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

Trial Summary

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 data supports the effectiveness of the AARC treatment for childhood obesity?

The research suggests that successful treatment of childhood obesity often involves a combination of dietary changes, increased physical activity, and behavior therapy, which are components that may be part of the AARC treatment. These approaches have been shown to help children achieve healthier weight and improve related health factors. ^{1 2 3 4 5}

What safety data exists for the AARC Program for Childhood Obesity treatment?

The research articles reviewed do not provide specific safety data for the AARC Program for Childhood Obesity treatment. ^{6 7 8 9 10}

How does the AARC treatment for childhood obesity differ from other treatments?

The AARC treatment for childhood obesity is unique because it involves a comprehensive aftercare program that transitions patients from inpatient rehabilitation to ambulatory care, ensuring ongoing support and management. This approach addresses the high relapse rate seen in other treatments by providing continuous case management and support for families, which is not commonly found in standard obesity treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.

Research Team

Michelle White, MD/MPH

Principal Investigator

Duke Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Developing a patient-centered outcome for targeting early childhood obesity across multiple stakeholders. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of a FITLINE to Support Families of Overweight and Obese Children in Pediatric Practices. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Management of childhood obesity in pediatric practice. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Framework of outcome measures recommended for use in the evaluation of childhood obesity treatment interventions: the CoOR framework. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Childhood Obesity Prevention and Treatment Research (COPTR): interventions addressing multiple influences in childhood and adolescent obesity. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Family-based treatment of severe pediatric obesity: randomized, controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Swedish Youth with Obesity cohort: Profile of an ongoing prospective study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[Aftercare Following Inpatient Rehabilitation of Patients with Obesity: Feasibility of the KgAS-Concept]. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Ambulant training programs for obese children. Criterions of comparison for the development of valid therapy recommendations]. [2019]

13. India pubmed.ncbi.nlm.nih.gov

Management of pediatric obesity: a lifestyle modification approach. [2021]

14. Thailand pubmed.ncbi.nlm.nih.gov

A summer camp for childhood obesity in Thailand. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Training in childhood obesity management in the United States: a survey of pediatric, internal medicine-pediatrics and family medicine residency program directors. [2022]