Parenting Intervention and Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parenting Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria: 5th graders -
Exclusion Criteria: None
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Parenting intervention, 7 weekly sessions, each session 2 hours in length.
3 mailings about child development and stress management.
Outcomes
Primary Outcome Measures
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)
Metabolic syndrome diagnosis
Metabolic syndrome components
Number of components of metabolic syndrome that were clinically elevated
Secondary Outcome Measures
Full Information
NCT ID
NCT03139214
First Posted
April 28, 2017
Last Updated
May 2, 2017
Sponsor
Northwestern University
Collaborators
University of Georgia
1. Study Identification
Unique Protocol Identification Number
NCT03139214
Brief Title
Parenting Intervention and Metabolic Syndrome
Official Title
Parenting Intervention and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 27, 2001 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.
Detailed Description
In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
391 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Parenting intervention, 7 weekly sessions, each session 2 hours in length.
Arm Title
Control
Arm Type
No Intervention
Arm Description
3 mailings about child development and stress management.
Intervention Type
Behavioral
Intervention Name(s)
Parenting Intervention
Primary Outcome Measure Information:
Title
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)
Description
Metabolic syndrome diagnosis
Time Frame
14 years post-intervention
Title
Metabolic syndrome components
Description
Number of components of metabolic syndrome that were clinically elevated
Time Frame
14 years post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 5th graders -
Exclusion Criteria: None
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Parenting Intervention and Metabolic Syndrome
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