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Intervention INC: an interactive family-centered mHealth tool to reduce obesity risk in urban minority preadolescents

NCT ID NCT05935592

NEW Sponsor: Tufts University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Feb 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity, childhood

Contacts and locations

Locations

  • Bronx Health Center - Children's Aid

    The Bronx, New York, 10460, United States

  • Milbank Health Center - Children's Aid

    New York, New York, 10026, United States

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