iAmHealthy Clinical Practice Guideline (CPG)

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06888011
Status
Recruiting
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Conditions

  • Clinical Practice Guideline
  • Pediatric Obesity
  • Rural Health

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Participants: iAmHealthy — BEHAVIORAL
    Families will take part in an educational group program with parents and their children. These one-hour meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur weekly for three months and monthly for three months. Each family will also have the opportunity to receive individual health coaching sessions every other week that will last approximately 30 minutes to address concerns and health behaviors specific to each pair. There will be additional opportunities to demonstrate and apply learned concepts.
  • Participants: Newsletter — BEHAVIORAL
    Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.

Study Details

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).

Key Dates

Start date
Sep 2, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
1,024 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants: iAmHealthy
    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.
  • Active Comparator: Participants: Newsletter
    Families will receive a monthly newsletter for six months.

Primary Outcome Measure

Change from baseline to 6 months to year 4 in child body mass index (BMI) [ Time Frame: Baseline, 6 months, year 4 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Ann M Davis, PhD, MPH, ABPP
[email protected]
913-588-6323
Megan Olalde, MS, RD
[email protected]
913-588-2042
Ann M Davis, PhD, MPH, ABPP (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Ellen (El) K Kerns, PhD, MPH, CPH
[email protected]
(402) 955-6038
Samantha Beisel
[email protected]
Ellen (El) K Kerns, PhD, MPH, CPH (PRINCIPAL_INVESTIGATOR)
University Of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Paul M Darden, MS
[email protected]
405-637-5997
Paul M Darden, MD (PRINCIPAL_INVESTIGATOR)
Amanda L Bogie, MD, FAAP (SUB_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
James R Roberts, MD, MPH
[email protected]
843-876-8512
Shannon Cabaniss, MPH
[email protected]
James R Roberts, MD, MPH (PRINCIPAL_INVESTIGATOR)

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