Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
2 other identifiers
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 10, 2025
October 1, 2024
2.3 years
June 29, 2023
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in BMI z-score
BMI z-score calculation based on measured height and weight
T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary Outcomes (4)
Change in child dietary intake
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
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
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
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Study Arms (2)
Experimental Group
EXPERIMENTALThe experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
Comparison Group
ACTIVE COMPARATORThe comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.
Interventions
Web-based comic and health messages (child component) and health newsletters (parent component)
Web-based newsletters (for child and parent) by email and/or text
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- Children's Aid, New York Citycollaborator
- Washington University School of Medicinecollaborator
- Agency for Healthcare Research and Quality (AHRQ)collaborator
- Hunter College of City University of New Yorkcollaborator
- City University of New York, School of Public Healthcollaborator
- University of Massachusetts, Amherstcollaborator
Study Sites (2)
Milbank Health Center - Children's Aid
New York, New York, 10026, United States
Bronx Health Center - Children's Aid
The Bronx, New York, 10460, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 7, 2023
Study Start
February 27, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 10, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share