NCT02730559

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

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

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

March 31, 2016

Last Update Submit

April 5, 2016

Conditions

Dyslipidemias

Keywords

Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Changes in total cholesterol to HDL-C ratio

    Initial clinic visit (baseline); Repeated 6 months after baseline;

Study Arms (2)

Intervention Group

EXPERIMENTAL

Group A (Parent-adolescent dyads)

Other: Motivational Interviewing/Counselling

Control Group - Active Comparator

ACTIVE COMPARATOR

Group B (Adolescents only)

Other: Motivational Interviewing/Counselling

Interventions

Motivational Interviewing/CounsellingOTHER

Motivational Interviewing/Counselling

Control Group - Active ComparatorIntervention Group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age at randomization: 10-17 years old
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Motivational InterviewingCounseling

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesCommunity Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-04