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

Primary Purpose

Obesity, Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based comic and newsletters
Didactic health information
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria (child): self-identifies as Black/African-American and/or Latino between ages 9 and 12 years (preadolescents) at time of scheduled baseline visits reads and speaks in English has a Body Mass Index percentile at or above 85% at baseline (categorized as 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Comparison Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in BMI z-score
    BMI z-score calculation based on measured height and weight

    Secondary Outcome Measures

    Change in child dietary intake
    17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days
    Change in child dietary knowledge and attitudes
    45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks
    Change in parent feeding practices
    27-item questionnaire completed by parent participants assessing multiple parental feeding practices
    Change in home food environment
    6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    June 29, 2023
    Sponsor
    Hunter College of City University of New York
    Collaborators
    Children's Aid, CUNY Graduate School of Public Health and Health Policy, Brown School at the Washington University of St. Louis, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05935592
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hunter College of City University of New York
    Collaborators
    Children's Aid, CUNY Graduate School of Public Health and Health Policy, Brown School at the Washington University of St. Louis, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 mailed letters, direct calls, and in-person/flyer-based recruitment in clinic waiting rooms. 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), BMI category (overweight, obese), gender (male, female, other), 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 intervention will be individually tailored based upon an initial self-assessment tailoring algorithm of the participating child-parent dyad. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
    Arm Title
    Comparison Group
    Arm Type
    Active Comparator
    Arm Description
    The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Web-based comic and newsletters
    Intervention Description
    Web-based comic and health messages (child component) and health newsletters (parent component)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Didactic health information
    Intervention Description
    Web-based newsletters (for child and parent) by email and/or text
    Primary Outcome Measure Information:
    Title
    Change in BMI z-score
    Description
    BMI z-score calculation based on measured height and weight
    Time Frame
    T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
    Secondary Outcome Measure Information:
    Title
    Change in child dietary intake
    Description
    17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days
    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)
    Title
    Change in child dietary knowledge and attitudes
    Description
    45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks
    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)
    Title
    Change in parent feeding practices
    Description
    27-item questionnaire completed by parent participants assessing multiple parental 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)
    Title
    Change in home food environment
    Description
    6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria (child): self-identifies as Black/African-American and/or Latino between ages 9 and 12 years (preadolescents) at time of scheduled baseline visits reads and speaks in English has a Body Mass Index percentile at or above 85% at baseline (categorized as 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    May May Leung, PhD, RDN
    Phone
    212.396.7774
    Email
    maymay.leung@hunter.cuny.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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