1024 Participants Needed

iAmHealthy for Childhood Obesity

Recruiting at 3 trial locations
AM
MO
Overseen ByMegan Olalde, MS, RD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter).

Will I have to stop taking my current medications?

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

How is the iAmHealthy treatment for childhood obesity different from other treatments?

iAmHealthy is unique because it is a family-based intervention specifically designed for rural children, using mobile health applications (mHealth) to deliver a comprehensive program of behavioral, nutrition, and physical activity support over 8 months. This approach is tailored to address the unique barriers faced by rural populations, such as limited access to healthcare and fewer opportunities for physical activity.12345

Who Is on the Research Team?

PM

Paul M Darden, MD

Principal Investigator

The University Of Oklahoma Health Sciences Center

AD

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
See 3 more

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
See 3 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Participants: iAmHealthyExperimental Treatment1 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 ClinicsExperimental Treatment3 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: NewsletterActive Control1 Intervention
Families will receive a monthly newsletter for six months.

Find a Clinic Near You

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.
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

Evaluating obesity and cardiovascular risk factors in children and adolescents. [2008]
iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. [2020]
3. Management and prevention of obesity and its complications in children and adolescents. [2020]
Pediatric obesity screening and prevention strategies. [2016]
Establishing validity and reliability of an instrument using the theory of planned behavior to predict middle school student obesity-related actions. [2011]
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