Feasibility Trial of the iAMHealthy Intervention

NCT04142034 | Completed Results DMC

• 2 other identifiers: 249932U24OD024957
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 4

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.

Conditions

Obesity; Rurality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Participant Retention

  6 months

• Change in Child Body Mass Index From Baseline to Post-intervention

  6 months

• Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention

  6 months

• Change in Caregiver Body Mass Index From Baseline to Post-intervention

  6 months

• Change in Daily Servings of Sweetened Drinks

  6 months

Other Outcomes (2)

• Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention

  6 months

• Staff Blinding

  6 months

Study Arms (4)

iAmHealthy Behavioral Intervention

EXPERIMENTAL

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

NewsLetter intervention

ACTIVE COMPARATOR

This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.

Behavioral: Newsletter only arm

Consecutive Recruitment method

OTHER

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

Traditional Recruitment method

OTHER

Flyers, advertisements, and other materials will be used to recruit potential participants to the study.

Other: Traditional Recruitment

Interventions

the iAmHealthy Behavioral Intervention BEHAVIORAL

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

iAmHealthy Behavioral Intervention

Newsletter only arm BEHAVIORAL

Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise

NewsLetter intervention

Consecutive Recruitment OTHER

Recruitment of study participants through identifying potential participants through their medical records

Consecutive Recruitment method

Traditional Recruitment OTHER

Recruitment of potential participants through flyers and advertisements

Traditional Recruitment method

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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).
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• IDeA States Pediatric Clinical Trials Network: lead
• National Institutes of Health (NIH): collaborator

Study Sites (4)

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

West Virginia University

Morgantown, West Virginia, 26330, United States

Location

Related Publications (4)

• 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.

  PMID: 34118426 BACKGROUND

• Zhang E, Davis AM, Jimenez EY, Lancaster B, Serrano-Gonzalez M, Chang D, Lee J, Lai JS, Pyles L, VanWagoner T, Darden P. Validation of remote anthropometric measurements in a rural randomized pediatric clinical trial in primary care settings. Sci Rep. 2024 Jan 3;14(1):411. doi: 10.1038/s41598-023-50790-1.

  PMID: 38172325 DERIVED

• Nguyen L, Phan TL, Falini L, Chang D, Cottrell L, Dawley E, Hockett CW, VanWagoner T, Darden PM, Davis AM. Rural Family Satisfaction With Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics. Child Obes. 2024 Apr;20(3):147-154. doi: 10.1089/chi.2022.0210. Epub 2023 Apr 10.

  PMID: 37036783 DERIVED

• Darden PM 2nd, Davis AM, Lee JY, Bimali M, Simon AE, Atz AM, Lim CS, Phan TT, Roberts JR, McCulloh RJ, Pyles L, Shaffer M, Snowden JN. Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2244040. doi: 10.1001/jamanetworkopen.2022.44040.

  PMID: 36445709 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jeannette Lee
• Organization: University of Arkansas for Medical Sciences

jylee@uams.edu

5015266712

Study Officials

• Ann Davis, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Darden, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Each clinics will recruit up to 28 child/caregiver pairs.The site awardee investigators will be blinded. The site awardee investigator will also identify a back-up,research-trained blinded assessor from the awardee site. The blinded coordinator will not have access to clinic charts. The clinic coordinator will instruct participants not discuss the trial or previous weights/data collected. He or she, or the designated backup, will take the height and weight measurements at baseline and six months. In case the ISPCTN site-awardee coordinator is accidentally unblinded, the backup assessor will take over all assessments for that participant. At each measurement time point, the blinded assessor will enter data into the electronic data capture system only for that time point-the system will blind them to data from any/all other data-collection time points. The blinded site coordinator will perform the 24-hour food recalls at recruitment and six months.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: February 3, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: September 13, 2022
• Results First Posted: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Per data and sharing polices of National Institute of Health (NIH) and the IDeA States Pediatric Clinical Trials Network (ISPCTN).
• Access Criteria: To be announced (TBA)

Locations

US (4)