Actively Recruiting

Phase Not Applicable
Age: 8Years - 12Years
All Genders
Healthy Volunteers
NCT05935592

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

Led by Tufts University · Updated on 2025-04-10

200

Participants Needed

2

Research Sites

117 weeks

Total Duration

On this page

Sponsors

T

Tufts University

Lead Sponsor

C

Children's Aid, New York City

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child self-identifies as Black/African-American and/or Latino
  • Child is between 8 and 12 years old at baseline
  • Child reads and speaks English
  • Child has a Body Mass Index percentile at or above 5% at baseline
  • Child has regular internet access via tablet, smartphone, or computer/laptop
  • Child has regular access to a phone with texting capability
  • Child is comfortable reading/viewing material on electronic devices
  • Child is comfortable speaking with study staff during participation
  • Legal parent or guardian willing to participate in study
  • Parent or guardian reads and speaks English or Spanish
  • Parent or guardian is primarily responsible for preparing or purchasing food for the child
  • Parent or guardian has regular internet access via tablet, smartphone, or computer/laptop
  • Parent or guardian has regular access to a phone with texting capability
  • Parent or guardian is comfortable reading/viewing material on electronic devices
  • Parent or guardian is able to attend in-person visits and complete online questionnaires with the child throughout the study
Not Eligible

You will not qualify if you...

  • Child has allergies, food aversions, food disorders, or medications with side effects impacting study participation
  • Child has a pacemaker or heart condition
  • Child is in foster care

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Milbank Health Center - Children's Aid

New York, New York, United States, 10026

Actively Recruiting

2

Bronx Health Center - Children's Aid

The Bronx, New York, United States, 10460

Actively Recruiting

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Research Team

M

May May Leung, PhD, RDN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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