Intervention INC: Interactive Nutrition Comics for Urban Minority Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-11

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Participants will be randomized into intervention or control arm and will be provided with different orientations.

Study Groups

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Control Arm

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.

Group Type ACTIVE_COMPARATOR

Didactic health information

Intervention Type OTHER

Didactic health information and resources by email and/or text

Intervention Arm

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.

Group Type EXPERIMENTAL

Web-based comic and newsletters

Intervention Type OTHER

Web-based comic and health messages (child component) and health newsletters (parent component)

Interventions

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Web-based comic and newsletters

Web-based comic and health messages (child component) and health newsletters (parent component)

Intervention Type OTHER

Didactic health information

Didactic health information and resources by email and/or text

Intervention Type OTHER

Eligibility Criteria

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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

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

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No