Feasibility Trial of the iAMHealthy Intervention
Condition: Obesity; Rurality
Study type: Interventional

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.
    

Intervention name(s): the iAmHealthy Behavioral Intervention; Newsletter only arm; Consecutive Recruitment; Traditional Recruitment
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): 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; Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise; Recruitment of study participants through identifying potential participants through their medical records; Recruitment of potential participants through flyers and advertisements
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary purpose: Other