Feasibility Trial of the iAMHealthy Intervention (iAmHealthy)

Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics

This research study is being done to find out which of 2 ways works best to get rural participants interested in joining a research study about children who weigh more than is considered healthy. One method researchers will use is the traditional method of reaching out to potential participants. The traditional method includes using flyers, posters, and booklets. The other method will be to target people who might be especially interested in the study. The second method uses medical records to find potential participants who are most likely to qualify for the study. This study is also being done to what works to help keep participants in a study like this.

Another goal of the study is to find out what methods work well to help get and keep children's and caregiver's weight in the healthy range. Researchers also want to see what works well to help children with a high Body Mass Index be more physically active and to eat healthier foods. The test methods researchers will use for this part of the study are (1) newsletters only and (2) newsletters plus online meetings. Participants will be randomly assigned to 1 of the 2 groups (newsletter or newsletter plus meetings.)

The newsletter-only group will receive monthly newsletters about children's health; this group will receive these letters for 6 months. The 'newsletter plus meeting group' will also receive the same monthly newsletter for 6 months. The latter group will also have online meetings with other children and adults as well as a group leader. Those in the 'newsletter plus meeting group' will also individually meet with a dietician.

This study will involve children and one of their caregivers (parent/guardian). The child and caregiver must live in a rural area. The child must be 6 to 11 years old. The child must be considered to have an unhealthy weight (high Body Mass Index). Both the child and caregiver must speak English. Up to 224 children will enter into this study. Participants will be consented through 4 different sites that are part of the IDeA States Pediatric Network.

Study Overview

• Status: Completed
• Conditions: Obesity; Rurality
• Intervention / Treatment: Behavioral: the iAmHealthy Behavioral Intervention; Behavioral: Newsletter only arm; Other: Consecutive Recruitment; Other: Traditional Recruitment

Detailed Description

Conduct a multisite feasibility trial for the iAmHealthy intervention with two randomized controlled recruitment options (consecutive recruitment and traditional recruitment). We will examine retention, dose, and blinding that will inform the development of a larger, treatment-outcome fully powered randomized controlled trial (RCT) of the iAmHealthy behavioral intervention in the IDeA States Pediatric Clinical Trials Network (ISPCTN).

The study team will perform the iAmHealthy trial will be performed in four ISPCTN site-awardee states. Specifically, the study team will perform the iAmHealthy trial in one clinic per state.

Randomization of recruitment options occurs at the clinic level. Each clinic, in a randomly ordered sequence, will implement two methods of recruitment. Recruitment of Participants, for more detail on the two methods of recruitment.

Randomization of participants into intervention arms will occur at the individual level.

Newsletter-only Intervention Arm

Child/caregiver pairs in the newsletter-only intervention arm will receive:

• usual care at their clinic for all issues, including overweight and obesity;
• a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period.

iAmHealthy Behavioral Intervention Arm

Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:

• usual care at their clinic for all issues, including overweight and obesity;
• a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);
• weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;
• 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician.

The iAmHealthy behavioral intervention psychologists/social worker will individualize group sessions and the iAmHealthy behavioral intervention dietician will adapt individual sessions by focusing on local cultural, religious, and ethnic factors relevant to the recommended changes in eating and activity habits. The iAmHealthy behavioral intervention includes 26 contact hours (15 hours of group sessions and 11 hours of individual sessions).

This feasibility trial will provide information toward the implementation of a fully powered, multisite, randomized behavior intervention trial that will compare the effectiveness of the iAmHealthy behavioral intervention to a newsletter-only intervention for the treatment of obesity among rural and underserved children and their primary caregivers.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours/Alfred I. duPont Hospital for Children
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • University of Nebraska Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • West Virginia
    • Morgantown, West Virginia, United States, 26330
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Child is rural. The child lives in a rural area, as defined by the United States Department of Agriculture (USDA) Rural Urban Commuting Area (RUCA) codes (greater than or equal to 4). We will calculate this using the 2010 Zip Code, RUCA Code crosswalk.
2. Child is ages 6-11 years at the time of consent. At the time of consent, a child must be 6 to 11 years of age. A narrow age range is necessary to decrease developmental variability. Clinics may enroll a child no earlier than her or his sixth birthday (6 years, 0 months, 0 days), and may enroll a child up to her or his 12th birthday (11 years, 11 months, 30 days).
3. Child BMI percentile is ≥85th. We will use the 85th percentile as a minimal cutoff for participation, as this is the minimal criteria for the definition of overweight. There is no upper limit on BMI percentile for inclusion.
4. Child and primary caregiver speak English. For the initial feasibility pilot, we will ask that both the child and primary caregiver speak English. For the larger trial that will follow, we will accommodate Spanish-speaking participants.

5. For the iAmHealthy behavioral intervention arm, the child and primary caregiver are available when the behavioral intervention team offers the intervention for the participating clinic. The child and primary caregiver must be available for most of the iAmHealthy behavioral intervention sessions when the behavioral intervention psychologist/social worker offers the group sessions at the participants' clinic. The behavioral team will conduct these sessions via video conference and families will attend via tablets.

