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

Part of paid clinical trials in New York, New York.

Sponsor
Tufts University
Study ID
NCT05935592
Status
Recruiting
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Conditions

  • Obesity, Childhood

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Web-based comic and newsletters — BEHAVIORAL
    Web-based comic and health messages (child component) and health newsletters (parent component)
  • Didactic health information — BEHAVIORAL
    Web-based newsletters (for child and parent) by email and/or text

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Oct 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental Group
    The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
  • Active Comparator: Comparison Group
    The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.

Primary Outcome Measure

Change in BMI z-score [ Time Frame: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Milbank Health Center - Children's AidNew YorkNew York10026
Sophia Gigos-Costeas, MD, MPH, FAAP
[email protected]
646-883-5163
Bronx Health Center - Children's AidThe BronxNew York10460
Sophia Gigos-Costeas, MD, MPH, FAAP
[email protected]
646-883-5163

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By research site
Milbank Health Center - Children's Aid· New York, NYBronx Health Center - Children's Aid· The Bronx, NY

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