Pediatric ObesityNCT06888011
iAmHealthy Clinical Practice Guideline (CPG)
A study testing Participants: iAmHealthy and Participants: Newsletter in people with Pediatric Obesity and Rural Health, run by University of Kansas Medical Center at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Pediatric Obesity, Rural Health, Clinical Practice Guideline
- What is being tested?
- Participants: iAmHealthy and Participants: Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Sep 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is ages 6-11 years at consent
- Child BMI %ile is ≥85th
- Child lives in a rural area
- Child/family speaks English or Spanish
- History of collaboration with site awardee in research or quality improvement projects
- In the past year at least 300 eligible potential participants
- The clinic must have an electronic medical records system
Who cannot join
- Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility
- 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
- Child is enrolled in a weight-loss trial
- Child has a sibling who has already consented in the trial
- Unable to generate lists of children seen in clinic by date of visit, age, and zip code
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
James R Roberts, MD, MPH, 843-876-8512, robertsj@musc.edu
Shannon Cabaniss, MPH, smw207@musc.edu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Ann M Davis, PhD, MPH, ABPP, 913-588-6323, adavis6@kumc.edu
Megan Olalde, MS, RD, 913-588-2042, molalde@kumc.edu
- Recruiting
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Paul M Darden, MS, 405-637-5997, paul-darden@ouhsc.edu
Paul M Darden, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Ellen (El) K Kerns, PhD, MPH, CPH, (402) 955-6038, ellen.kerns@unmc.edu
Samantha Beisel, sbeisel@unmc.edu
About this study
Official title: Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical 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).
Read the detailed description
Obesity poses a major health risk, contributing to elevated morbidity and mortality from cancer, cardiovascular disease, and diabetes. Children living in rural areas have higher rates of obesity than their urban counterparts. Based upon our extensive prior work, the investigators propose a multilevel factorial design randomized controlled trial with interventions at the clinic and individual patient level to treat pediatric obesity among underserved rural children and families. The individual intervention is an mHealth rurally tailored pediatric obesity behavioral intervention (iAmHealthy) vs. Newsletter control while the clinic-level intervention is a cluster randomized stepped wedge (Healthy Clinic intervention) designed to improve clinics' treatment of children with overweight and obesity. 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. The Healthy Clinic intervention is designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback targeted at the implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. This intervention is a site-level quality improvement implementation, not a participant-facing intervention.
This study will be the first to assess both clinic level and patient level pediatric obesity interventions tailored to the unique barriers in rural pediatric populations. Four states (KS, NE, OK, SC), who are members of the ECHO IDeA State Pediatric Clinical Trials Network (ISPCTN) and participated in a previous feasibility study of the iAmHealthy intervention (NCT04142034) in rural medical clinics have each recruited four medical clinics who care for rural children. In each rural clinic, investigators will recruit up to 64 caregiver/child dyads who will be randomly assigned to iAmHealthy or Newsletter, for a total of 512 child/caregiver dyads. The current proposal studies two easily disseminable multilevel interventions and their combination to address modifiable risk factors for cancer in rural populations, specifically pediatric obesity. These findings could significantly change the way medical clinics care for the 41% of rural children who are overweight or obese.
- Conditions
- Pediatric Obesity, Rural Health, Clinical Practice Guideline
- Being tested
- Participants: iAmHealthy, Participants: Newsletter
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants: iAmHealthyBehavioural
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: NewsletterBehavioural
Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.
| Study group | Role | What they receive |
|---|---|---|
| Participants: iAmHealthy | Experimental | 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. Receives: Behavioral: Participants: iAmHealthy |
| Participants: Newsletter | Active comparator | Families will receive a monthly newsletter for six months. Receives: Behavioral: Participants: Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 months to year 4 in child body mass index (BMI)
Height and weight will be collected remotely and used to calculate BMI, BMIz, BMI%ile and BMI%95th%ile.
