African American Resilient Caregivers (AARC)
Primary Purpose
Obesity, Childhood
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AARC
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
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
Sites / Locations
- Duke University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AARC Intervention
Arm Description
Participants in the AARC Intervention Arm will receive a 10 week intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05711979
First Posted
January 19, 2023
Last Updated
October 23, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT05711979
Brief Title
African American Resilient Caregivers
Acronym
AARC
Official Title
African American Resilient Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
COI disclosures
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AARC Intervention
Arm Type
Experimental
Arm Description
Participants in the AARC Intervention Arm will receive a 10 week intervention.
Intervention Type
Behavioral
Intervention Name(s)
AARC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability as assessed by semi-structured interviews
Description
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.
Time Frame
10 weeks (post intervention)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle White, MD/MPH
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
African American Resilient Caregivers
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