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Exclusion Criteria:

1. 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. Because this trial recommends physical activity, we will exclude children who cannot comply with this health behavior.
2. Child has a known medical issue that could affect protocol compliance (e.g., cancer). If a child has a significant medical issue known to the clinic that could affect protocol compliance, we will exclude this child, as the protocol involves an intense intervention commitment.
3. Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance. We will exclude primary caregivers and/or children with a known developmental delay, as this could negatively affect participation and measurement completion.
4. Child is enrolled in a weight-loss trial. If a child is enrolled in a weight-loss trial, we will exclude the child to avoid cross-pollination of trial interventions.
5. Child has a sibling who has already enrolled in the trial. If multiple children from the same family attempt to enroll, the statistical team will randomly select one child for enrollment. We will always allow siblings to attend the intervention, but we will not officially enroll them.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iAmHealthy Behavioral Intervention; This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.	Behavioral: the iAmHealthy Behavioral Intervention; iAmHealthy Behavioral Intervention Arm Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive: usual care at their clinic for all issues, including overweight and obesity;; a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);; weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;; 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician
ACTIVE_COMPARATOR: NewsLetter intervention; This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.	Behavioral: Newsletter only arm; Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
OTHER: Consecutive Recruitment method; Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.	Other: Consecutive Recruitment; Recruitment of study participants through identifying potential participants through their medical records
OTHER: Traditional Recruitment method; Flyers, advertisements, and other materials will be used to recruit potential participants to the study.	Other: Traditional Recruitment; Recruitment of potential participants through flyers and advertisements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Recruitment Rate	Measure participant recruitment rate for both recruitment options	1 month for each recruitment option plus a 1 month catch-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention	Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.	6 months
Change in Child Body Mass Index From Baseline to Post-intervention	This measure is derived from subtracting the child body mass index (BMI) taken at baseline from the child BMI taken at the end of the intervention period	6 months
Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention	This measure is derived from subtracting the child BMIz taken at baseline from the child BMIz adjusted for age and sex at the end of the intervention period. The BMIz is the body mass index adjusted for sex and age, and is a z-score normalized for the mean and standard deviation of the body mass index for the child's age and sex. A BMI z-score over 1.96 indicates that the child's body mass index is above the 95th percentile for his/her age.	6 months
Change in Caregiver Body Mass Index From Baseline to Post-intervention	The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period	6 months
Change in Daily Servings of Sweetened Drinks	This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period	6 months
Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention	This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period	6 months
Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention	This measure shows the change in the number of red food servings consumed daily from baseline to after the intervention period. Red foods are defined as those with greater than or equal to 7 grams of fat and/or greater than or equal to 12 grams of sugar per serving.	6 months
Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention	The number of minutes spent in moderate to vigorous physical activity (MVPA) is measured using an activity monitor worn by the participant. This measure is the change in minutes in MVPA from baseline to after the intervention period	6 months
Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention	The denominator for this measure is the number of minutes that the participant is wearing the activity monitor. The % of moderate to vigorous physical time (MVPA) is the percent of that time that the participant is spent in moderate to vigorous physical activity. This measure describes the change in that percent of time from baseline to after intervention.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention	Participants who receive at least 80% of the planned intervention (dose) among those participants randomized to the iAmHealthy behavioral intervention arm who are retained through the final measurement.	6 months
Staff Blinding	Blinding index as described by Bang (Bang et cl. Assessment of blinding in clinical trials. Control Clin Trials 2004: 25(2):143-156. It ranges from -1 to 1 where a value of 0 indicates fully successful blinding; a value of 1 indicates lack of blinding meaning that individuals were able to correctly identify participants' assigned intervention, and -1 indicates that individuals typically guessed the incorrect assignment.	6 months

Collaborators and Investigators

• Sponsor: IDeA States Pediatric Clinical Trials Network
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ann Davis, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Davis AM, Darden PM, Snowden J, Simon AE, McCulloh RJ, Bimali M, Lee J. Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics: A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network. Contemp Clin Trials. 2021 Aug;107:106476. doi: 10.1016/j.cct.2021.106476. Epub 2021 Jun 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2020
• Primary Completion (ACTUAL): March 25, 2021
• Study Completion (ACTUAL): March 25, 2021

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 249932; U24OD024957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

We will conduct this trial in accordance with the following publication and data sharing policies and regulations:

• NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.
• ISPCTN Publications and Presentations Policy, which ensures accurate, responsible, and efficient communication of findings from ISPCTN clinical trials. The ISPCTN Steering Committee has approved and ratified the ISPCTN Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from the NIH and the DCOC.
• NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Other researchers my request data from this trial by contacting Jeannette Lee, PhD, at the DCOC.

• IPD Sharing Time Frame: Per data and sharing polices of National Institute of Health (NIH) and the IDeA States Pediatric Clinical Trials Network (ISPCTN).
• IPD Sharing Access Criteria: To be announced (TBA)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No