Feasibility Trial of the iAMHealthy Intervention

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

Interventions

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

BEHAVIORAL

Newsletter only arm

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

OTHER

Consecutive Recruitment

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

OTHER

Traditional Recruitment

Recruitment of potential participants through flyers and advertisements

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• IDeA States Pediatric Clinical Trials Network

  lead NETWORK

Principal Investigators

• Ann Davis, PhD · University of Kansas Medical Center

• Paul Darden, MD · University of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-03

Primary Completion

2021-03-25

Completion

2021-03-25

Countries

• United States

Study Locations