iAmHealthy for Childhood Obesity

Not yet recruiting at 3 trial locations

Overseen By Megan Olalde, MS, RD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Physical limitation, Cancer, Developmental delay, others

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

Compensation: Varies

Number of Visits: 66

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find effective ways to support families with children who are overweight or obese, focusing on those living in rural areas. It tests two approaches: an interactive program called iAmHealthy, which involves family-based group sessions, and a monthly newsletter providing health tips. Participating clinics will also receive support to enhance their health services. Children aged 6-11 with a BMI in the 85th percentile or higher and living in rural areas are suitable candidates. As an unphased trial, this study offers families the chance to contribute to innovative health solutions tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the iAmHealthy program is a family-based plan designed to assist children who are overweight or obese, particularly those in rural areas. Although specific safety data for iAmHealthy is not available, the program focuses on behavior, nutrition, and physical activity, suggesting it is likely safe and well-received. It emphasizes lifestyle changes rather than medication or medical procedures.

The study phase is labeled "Not Applicable," indicating that the trial aims to gather information on the program's effectiveness rather than test a new drug or treatment with unknown risks. Programs like iAmHealthy, which emphasize lifestyle changes, are generally considered safe because they do not involve drugs or medical procedures that might have side effects. Prospective participants should inquire about any possible risks or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iAmHealthy program for childhood obesity because it offers a unique, family-based approach tailored specifically for rural settings. Unlike typical treatments that might focus solely on diet or exercise, iAmHealthy involves both group and individual sessions over six months, providing a comprehensive behavioral intervention. Additionally, the Healthy Clinics intervention is designed to optimize clinic processes, ensuring healthcare providers have the tools and feedback needed to support families effectively. These combined strategies aim to create a supportive environment that can lead to sustainable lifestyle changes for children who are overweight or obese.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare the iAmHealthy program with a newsletter intervention. Studies have shown that the iAmHealthy program can significantly improve weight management in children who are overweight or obese. Designed for families, the program focuses on changing behaviors. Research indicates it works especially well in rural areas. Participants in these studies developed healthier habits over the long term, suggesting that iAmHealthy could be a promising option for managing childhood obesity. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul M Darden, MD

Principal Investigator

The University Of Oklahoma Health Sciences Center

Ann Davis, PhD, MPH, ABPP

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 6-11 living in rural areas with obesity (BMI ≥85th percentile) who speak English or Spanish. Their clinics must use electronic medical records and have seen at least 300 eligible kids last year. Kids with major health issues, cognitive impairments, siblings in the trial, physical limitations, or enrolled in another weight-loss study can't join.

Inclusion Criteria

Child lives in a rural area

History of collaboration with site awardee in research or quality improvement projects

In the past year at least 300 eligible potential participants

Exclusion Criteria

I cannot create lists of clinic visits by date, age, and zip code.

Child has a known medical issue that could affect protocol compliance (e.g., cancer)

Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iAmHealthy intervention or Newsletter control over six months

6 months

26 contact hours of group and individual intervention

Healthy Clinic Intervention

Clinic level intervention to improve provider office processes using a bundled intervention of provider prompts, skills training, and intervention tools

3.5 years

Random audit of 40 medical records every 6 months

Follow-up

Participants are monitored for changes in BMI, physical activity, and dietary behavior

Year 4

What Are the Treatments Tested in This Trial?

Interventions

• iAmHealthy
• Newsletter

Trial Overview The iAmHealthy Clinical Practice Guideline (CPG) trial tests two strategies to tackle childhood obesity: a 'Healthy Clinic' intervention versus control period at the clinic level and 'iAmHealthy' program versus newsletters for individual patients. It's a randomized controlled trial affecting both clinics and their patients.

How Is the Trial Designed?

Group I: Participants: iAmHealthy Experimental Treatment 1 Intervention

The iAmHealthy intervention is a rurally tailored empirically supported family-based behavioral group program targeting the families of children who are overweight or obese and providing 26 contact hours of group and individual intervention over six months.

Group II: Clinics: Healthy Clinics Experimental Treatment 3 Interventions

Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Clinics are randomized to the order in which they undertake the individually randomized iAmHealthy vs. Newsletter intervention and the cluster randomized Healthy Clinic intervention

Group III: Participants: Newsletter Active Control 1 Intervention

Families will receive a monthly newsletter for six months.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The iAmHealthy intervention is a unique, family-based program designed specifically for rural children, addressing pediatric obesity through mobile health applications over an 8-month period, involving 144 children across 18 schools.

This study is the first randomized controlled trial to implement a rural-focused, mHealth intervention for pediatric obesity, measuring outcomes like Body Mass Index z-score (BMIz) and physical activity, with data collected at multiple time points to assess effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Davis, AM., Beaver, G., Dreyer Gillette, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922440/

Primary Outcomes of a Cluster Randomized Control Trial Results suggest iAmHealthy resulted in a change in BMIz trajectories and long-term health behavior for youth.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT03304249/Prot_SAP_000.pdf

iAmHealthy: A Home-based Rural Pediatric Obesity ... The purpose of this study our primary aim is to assess the effectiveness of rural pediatric obesity treatment delivered virtually to family ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171441830538X

iAmHealthy: Rationale, design and application of a family- ... Specifically, we hypothesize that the iAmHealthy intervention will result in significantly decreased child BMIz and parent BMI compared to the control ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ijpo.13094

Effectiveness of a paediatric weight management ... This paper evaluates the effectiveness of iAmHealthy, a family-based paediatric obesity intervention delivered to rural children, compared to a Newsletter ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6387830/

iAmHealthy: Rationale, design and application of a family ... The results of the iAmHealthy trial may significantly impact the way we treat obesity among rural children and families by providing a scalable ...

6. withpower.com withpower.com/trial/phase-obesity-2023-7a94d

iAmHealthy Program for Family Obesity Management Research has shown that specific safety data from past studies for the iAmHealthy Parents First program is not available. This program assists adults in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30630108/

iAmHealthy: Rationale, design and application of a ... - PubMed iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families.