Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Study Overview
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Brief Summary
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Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.

Detailed Description
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Childhood obesity continues to be a serious clinical and public health issue in the United States (US), particularly within low-income, minority groups. Effective, yet engaging interventions, such as the one developed by our team, are needed to capture the attention of children living in a multi-media environment. Potentially eligible pediatric patients (and their parent/caregiver) will be recruited from two of Children's Aid community-based clinics in NYC - Dunlevy Milbank Center based in Harlem and the Bronx Health Center based in the South Bronx. A variety of recruitment methods will be deployed, including mailed letters, direct calls, and in-person/flyer-based recruitment in clinic waiting rooms. At baseline, eligible participants will be randomized to either the experimental group or comparison group (allocation ratio 1:1). Randomization will be performed at the dyad level and will be balanced on child ethnicity (Hispanic or Non-Hispanic), BMI category (overweight, obese), gender (male, female, other), and clinic site. The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. The intervention will be individually tailored based upon an initial self-assessment tailoring algorithm of the participating child-parent dyad. The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. To minimize bias, participants will be blinded to the study's hypothesis. Data will be collected at four timepoints: baseline (T1), main intervention end (T2), maintenance intervention end (T3), and at 12-month follow-up (T4). The primary outcome measure (BMI z-score) will be calculated using height and weight data captured via combined scale/stadiometer by a trained healthcare provider at T1, T3, T4. Secondary measures (dietary intake and dietary knowledge & attitudes of child participants; feeding practices and the home food environment by the parent/caregiver) will be captured via questionnaires at T1, T2, T3, T4.

Official Title
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Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Web-based comic and newsletters
* Behavioral: Didactic health information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (child): self-identifies as Black/African-American and/or Latino between ages 9 and 12 years (preadolescents) at time of scheduled baseline visits reads and speaks in English has a Body Mass Index percentile at or above 85% at baseline (categorized as overweight or obese) has regular internet access via a tablet device, smartphone, or computer/laptop has regular access to a phone with texting capability is comfortable reading/viewing material on electronic devices is comfortable speaking with study staff about thoughts/experiences while participating in study has a legal parent/guardian willing to participate in study Inclusion Criteria (parent): legal parent/guardian of child willing to participate in study reads and speaks in English or Spanish primarily responsible for preparing/purchasing food for child has regular internet access via a tablet device, smartphone, or computer/laptop has regular access to a phone with texting capability comfortable reading/viewing material on electronic devices able to attend in-person study visits and complete online questionnaires with their child over the full duration of study Exclusion Criteria (child): has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study has a pacemaker or heart condition in foster care

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. | Behavioral: Web-based comic and newsletters<br>* Web-based comic and health messages (child component) and health newsletters (parent component)<br>|
| Active Comparator: Comparison Group<br>The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. | Behavioral: Didactic health information<br>* Web-based newsletters (for child and parent) by email and/or text<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z-score | BMI z-score calculation based on measured height and weight | T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child dietary intake | 17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days | T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) | 
| Change in child dietary knowledge and attitudes | 45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks | T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) | 
| Change in parent feeding practices | 27-item questionnaire completed by parent participants assessing multiple parental feeding practices | T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) | 
| Change in home food environment | 6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child | T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) |