Back to resultsMotivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interviewing/Counselling
Sponsored by
About this trial
This is an interventional prevention trial for Dyslipidemias focused on measuring Motivational Interviewing
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group - Active Comparator
Arm Description
Group A (Parent-adolescent dyads)
Group B (Adolescents only)
Outcomes
Primary Outcome Measures
Changes in total cholesterol to HDL-C ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT02730559
First Posted
March 31, 2016
Last Updated
April 5, 2016
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT02730559
Brief Title
Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Motivational Interviewing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Group A (Parent-adolescent dyads)
Arm Title
Control Group - Active Comparator
Arm Type
Active Comparator
Arm Description
Group B (Adolescents only)
Intervention Type
Other
Intervention Name(s)
Motivational Interviewing/Counselling
Intervention Description
Motivational Interviewing/Counselling
Primary Outcome Measure Information:
Title
Changes in total cholesterol to HDL-C ratio
Time Frame
Initial clinic visit (baseline); Repeated 6 months after baseline;
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
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