Clinical trial NCT04142034: Feasibility Trial of the iAMHealthy Intervention
Official title: Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity; Rurality
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-10-29
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This feasibility trial is a multisite, RCT with two parts. In part 1, sites will be randomized into the order in which two recruitment methods, traditional or consecutive, are used to recruit study participants. In part 2, recruited participants will be randomized to receive a newsletter or newsletter plus the iAmHealthy behavioral intervention.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Recruitment Rate
timeFrame: 1 month for each recruitment option plus a 1 month catch-up period
Secondary outcomes:
measure: Participant Retention
timeFrame: 6 months
measure: Change in Child Body Mass Index From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in Caregiver Body Mass Index From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in Daily Servings of Sweetened Drinks
timeFrame: 6 months
measure: Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention
timeFrame: 6 months
measure: Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention
timeFrame: 6 months
Other outcomes:
measure: Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention
timeFrame: 6 months
measure: Staff Blinding
timeFrame: 6 months
Locations:
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Kansas Medical Center
name: Ann Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Paul Darden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.