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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Web-based comic and newsletters; Behavioral: Didactic health information

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: May May Leung, PhD, RDN; Phone Number: 617-636-3676; Email: maymay.leung@tufts.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10460
      • Recruiting
      • Bronx Health Center - Children's Aid
      • Contact: Sophia Gigos-Costeas, MD, MPH, FAAP; Phone Number: 646-883-5163; Email: projectgameon@tufts.edu
    • New York, New York, United States, 10026
      • Recruiting
      • Milbank Health Center - Children's Aid
      • Contact: Sophia Gigos-Costeas, MD, MPH, FAAP; Phone Number: 646-883-5163; Email: projectgameon@tufts.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (child):

• self-identifies as Black/African-American and/or Latino
• between ages 8 and 12 years (preadolescents) at time of scheduled baseline visits
• reads and speaks in English
• has a Body Mass Index percentile at or above 5% at baseline (categorized as healthy, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Web-based comic and newsletters; Web-based comic and health messages (child component) and health newsletters (parent component)
Active Comparator: Comparison Group; The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.	Behavioral: Didactic health information; Web-based newsletters (for child and parent) by email and/or text

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Washington University School of Medicine; University of Massachusetts, Amherst; Agency for Healthcare Research and Quality (AHRQ); Hunter College of City University of New York; City University of New York, School of Public Health; Children's Aid, New York City

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: STUDY00004065; 5R01HS028650-03 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No