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Obesity, ChildhoodAARCNCT06458790

Black Resilient Caregivers

A study testing AARC in people with Obesity, Childhood, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
AARC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
20 Sep 2024to 25 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Health System

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: African American Resilient Caregivers

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

Read the detailed description

AA parents face unique racialized stressors which negatively impact their health and the health of their children. This heavy burden of chronic stress contributes to a high prevalence of anxiety and depression in AA parents. Parent stress negatively impacts child development and family health behaviors including diet and physical activity. A culturally-tailored intervention that addresses both AA parent stress and early childhood health and development has the potential to be more effective in promoting healthy family behaviors and AA parent mental health than traditional early childhood preventive care. Guided by AA parents and community members, the investigators propose to systematically co-develop a novel intervention using two frameworks: Centering and Superwoman Schema. The novel intervention will include group parent support, training in stress management and links to relevant community resources. The investigators will then determine the feasibility, acceptability, and limited efficacy of the adapted intervention in a pilot study.

Being tested
AARC
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AARCBehavioural

    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.

Study groups in NCT06458790
Study groupRoleWhat they receive
AARC InterventionExperimentalThis 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.
Receives: Behavioral: AARC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 months

  2. 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

    Measured: 7 months

  3. Semi-structured Interview

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

    Measured: 7 months

Secondary outcomes (5)

  1. Parenting Confidence

    Measured via Karitane Parenting Confidence Scale. Each item on the Karitane Parenting Confidence Scale is scored 0, 1, 2, or 3. There are no reverse-scored items and items have a common scoring order. That is, for each item the first response is scored 0, the second 1, and so on. Items marked not applicable are scored 2. Scores are then summed to give a total score (range = 0-45). The higher the range the better the outcome.

    Measured: 3 months and 6 months

  2. Parent stress

    Measured via perceived stress scale.

    Perceived Stress Scale score by following these directions:

    First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like• this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Now add up the scores for each item to get a total. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress.

    Measured: At baseline and 5 months

  3. Family Empowerment

    Measured via the Family Empowerment Scale

    This measures scores for the subscales are simple means. Calculate the mean for each subscale by adding the scores for the subscale items that have NOT been answered "Not Applicable," and dividing by the number of questions that were answered "Never…Very Often" (1 through 5). If there are missing items (up to 3) in responses 1-5, add the scores for the subscale items, and divide by the number of answered questions.

    Add responses to all of the subscales for an overall score but be aware that each of the subscales addresses quite a different topic (Family, Service System, Community). Many published articles have employed the method of adding all items for an overall score.

    Examining each subscale score in relation to other variables of interest is another approach that may yield more specific information.

    Measured: 3 months and 6 months

  4. GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE

    Measured via average scores for each SWS subscale.

    RESPONSE VALUE This is NOT TRUE for me 0 This is TRUE for me RARELY 1 This is TRUE for me SOMETIMES 2 This is TRUE for me ALL THE TIME 3

    If SWS subscale items are summed to create one SWS total, these categories can be used:

    0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS

    Subscales:

    Strength (6 items):

    0-6 Low 7-12 Moderate 13-18 High

    Suppress (7 items):

    0-7 Low 8-14 Moderate 15-21 High

    Resistance (7 items):

    0-7 Low 8-14 Moderate 15-21 High

    Motivation (6 items):

    0-6 Low 7-12 Moderate 13-18 High

    Help (9 items):

    0-9 Low 10-18 Moderate 19-27 High

    SWS appraisal items should be averaged.

    RESPONSE VALUE This bothers me NOT AT ALL 0 This bothers me SOMEWHAT 1 This bothers me VERY MUCH 2

    Measured: At baseline and 5 months

  5. Session Evaluation

    Session Evaluation(modified) uses the following scale: Strongly disagree / Disagree / Agree / Strongly agree.

    The more participants agree or completely agree, the better the outcome

    Measured: 1-7months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start20 Sep 2024
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458790
Sponsor's protocol ID
Pro00111805_1
Acronym
AARC
Status last verified
Sep 2024
First submitted
6 Jun 2024
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: If we plan to share with other researchers in the future, we will submit an amendment to the IRB.

Questions about this trial

What is this clinical trial studying?

A study testing AARC in people with Obesity, Childhood, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability as measured by the Acceptability of Intervention Measure (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06458790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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