African American Resilient Caregivers

NCT05711979 | Terminated

• 1 other identifier: Pro00111805
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

AARC Intervention

EXPERIMENTAL

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

Behavioral: AARC

Interventions

AARC 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.

AARC Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non English Speaking

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological 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: January 19, 2023
• First Posted: February 3, 2023
• Study Start: February 7, 2023
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: June 5, 2024

Record last verified: 2023-01

Locations

US (1)