Parenting Intervention and Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Parenting Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: 5th graders -

Exclusion Criteria: None

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Parenting intervention, 7 weekly sessions, each session 2 hours in length.	Behavioral: Parenting Intervention
No Intervention: Control; 3 mailings about child development and stress management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)	Metabolic syndrome diagnosis	14 years post-intervention
Metabolic syndrome components	Number of components of metabolic syndrome that were clinically elevated	14 years post-intervention

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Georgia

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2001
• Primary Completion (Actual): December 30, 2015
• Study Completion (Actual): December 30, 2015

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: STUDY00000856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No