Measured: Baseline, 6 months, year 4
Clinic: Independent clinic chart audit
The primary outcome measure for the Healthy Clinics intervention will be a random audit of 40 medical records in each clinic every 6 months performed by highly trained research staff in each state who are fully independent of the participating medical clinic. The medical record, index visit and latest well visit (within that 6 months), will be audited for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, followup plan, and counseling for diet and activity. The purpose of the clinic chart audit is to assess the clinic's current activities around identification and treatment of overweight and obesity.
Measured: Every six months for 3.5 years
Secondary outcomes (8)
Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign
The Exercise Vital Sign (EVS) is a modification of the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity (PA) questions, and its development was supported by PA experts as part of the Exercise is Medicine effort in the United States. EVS assesses the average time spent exercising by multiplying responses on 2 self-reported questions. Responses are multiplied to display minutes per day of moderate or strenuous exercise.
Measured: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child physical activity using the "moderate to vigorous physical activity" screening measure
The "moderate to vigorous physical activity" screening measure is a 2-item parent reported measure.
Measured: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child physical activity using the PROMIS Parent Proxy Physical Activity Measure
The PROMIS Parent Proxy Physical Activity Measure will measure how often parents report in the past 7 days that their child engaged in various physical activity.
Measured: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child dietary behavior
Child dietary behavior will be assessed with the Children's Eating Habits Questionnaire food frequency section (CEHQ-FFQ). The CEHQ-FFQ was designed to estimate the eating behaviors and intakes for each of the major food groups related to general health status and childhood obesity. A conversion factor is used to transform child dietary intake and fast-food consumption into weekly consumption frequencies, ranging from 0 to 25 and 0 to 8, respectively.
Measured: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child sleep
Child sleep will be assessed with the Children's Sleep Habits Questionnaire (CSHQ). This 22-item questionnaire has 9 questions about bedtime, 7 questions about sleep behavior, 2 questions about waking at night, and 4 questions about morning wake up. The measure results in a score of overall sleep quality, with scores over 41 indicating sleep problems.
Measured: Baseline, 6 months, year 4
Parent and child satisfaction of intervention and technology
The child satisfaction measure was developed specifically for the current study and will shadow the parent satisfaction items. Specific to technology, the investigators will also administer the 12-item Parent-Reported Satisfaction Measure, assessing three technology-related satisfaction domains: technical, comfort with technology and perceived privacy, and access.
Measured: 6 months
Change from baseline to 6 months to year 4 in caregiver body mass index (BMI)
Height and weight will be collected remotely and used to calculate BMI.
Measured: Baseline, 6 months, year 4
Clinic: Internal clinic chart audit
As a measure of interim progress in the Healthy Clinic intervention, clinic staff will conduct monthly audits of their own patient medical records for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, and counseling for diet and activity. Each audit will include 10 of the most recently seen patients 6-11 years of age who have overweight or obesity. Additional items will be added to assess the individual clinics' ongoing QI process. This will occur only while clinics are in the Healthy Clinics Intervention.
Measured: Every month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start2 Sep 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a multilevel factorial individually and cluster randomized stepped wedge design RCT with interventions targeted to the individual patient level (iAmHealthy vs. Newsletter) and to the clinic (Healthy Clinics). Healthy Clinics is a site-level quality improvement implementation to support providers and workflow, not a participant-facing intervention.
- Masking
- None (open label)
- Enrolment
- 1,024 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ann Davis, PhD, MPH, ABPP, Principal investigator, University of Kansas Medical CenterPaul M Darden, MD, Principal investigator, The University Of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888011
- Sponsor's protocol ID
- STUDY00160797
- Other IDs
- R01NR021278
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06888011
- Acronym / sponsor ID
- STUDY00160797
- Conditions
- Pediatric Obesity, Rural Health, Clinical Practice Guideline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,024 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Obesity poses a major health risk, contributing to elevated morbidity and mortality from cancer, cardiovascular disease, and diabetes. Children living in rural areas have higher rates of obesity than their urban counterparts. Based upon our extensive prior work, the investigators propose a multilevel factorial design randomized controlled trial with interventions at the clinic and individual patient level to treat pediatric obesity among underserved rural children and families. The individual intervention is an mHealth rurally tailored pediatric obesity behavioral intervention (iAmHealthy) vs. Newsletter control while the clinic-level intervention is a cluster randomized stepped wedge (Healthy Clinic intervention) designed to improve clinics' treatment of children with overweight and obesity. 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. The Healthy Clinic intervention is designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback targeted at the implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. This intervention is a site-level quality improvement implementation, not a participant-facing intervention.
