African American Resilient Caregivers

Obesity, Childhood Clinical Trial

— AARC  

Official title:

African American Resilient Caregivers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05711979
• Other study ID #: Pro00111805
• Status: Terminated
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: March 10, 2023

Study information

• Verified date: January 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability as assessed by semi-structured interviews	In this pilot study, acceptability of the intervention to the study population will be assessed by semi-structured interviews. Interview questions will identify features of the intervention which were beneficial to participants as well as barriers to participation.	10 weeks (post intervention)