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CompletedNCT03139214Updated May 3, 2017

Parenting Intervention and Metabolic Syndrome

An interventional study of Parenting Intervention in Metabolic Syndrome, sponsored by Northwestern University. Completed. Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by Northwestern University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 15 years 8 months after the study started (first participant enrolled Aug 2001, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
391
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.

This study's enrollment of 391 is above the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: 5th graders -

Exclusion Criteria: None

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
391 participants (actual)

Study arms

  • 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.

Interventions

  • BehavioralParenting Intervention
06

What researchers measure

Primary outcomes

  1. Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)

    Metabolic syndrome diagnosis

    Time frame: 14 years post-intervention

  2. Metabolic syndrome components

    Number of components of metabolic syndrome that were clinically elevated

    Time frame: 14 years post-intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03139214
Lead sponsor
Northwestern University
Collaborators
University of Georgia
Responsible party
Sponsor
First posted
May 3, 2017
Start date
Aug 27, 2001
Primary completion
Dec 30, 2015
Completion
Dec 30, 2015
Last update
May 3, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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