Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05935592

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Childhood

Full registry criteria

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

Treatments and study arms

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

Primary outcomes

Change in BMI z-scoreT1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)

BMI z-score calculation based on measured height and weight

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Milbank Health Center - Children's Aid🇺🇸 New York, New York, United States
Sophia Gigos-Costeas, MD, MPH, FAAPContact
Bronx Health Center - Children's Aid🇺🇸 The Bronx, New York, United States
Sophia Gigos-Costeas, MD, MPH, FAAPContact