Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Web-based comic and newsletters, Didactic health information.
- Who it may be relevant to
- Registry conditions: Obesity, Childhood. Basic parameters: 8 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Web-based comic and newsletters
Web-based comic and health messages (child component) and health newsletters (parent component) - Behavioral Didactic health information
Web-based newsletters (for child and parent) by email and/or text
Primary outcome measures
- Change in BMI z-score [Time frame: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)]
Secondary outcome measures (4)
- Change in child dietary intake [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Milbank Health Center - Children's Aid — New York
- Bronx Health Center - Children's Aid — The Bronx
Identifiers
NCT: NCT05935592 · STUDY00004065 · 5R01HS028650-03