling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Brian McCrindle

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1000035605

Identifier Type: -

Identifier Source: org_study_id

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