Clinical trial NCT05935592: Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
Official title: Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Children's Aid, New York City
name: Washington University School of Medicine
name: Agency for Healthcare Research and Quality (AHRQ)
name: Hunter College of City University of New York
name: City University of New York, School of Public Health
name: University of Massachusetts, Amherst
First posted: 2023-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in BMI z-score
timeFrame: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary outcomes:
measure: Change in child dietary intake
timeFrame: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
measure: Change in child dietary knowledge and attitudes
timeFrame: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
measure: Change in parent feeding practices
timeFrame: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
measure: Change in home food environment
timeFrame: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Health Center - Children's Aid
state: New York
city: New York
country: United States
facility: Milbank Health Center - Children's Aid
state: New York
Study officials:
References: