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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intervention INC: Interactive Nutrition Comics for Urban Minority Youth

NCT03165474

Obesity, Childhood

COMPLETED NA

Packaging and Disseminating the JOIN for ME Program in Low-Income Settings

NCT04647760

Pediatric Obesity

COMPLETED NA

A Community-based Study to Target Childhood Obesity

NCT02890056

Obesity

COMPLETED NA

An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

NCT01552642

Child Obesity Overweight

COMPLETED PHASE3

Family Intervention to Prevent Childhood Obesity

NCT05606731

Childhood Obesity

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.

Group Type EXPERIMENTAL

Web-based comic and newsletters

Intervention Type BEHAVIORAL

Web-based comic and health messages (child component) and health newsletters (parent component)

Comparison Group

The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.

Group Type ACTIVE_COMPARATOR

Didactic health information

Intervention Type BEHAVIORAL

Web-based newsletters (for child and parent) by email and/or text

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Web-based comic and newsletters

Web-based comic and health messages (child component) and health newsletters (parent component)

Intervention Type BEHAVIORAL

Didactic health information

Web-based newsletters (for child and parent) by email and/or text

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes