AARC Program for Childhood Obesity

(AARC Trial)

Overseen By Michelle J White, MD/MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Non-African American, Not pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the AARC Program can support the health of African American families, with a focus on physical and emotional well-being. The program adapts an existing parenting program to better meet the needs of African American families with newborns. Participants will engage in seven 90-minute sessions, both online and in person, covering topics relevant to their community. This trial suits African American individuals in North Carolina who expect a child in late 2024 and are comfortable participating in group discussions.

As an unphased trial, this study offers a unique opportunity to contribute to research that directly benefits the community.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for African American families?

Research shows that specific safety information for the AARC Program for Childhood Obesity is not yet available. However, similar programs addressing childhood obesity have yielded positive results. For instance, one study found that a program involving both children and their parents improved the fitness and health of obese children. Another program successfully slowed weight gain in young children who were already overweight.

While direct safety reports for the AARC intervention are lacking, similar programs have not reported major safety issues. The trial's "Not Applicable" phase indicates it is in the early stages, focusing on program delivery rather than risks or side effects. This suggests the program is likely non-invasive and generally well-tolerated, as trials at this stage typically prioritize safety and feasibility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for childhood obesity, which often involve medication, dietary changes, or physical activity plans, the AARC Intervention focuses on a culturally tailored approach. This program adapts the evidence-based Centering Parenting model and specifically addresses topics pertinent to African American families. Researchers are excited about this because it combines group support with culturally relevant education over seven sessions, aiming to foster long-term lifestyle changes in a community setting rather than just clinical care.

What evidence suggests that the AARC intervention is effective for childhood obesity?

Research shows that programs involving the whole family can help manage childhood obesity. In one study, children in a 10-month intensive program reduced their overweight status from 75% to 25%. Another study found that children in a family-based program lost an average of 2.3 kg over 12 weeks, while their parents lost an average of 6.4 kg. These results suggest that involving families in weight management can lead to significant weight loss for both children and their parents. The AARC intervention, which participants in this trial will receive, builds on these successful strategies by focusing on African American families. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle White, MD/MPH

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for African American/Black mothers and their infants, who are home within 96 hours of birth. Participants should be expecting a child due Aug/Sept 2024, comfortable in group discussions via Zoom with video, live in Durham, and receive care at Duke Children's Primary Care. Non-English speakers cannot participate.

Inclusion Criteria

Infant and mom home within 96 hours of birth

Identify as African American/Black

Expecting a child due Aug/Sept 2024

Exclusion Criteria

Non English Speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a culturally-tailored intervention including group parent support, stress management training, and links to community resources. Conducted over 7 sessions via Zoom and in-person.

7 months

7 sessions (mixed in-person and virtual)

Follow-up

Participants are monitored for the acceptability, feasibility, and limited efficacy of the intervention.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• AARC

Trial Overview

The study tests the AARC intervention designed to improve physical and socioemotional health among African American families. It assesses the feasibility of this approach for new mothers and their infants.

How Is the Trial Designed?

Group I: AARC Intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Duke Pediatrics, Children's Health and Discovery Initiative

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

A family-based behavioral weight control intervention for 192 children aged 8 to 12 resulted in a significant 7.58% decrease in percent overweight at 6 months, compared to only 0.66% in the usual care group.

Children who attended at least 75% of the intervention sessions were able to maintain their weight loss benefits over 18 months, highlighting the importance of consistent participation in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based treatment of severe pediatric obesity: randomized, controlled trial. Kalarchian, MA., Levine, MD., Arslanian, SA., et al.[2022]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

A 4-week summer camp for 21 children aged 8-13 with moderate to severe obesity resulted in an average weight loss of about 5% of their initial body weight, primarily from body fat rather than lean mass.

The program included dietary restrictions, exercise, swimming, and group therapy, and was conducted without any reported complications, indicating it is a safe and practical approach for initiating weight loss in obese children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A summer camp for childhood obesity in Thailand. Jirapinyo, P., Limsathayourat, N., Wongarn, R., et al.[2022]

There is a significant lack of research on obesity medications specifically for children and adolescents, despite many new treatments being approved for adults, highlighting a gap in pediatric obesity pharmacotherapy.

The article emphasizes the need for well-designed clinical trials that consider unique factors in the pediatric population, such as eligibility criteria and trial duration, to ensure the safety and efficacy of obesity medications for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations. Kelly, AS., Fox, CK., Rudser, KD., et al.[2022]

A patient-centered decision tool was developed to help address childhood obesity by identifying common goals between parents and healthcare providers, based on qualitative interviews with 44 parents and focus groups with 81 participants.

The tool, which includes a modified growth chart and sections for discussing patient-centered goals, was found to be acceptable and potentially useful, highlighting the importance of engaging families in obesity interventions for Latino children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a patient-centered outcome for targeting early childhood obesity across multiple stakeholders. Foster, BA., Winkler, P., Weinstein, K., et al.[2022]

A comprehensive evaluation of obese children and adolescents should include assessments of weight, body fat, and potential underlying health issues, as well as risk factors for diseases like diabetes and hypertension.

Successful obesity treatment involves setting realistic goals, promoting a balanced low-fat/high-fiber diet, achieving a safe weight loss of 1-2 pounds per week, increasing physical activity, and providing strong parental support along with behavior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of childhood obesity in pediatric practice. Williams, CL., Campanaro, LA., Squillace, M., et al.[2019]

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

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AARC Program for Childhood Obesity (AARC Trial)

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