Intervention INC: Interactive Nutrition Comics for Urban Minority Youth

Obesity, Childhood Clinical Trial

Official title:

Intervention INC: Interactive Nutrition Comics for Urban Minority Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165474
• Other study ID #: HunterCCUNY
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Web-based comic and newsletters
Web-based comic and health messages (child component) and health newsletters (parent component)
• Didactic health information
Didactic health information and resources by email and/or text

Locations

Country	Name	City	State
United States	Hunter College	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Hunter College of City University of New York	Children's Aid, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage - Child	Usage analytics measured at the individual-level: min, max, average logins per day/week; min, max, average time spent on website per login; min, max, average link clicks per session (links to unique website areas)	Daily throughout study duration (~4.5 months)
Primary	Usability - Child	Survey measure to assess usability, usefulness, ease of use, ease of learning, and satisfaction (taken from SUS, USE, and SUPR-Q survey)	T2 (after 3 weeks or halfway through the intervention) and T3 (after 6 weeks or at the end of the intervention)
Primary	Context of Use - Child	Open-ended questions regarding experience and context using the web app, as well as acceptability and satisfaction	T3 (after 6 weeks or at the end of the intervention)
Secondary	Change in child knowledge & attitudes - Child	Survey measuring change in child knowledge, self-efficacy, preferences, and outcome expectancies related to eating fruits/vegetables and consuming water	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)
Secondary	Change in child dietary intake - Child	Survey measuring change in child intake of specified fruits/vegetables, and water	T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Secondary	Change in BMI percentile - Child	Change in BMI percentile calculated based on measured height and weight	T1 (baseline) and T4 (3 months post-intervention)
Secondary	Usage - Parent	Usage analytics measured at the individual-level: min, max, average logins per day/week; min, max, average time spent on website per login; min, max, average link clicks per session (links to unique website areas)	Daily throughout study duration (~4.5 months)
Secondary	Change in parent feeding practices - Parent	Survey measuring child involvement, parent encouragement, parent modeling, and parent instruction about fruits/vegetables and water intake	T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Secondary	Change in physical home food environment	Survey measuring home availability and accessibility of fruits/vegetables and water	T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)