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

Not Applicable

Not yet recruiting

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Web-based comic and newsletters; Behavioral: Didactic health information

• Registration Number: NCT05935592
• Lead Sponsor: Tufts University

Brief Summary

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

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 in-person/flyer-based recruitment in clinic waiting rooms, healthcare provider referrals, and direct calls.

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), child biological sex (male, female), 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 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.

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Start: 2024-06
• Primary Completion: 2025-06
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Web-based comic and newsletters	The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
Comparison Group	Didactic health information	The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in child dietary intake	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)	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
Change in child dietary knowledge and attitudes	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)	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
Change in parent 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)	27-item questionnaire completed by parent participants assessing multiple parental feeding practices
Change in home food environment	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)	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