This study will be the first to assess both clinic level and patient level pediatric obesity interventions tailored to the unique barriers in rural pediatric populations. Four states (KS, NE, OK, SC), who are members of the ECHO IDeA State Pediatric Clinical Trials Network (ISPCTN) and participated in a previous feasibility study of the iAmHealthy intervention (NCT04142034) in rural medical clinics have each recruited four medical clinics who care for rural children. In each rural clinic, investigators will recruit up to 64 caregiver/child dyads who will be randomly assigned to iAmHealthy or Newsletter, for a total of 512 child/caregiver dyads. The current proposal studies two easily disseminable multilevel interventions and their combination to address modifiable risk factors for cancer in rural populations, specifically pediatric obesity. These findings could significantly change the way medical clinics care for the 41% of rural children who are overweight or obese.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a multilevel factorial individually and cluster randomized stepped wedge design RCT with interventions targeted to the individual patient level (iAmHealthy vs. Newsletter) and to the clinic (Healthy Clinics). Healthy Clinics is a site-level quality improvement implementation to support providers and workflow, not a participant-facing intervention.
| Arm | Type | Receives |
|---|---|---|
| Participants: iAmHealthy | Experimental | Behavioral: Participants: iAmHealthyThe 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. |
| Participants: Newsletter | Active comparator | Behavioral: Participants: NewsletterFamilies will receive a monthly newsletter for six months. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child is ages 6-11 years at consent
- Child BMI %ile is ≥85th
- Child lives in a rural area
- Child/family speaks English or Spanish
- History of collaboration with site awardee in research or quality improvement projects
Key exclusion criteria (6 listed)
- Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility
- 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
- Child is enrolled in a weight-loss trial
- Child has a sibling who has already consented in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants: iAmHealthyFamilies 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. | Behavioural | Participants: iAmHealthy |
| Participants: NewsletterFamilies assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months. | Behavioural | Participants: Newsletter |
Primary outcome
Change from baseline to 6 months to year 4 in child body mass index (BMI)
Time frame: Baseline, 6 months, year 4
Height and weight will be collected remotely and used to calculate BMI, BMIz, BMI%ile and BMI%95th%ile.
Clinic: Independent clinic chart audit
Time frame: Every six months for 3.5 years
The primary outcome measure for the Healthy Clinics intervention will be a random audit of 40 medical records in each clinic every 6 months performed by highly trained research staff in each state who are fully independent of the participating medical clinic. The medical record, index visit and latest well visit (within that 6 months), will be audited for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, followup plan, and counseling for diet and activity. The purpose of the clinic chart audit is to assess the clinic's current activities around identification and treatment of overweight and obesity.
8 secondary outcomes
Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign
Time frame: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child physical activity using the "moderate to vigorous physical activity" screening measure
Time frame: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child physical activity using the PROMIS Parent Proxy Physical Activity Measure
Time frame: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child dietary behavior
Time frame: Baseline, 6 months, year 4
Change from baseline to 6 months to year 4 in child sleep
Time frame: Baseline, 6 months, year 4
Parent and child satisfaction of intervention and technology
Time frame: 6 months
Change from baseline to 6 months to year 4 in caregiver body mass index (BMI)
Time frame: Baseline, 6 months, year 4
Clinic: Internal clinic chart audit
Time frame: Every month for 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Davis, PhD, MPH, ABPP principal investigator
University of Kansas Medical Center
Paul M Darden, MD principal investigator
The University Of Oklahoma Health Sciences Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants: iAmHealthy and Participants: Newsletter in people with Pediatric Obesity and Rural Health, run by University of Kansas Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann M Davis, PhD, MPH, ABPP (913-588-6323, adavis6@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.