NCT06458790

Brief Summary

To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

January 30, 2026

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

June 6, 2024

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptability as measured by the Acceptability of Intervention Measure

    Acceptability of Intervention Measure (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome.

    7 months

  • Feasibility as measured by the Acceptability of Intervention Measure

    Acceptability of Intervention Measure - Feasibility (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome

    7 months

  • Semi-structured Interview

    Semi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.

    7 months

Secondary Outcomes (5)

  • Parenting Confidence

    3 months and 6 months

  • Parent stress

    At baseline and 5 months

  • Family Empowerment

    3 months and 6 months

  • GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE

    At baseline and 5 months

  • Session Evaluation

    1-7months

Study Arms (1)

AARC Intervention

EXPERIMENTAL

This intervention will adapt an already-existing evidence-based Centering Parenting program. Investigators will not provide clinical care to participants. Investigators will also address topics that are specific to African American families. Investigators will conduct 7 90 min sessions via zoom and in person.

Behavioral: AARC

Interventions

AARCBEHAVIORAL

This intervention will adapt an already-existing evidence-based Centering Parenting program addressing topics that are specific to African American families. There will be 7 90 min sessions via zoom. Group education topics include (parenting goals, infant feeding and sleep, self-care). Participants will complete surveys and interviews at various times to evaluate the program. The survey topics will include: parent stress, parent confidence and thoughts about the intervention. Surveys will be completed independently by participants online via redcap at a time that is convenient to them; if requested, the coordinator may complete the survey with the participant directly by phone /zoom. Interviews will be completed with a coordinator via zoom/phone.

AARC Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as African American/Black
  • Expecting a child due September, October or November 2024
  • Feel comfortable discussing personal experiences and asking questions in front of a group of peers
  • Access to zoom, preferably with video
  • Live in North Carolina
  • Infant and mom home within 96 hours of birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle White, MD/MPH

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 14, 2024

Study Start

September 20, 2024

Primary Completion

November 25, 2025

Study Completion

November 25, 2025

Last Updated

January 30, 2026

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

If we plan to share with other researchers in the future, we will submit an amendment to the IRB.

Locations