Intervention INC: Interactive Nutrition Comics for Urban Minority Youth
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The primary purpose of this study is to assess the feasibility and participant acceptability
      of an interactive, internet/mobile-enabled dietary self management intervention. The
      secondary purpose of this study is to determine if the intervention improves knowledge,
      attitudes and food preferences associated with the targeted behaviors, to reduce childhood
      obesity risk from baseline to post-test.
    

Detailed description: 
      Based on inclusion/exclusion criteria, potential study participants (child and parent) will
      be identified by the Collaborating Site PI/primary contact and sent a recruitment letter
      signed by the Primary Investigator and a Collaborating Site PI/primary contact.

      Children's Aid Society (CAS) and Weill Cornell Medical College (WCMC) will act as
      collaborating sites. WCMC PI is Dr. Allison Gorman, who will assist with identifying
      potential study participants from their government insured medical clinics. All recruitment
      protocols will be approved by the IRB at WCMC (pending Hunter IRB approval). Once the letter
      of approval has been received from WCMC, it will be forwarded to CUNY's HRPP. CAS primary
      contact is Alyson Abrami. Ms. Abrami and the CAS Milbank Medical Clinic will facilitate
      access to potential study participants. CAS is aware of the study protocols and the
      administration is in support of the study and its potential impact on their patient
      population.

      Study staff will contact potential study participants by phone and ask additional screening
      questions to determine study eligibility. A baseline in-person study visit will be scheduled
      for eligible participants. We are aiming to recruit a total of 82 child/parent dyads (41 in
      the intervention and control group, respectively). In the intervention group, children will
      have access to a web-based interactive nutrition comic and receive health messages from comic
      characters by email and/or text, while parents will receive weekly newsletters related to
      nutrition and health by email and/or text. In the control group, children and parents will
      receive didactic health information and resources by email and/or text. The delivery mode of
      the health messages will be based on based on personal preference.

      Aside from usage data of the online tool by each child/parent (e.g. average time spent per
      login using online tool, collected on an ongoing basis throughout 6-week intervention), data
      will be collected at four different times points in the study: baseline (T1), after 3 weeks
      or halfway through the intervention (T2-only children), after 6 weeks or at the end of the
      intervention (T3), and 3 months post-intervention (T4). T1 and T4 will be in-person study
      visits at either CUNY Hunter College or CAS Milbank. At baseline (T1), the child's height and
      weight will be measured to confirm meeting BMI eligibility criteria. After the child and
      parent completes consent/assent forms, they will be randomized to either the intervention
      group or control group. Both the child and parent will complete baseline survey measures
      (will take 20-30 minutes to complete) and attend a study orientation session (10-15 minutes).
      The baseline visit should take about 1 hour. At T2 (child-only) and T3 (child and parent),
      data collection (survey measures and open-ended questions) will be conducted either on the
      phone or by videochat in a private area, according to the participant preference, and will
      take approximately 30 minutes per person. At T4, the child's height and weight will be
      measured, and both the child and parent will complete survey measures (will take
      approximately 45 minutes to complete). Both the child and parent will be compensated for
      completing survey measures (see Participants-Compensation section for more details).

      Open-ended questions collected at timepoint T3 (over the phone or videochat) will be audio
      recorded (only intervention arm participants). Even though participants will have signed
      consent to be audio recorded during data collection, the participant will be asked during the
      phone call or videochat session at T3 if the following open-ended questions could be audio
      recorded to be reviewed in more detail afterwards. Additionally, open-ended questions related
      to the experience and context of using the web-based nutrition comic will be asked of a
      subset of parents and children (intervention arm only) at timepoint T3 (over the phone or
      videochat). Their responses will also be audio recorded as this is qualitative data that will
      be transcribed and analyzed separately from survey data.
    

Intervention name(s): Web-based comic and newsletters; Didactic health information
Intervention type(s): Other; Other
Intervention description(s): Web-based comic and health messages (child component) and health newsletters (parent component); Didactic health information and resources by email and/or text
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Keywords: childhood obesity; mhealth; digital health; nutrition; intervention