An interventional study of AARC in Obesity, Childhood, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.
AA parents face unique racialized stressors which negatively impact their health and the health of their children. This heavy burden of chronic stress contributes to a high prevalence of anxiety and depression in AA parents. Parent stress negatively impacts child development and family health behaviors including diet and physical activity. A culturally-tailored intervention that addresses both AA parent stress and early childhood health and development has the potential to be more effective in promoting healthy family behaviors and AA parent mental health than traditional early childhood preventive care. Guided by AA parents and community members, the investigators propose to systematically co-develop a novel intervention using two frameworks: Centering and Superwoman Schema. The novel intervention will include group parent support, training in stress management and links to relevant community resources. The investigators will then determine the feasibility, acceptability, and limited efficacy of the adapted intervention in a pilot study.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 44 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
This intervention will adapt an already-existing evidence-based Centering Parenting program. Investigators will not provide clinical care to participants. Investigators will also address topics that are specific to African American families. Investigators will conduct 7 90 min sessions via zoom and in person.
Behavioral: AARC
This intervention will adapt an already-existing evidence-based Centering Parenting program addressing topics that are specific to African American families. There will be 7 90 min sessions via zoom. Group education topics include (parenting goals, infant feeding and sleep, self-care). Participants will complete surveys and interviews at various times to evaluate the program. The survey topics will include: parent stress, parent confidence and thoughts about the intervention. Surveys will be completed independently by participants online via redcap at a time that is convenient to them; if requested, the coordinator may complete the survey with the participant directly by phone /zoom. Interviews will be completed with a coordinator via zoom/phone.
Acceptability as measured by the Acceptability of Intervention Measure
Acceptability of Intervention Measure (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome.
Time frame: 7 months
Feasibility as measured by the Acceptability of Intervention Measure
Acceptability of Intervention Measure - Feasibility (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome
Time frame: 7 months
Semi-structured Interview
Semi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.
Time frame: 7 months
Parenting Confidence
Measured via Karitane Parenting Confidence Scale. Each item on the Karitane Parenting Confidence Scale is scored 0, 1, 2, or 3. There are no reverse-scored items and items have a common scoring order. That is, for each item the first response is scored 0, the second 1, and so on. Items marked not applicable are scored 2. Scores are then summed to give a total score (range = 0-45). The higher the range the better the outcome.
Time frame: 3 months and 6 months
Parent stress
Measured via perceived stress scale. Perceived Stress Scale score by following these directions: First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like• this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Now add up the scores for each item to get a total. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Time frame: At baseline and 5 months
Family Empowerment
Measured via the Family Empowerment Scale This measures scores for the subscales are simple means. Calculate the mean for each subscale by adding the scores for the subscale items that have NOT been answered "Not Applicable," and dividing by the number of questions that were answered "Never…Very Often" (1 through 5). If there are missing items (up to 3) in responses 1-5, add the scores for the subscale items, and divide by the number of answered questions. Add responses to all of the subscales for an overall score but be aware that each of the subscales addresses quite a different topic (Family, Service System, Community). Many published articles have employed the method of adding all items for an overall score. Examining each subscale score in relation to other variables of interest is another approach that may yield more specific information.
Time frame: 3 months and 6 months
GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE
Measured via average scores for each SWS subscale. RESPONSE VALUE This is NOT TRUE for me 0 This is TRUE for me RARELY 1 This is TRUE for me SOMETIMES 2 This is TRUE for me ALL THE TIME 3 If SWS subscale items are summed to create one SWS total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS Subscales: Strength (6 items): 0-6 Low 7-12 Moderate 13-18 High Suppress (7 items): 0-7 Low 8-14 Moderate 15-21 High Resistance (7 items): 0-7 Low 8-14 Moderate 15-21 High Motivation (6 items): 0-6 Low 7-12 Moderate 13-18 High Help (9 items): 0-9 Low 10-18 Moderate 19-27 High SWS appraisal items should be averaged. RESPONSE VALUE This bothers me NOT AT ALL 0 This bothers me SOMEWHAT 1 This bothers me VERY MUCH 2
Time frame: At baseline and 5 months
Session Evaluation
Session Evaluation(modified) uses the following scale: Strongly disagree / Disagree / Agree / Strongly agree. The more participants agree or completely agree, the better the outcome
Time frame: 1-7months
Plan to share: No — If we plan to share with other researchers in the future, we will submit an amendment to the IRB.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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