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Parenting Intervention and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parenting Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 28, 2017
    Last Updated
    May 2, 2017
    Sponsor
    Northwestern University
    Collaborators
    University of Georgia
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    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

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    Parenting Intervention and Metabolic Syndrome

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