NCT03139214

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2001

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

14.4 years

First QC Date

April 28, 2017

Last Update Submit

May 2, 2017

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Parenting intervention, 7 weekly sessions, each session 2 hours in length.

Behavioral: Parenting Intervention

Control

NO INTERVENTION

3 mailings about child development and stress management.

Interventions

Parenting InterventionBEHAVIORAL
Intervention

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 3, 2017

Study Start

August 27, 2001

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share