African American Resilient Caregivers

NCT ID: NCT05711979

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2023-03-10

Brief Summary

The purpose of this pilot study is to test the feasibility of a virtual intervention to prevent child obesity and cardiovascular disease in African American families.

Detailed Description

African American children experience a high prevalence of child obesity, increasing their subsequent risk of cardiovascular disease and diabetes. There is a lack of effective obesity prevention interventions for this population. Investigators also know that African American parents and caregivers experience high levels of stress and the manifestations of stress for African American women in particular may be unique and specific. Parent stress can lead to unhealthy family behaviors including less physical activity and a less healthy diet for parents and children. Given this background the investigators are creating a new intervention that combines an adapted evidence-based obesity prevention program (Competency Based Approach to Community Health - COACH) with mindfulness-based stress reduction tailored to African American women. As an initial step the investigators will pilot the intervention in a small number of African American women to determine whether the program is feasible.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

AARC Intervention

Participants in the AARC Intervention Arm will receive a 10 week intervention.

Group Type: EXPERIMENTAL

AARC

Intervention Type: BEHAVIORAL

There will be 10 90min weekly sessions. The first half of each session will consist of health education discussing diet, physical activity and screen time. Participants will set goals for themselves and their families. The investigators will check-in on goals and barriers to achieving goals in each session following the initial session. The second half of the sessions will focus on mindfulness based stress reduction including brief meditation, discussion of mindful eating and mindful parenting. This intervention will adapt an already-existing evidence-based obesity prevention program which has been administered to over 100 families (COACH), and it will add mindfulness-based stress reduction, tailored to African American women.

Interventions

AARC

There will be 10 90min weekly sessions. The first half of each session will consist of health education discussing diet, physical activity and screen time. Participants will set goals for themselves and their families. The investigators will check-in on goals and barriers to achieving goals in each session following the initial session. The second half of the sessions will focus on mindfulness based stress reduction including brief meditation, discussion of mindful eating and mindful parenting. This intervention will adapt an already-existing evidence-based obesity prevention program which has been administered to over 100 families (COACH), and it will add mindfulness-based stress reduction, tailored to African American women.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Identify as African American and female
• Have a child between the ages of 2-5 who lives with them at least 4 days per week that they care for as a parent or guardian.
• Feel comfortable discussing personal experiences and goals related to diet, PA, stress, parenting, etc. in front of a group of peers
• Access to zoom, preferably with video

Exclusion Criteria

• Non English Speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle White, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00111805

Identifier Type: -

Identifier Source: org_study_id