Clinical trial NCT03165474: Intervention INC: Interactive Nutrition Comics for Urban Minority Youth
Official title: Intervention INC: Interactive Nutrition Comics for Urban Minority Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: childhood obesity
mhealth
digital health
nutrition
intervention
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: Children's Aid
name: Weill Medical College of Cornell University
First posted: 2017-05-24
Enrollment: 178
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: Child Inclusion Criteria:

* Identify as Black, African-American, and/or Hispanic/Latino
* age 9-12 years old by start of the intervention
* English-speaking
* either received care at the WCMC clinic or CAS Milbank clinic within the last 2 years -
* has BMI percentile at or above 5% as indicated in their electronic health record (based on CDC sex-specific BMI-for-age- growth chart)
* has regular internet access via tablet, smartphone, and/or computer/laptop
* has regular phone access with texting ability
* has no allergies, food aversions, food disorders, or medications with side-effects that impact diet/eating that would prevent participation in the study
* has a parent/guardian willing to participate in the study

Parent inclusion criteria:

* Parent or guardian of child that meets inclusions/exclusion criteria
* English- or Spanish-speaking
* has regular internet access via tablet, smartphone, and/or computer/laptop
* has regular phone access with texting ability
* willing and able to give permission for their child to participate in the study

Exclusion Criteria:

* Participants involved in Aim 1 or Aim 2 of study previously exposed to components of intervention

Primary outcomes:
measure: Usage - Child
timeFrame: Daily throughout study duration (~4.5 months)
measure: Usability - Child
timeFrame: T2 (after 3 weeks or halfway through the intervention) and T3 (after 6 weeks or at the end of the intervention)
measure: Context of Use - Child
timeFrame: T3 (after 6 weeks or at the end of the intervention)
Secondary outcomes:
measure: Change in child knowledge & attitudes - Child
timeFrame: T1 (baseline), T2 (after 3 weeks or halfway through the intervention), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
measure: Change in child dietary intake - Child
timeFrame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
measure: Change in BMI percentile - Child
timeFrame: T1 (baseline) and T4 (3 months post-intervention)
measure: Usage - Parent
timeFrame: Daily throughout study duration (~4.5 months)
measure: Change in parent feeding practices - Parent
timeFrame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
measure: Change in physical home food environment
timeFrame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
affiliation: Hunter College of City University of New York
name: May May Leung, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeFrank G, Singh S, Mateo KF, Harrison L, Rosenthal A, Gorman A, Leung MM. Key recruitment and retention strategies for a pilot web-based intervention to decrease obesity risk among minority youth. Pilot Feasibility Stud. 2019 Sep 5;5:109. doi: 10.1186/s40814-019-0492-8. eCollection 2019.
citation: Leung MM, Mateo KF, Verdaguer S, Wyka K. Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial. JMIR Res Protoc. 2018 Nov 9;7(11):e10682. doi: 10.2196/10682.