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NCT03139214 Clinical Trial

Parenting Intervention and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:
Parenting Intervention and Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03139214
Other study ID # STUDY00000856
Secondary ID
Status Completed
Phase N/A
First received April 28, 2017
Last updated May 2, 2017
Start date August 27, 2001
Est. completion date December 30, 2015

Study information
Verified date May 2017
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 391
Est. completion date December 30, 2015
Est. primary completion date December 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria: 5th graders -

Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Parenting Intervention

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University University of Georgia

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Metabolic syndrome components Number of components of metabolic syndrome that were clinically elevated 14 years post-intervention
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