iAmHealthy Clinical Practice Guideline (CPG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorUniversity of Kansas Medical Center
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Participants: iAmHealthy
BehavioralFamilies 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
BehavioralFamilies assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.
Treatment groups
1,024 Participants
are divided into 2 treatment groupsGroup A: Participants: iAmHealthyExperimental treatment 1 intervention
Group B: Participants: NewsletterActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 6 months, year 42
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.
Time frame
Every six months for 3.5 yearsSecondary outcomes
1
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.
Time frame
Baseline, 6 months, year 42
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.
Time frame
Baseline, 6 months, year 43
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.
Time frame
Baseline, 6 months, year 44
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.
Time frame
Baseline, 6 months, year 4Other outcomes
1
Child/caregiver demographics and medical history/update
Age, race, ethnicity, income, insurance type (public/private), individuals living in the home, comorbidity conditions, rurality.
Time frame
Baseline, 6 months, year 42
Clinic: Qualitative interviews
Study team will conduct structured interviews with participating clinic staff to assess a series of structured questions regarding the barriers and facilitators of: 1. the Healthy Clinic intervention; 2. The iAmHealthy/Newsletter intervention; 3. other aspects of the study including measurement and communication. These interviews will be transcribed and analyzed using the accepted qualitative analysis techniques of Morgan and Krueger.
Time frame
Year 43
Clinic: Questionnaires for quality improvement
Questionnaires will collect quality improvement experience.
Time frame
Years 1 and 44
Clinic: Questionnaires for current policies/procedures
Questionnaires will collect current policies/procedures related to overweight and obesity.
Time frame
Years 1 and 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov