Obesity, ChildhoodAARCNCT05711979
African American Resilient Caregivers
A study testing AARC in people with Obesity, Childhood, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- AARC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 10 Mar 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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.
Read the 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
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| AARC Intervention | Experimental | Participants in the AARC Intervention Arm will receive a 10 week intervention. Receives: Behavioral: AARC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start7 Feb 2023
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Why it stopped: COI disclosures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Michelle White, MD/MPH, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711979
- Sponsor's protocol ID
- Pro00111805
- Acronym
- AARC
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Resilient Caregivers
- ClinicalTrials.gov ID
- NCT05711979
- Acronym / sponsor ID
- AARC / Pro00111805
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COI disclosures
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AARC Intervention | Experimental | Behavioral: AARCParticipants in the AARC Intervention Arm will receive a 10 week intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Non English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AARCThere 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. | Behavioural | AARC Intervention |
Primary outcome
Acceptability as assessed by semi-structured interviews
Time frame: 10 weeks (post intervention)
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.
Results and safety
The study was stopped early (reason given: COI disclosures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle White, MD/MPH principal investigator
Duke Health
1 site in 1 country: see every site and its status.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Jun 2024. 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 was stopped early (reason given: COI disclosures). Results are not available in the source record.
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 assessed by semi-structured interviews (time frame: 10 weeks (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.