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A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children

Primary Purpose

Childhood Obesity, Parenting, Mobile Phone Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
healthy weight behaviors supported by web-based mobile phone application
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult male or female caregiver
  • self-identifies as an individual of Latino descent
  • has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian)
  • lives with or cares for child/grandchild at least 20 hours/week
  • is fluent in English or Spanish
  • has the ability to participate in the mHealth intervention (ability determined by using a Subject Comprehension and Participation Assessment Tool)
  • agrees to complete baseline, 1-, and 6-month post-baseline surveys and have adult and child height and weight measured.

Exclusion Criteria:

  • child has a failure to thrive diagnosis
  • medical complications associated with their weight status such as Prader-Willi Syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Mobile Phone Obesity Intervention

    Control

    Arm Description

    Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. Approximately 30 caregiver-child dyads will be randomized into the intervention arm. Every week for 4 weeks, caregivers will receive 4 interactive multi-media phone prompts to support the intervention's targeted topics. Each mobile phone prompt starts with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share their goal/s, perceived barriers, questions, tips and strategies that may be helpful to other participants. Each week, caregivers will also receive strategies, and individual and group feedback on changing unhealthy behaviors. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week.

    Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. Approximately 30 caregiver-child dyads will be randomized into the control (no intervention) arm. Every week for 4 weeks, these caregivers will receive 4 interactive multi-media phone prompts around managing common illness in young children (i.e. fever, vomiting, constipation, etc.) Each mobile phone prompt will start with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share questions and strategies that may be helpful to other participants. Each week, caregivers will also receive tips and group feedback based on group questions. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.

    Outcomes

    Primary Outcome Measures

    Child BMI (BMI=kg/m2)
    Child BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer

    Secondary Outcome Measures

    caregiver BMI (BMI=kg/m2)
    Caregiver BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer
    Children's Dietary Behaviors
    Children's Dietary Questionnaire (29-item instrument) measures a child's average consumption of 4 categories of foods or beverages. The 4 categories are further divided into 4 separate scores: a fruits and vegetables score, a fat from dairy products score, a sweetened beverage score, and a noncore food. Items are measured by participants responding to frequency/counts or using a likert scale. There are cutoffs provided for each score of the 4 categories. Overall, the higher the score in the fruits and vegetable sections the healthier the dietary behavior and the higher the score on dairy from fat and noncore foods the unhealthier the diet. score
    Child media-viewing behaviors
    Home Environment Inventory Survey: measures hours of watching TV, DVDs or Computer using two questions with responses including hours spent from three time categories throughout the day. The higher the number of hours reported the unhealthier the media-viewing behavior.
    Child physical activity behaviors
    Outdoor Playtime Checklist : the items on the scale ask two questions with responses from five time interval categories that are coded 0 through 4. The ordered categorical responses and summing the responses across both questions gives a maximum score of 24. The higher the score the more time spent playing outdoors.

    Full Information

    First Posted
    February 3, 2020
    Last Updated
    February 10, 2020
    Sponsor
    University of California, Los Angeles
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04261985
    Brief Title
    A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
    Official Title
    A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    February 1, 2021 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    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
    To pilot a stand-alone mobile phone intervention with Latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's BMI changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months post-baseline, in preparation for a larger randomized trial to evaluate the intervention's efficacy.
    Detailed Description
    The investigators will pilot an mHealth intervention using a prospective control group design with 66 caregiver-child dyads (33 intervention and 33 comparison) recruited from two community based agencies in East Los Angeles. Fidelity and feasibility will be assessed. Pre- and post- intervention data (child dietary, physical activity, and media viewing behaviors and BMI z-scores) will be collected to estimate preliminary effect sizes and standard deviations. The mHealth intervention has been informed by a previous feasibility study and focus groups with Latino caregivers of 2- to 5-year old children. This mHealth childhood obesity intervention specifically targets Latino mothers, fathers, and grandmothers of 2- to 5-year olds. The intervention focuses on parenting skills, dietary, physical activity, and media-viewing behaviors consistent with American Academy of Pediatrics guidelines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity, Parenting, Mobile Phone Use

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a prospective control group design
    Masking
    Outcomes Assessor
    Masking Description
    A research assistant not working on any other aspect of the study, and therefore having no knowledge of whether participants are in the control or intervention group, will measure child and caregiver height and weight. A 2nd research assistant, who is not blinded to participants, will be responsible for making appointments with participants for height and weight measures.
    Allocation
    Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile Phone Obesity Intervention
    Arm Type
    Active Comparator
    Arm Description
    Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. Approximately 30 caregiver-child dyads will be randomized into the intervention arm. Every week for 4 weeks, caregivers will receive 4 interactive multi-media phone prompts to support the intervention's targeted topics. Each mobile phone prompt starts with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share their goal/s, perceived barriers, questions, tips and strategies that may be helpful to other participants. Each week, caregivers will also receive strategies, and individual and group feedback on changing unhealthy behaviors. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. Approximately 30 caregiver-child dyads will be randomized into the control (no intervention) arm. Every week for 4 weeks, these caregivers will receive 4 interactive multi-media phone prompts around managing common illness in young children (i.e. fever, vomiting, constipation, etc.) Each mobile phone prompt will start with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share questions and strategies that may be helpful to other participants. Each week, caregivers will also receive tips and group feedback based on group questions. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    healthy weight behaviors supported by web-based mobile phone application
    Intervention Description
    Chorus is a mobile phone platform that provides texting, a web application, and an online community for mHealth interventions.Content is created using existing templates to insert text, images, pictures, audio, video clips, or any combination of these. Users interface with Chorus by clicking a hyperlink embedded in a text message sent to their phone to then access web-based interactions via prompts and clicks. Content is available in English and Spanish.
    Primary Outcome Measure Information:
    Title
    Child BMI (BMI=kg/m2)
    Description
    Child BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer
    Time Frame
    6-months post intervention
    Secondary Outcome Measure Information:
    Title
    caregiver BMI (BMI=kg/m2)
    Description
    Caregiver BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer
    Time Frame
    6-months post-intervention
    Title
    Children's Dietary Behaviors
    Description
    Children's Dietary Questionnaire (29-item instrument) measures a child's average consumption of 4 categories of foods or beverages. The 4 categories are further divided into 4 separate scores: a fruits and vegetables score, a fat from dairy products score, a sweetened beverage score, and a noncore food. Items are measured by participants responding to frequency/counts or using a likert scale. There are cutoffs provided for each score of the 4 categories. Overall, the higher the score in the fruits and vegetable sections the healthier the dietary behavior and the higher the score on dairy from fat and noncore foods the unhealthier the diet. score
    Time Frame
    6-months post intervention
    Title
    Child media-viewing behaviors
    Description
    Home Environment Inventory Survey: measures hours of watching TV, DVDs or Computer using two questions with responses including hours spent from three time categories throughout the day. The higher the number of hours reported the unhealthier the media-viewing behavior.
    Time Frame
    6-months post intervention
    Title
    Child physical activity behaviors
    Description
    Outdoor Playtime Checklist : the items on the scale ask two questions with responses from five time interval categories that are coded 0 through 4. The ordered categorical responses and summing the responses across both questions gives a maximum score of 24. The higher the score the more time spent playing outdoors.
    Time Frame
    6-months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adult male or female caregiver self-identifies as an individual of Latino descent has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian) lives with or cares for child/grandchild at least 20 hours/week is fluent in English or Spanish has the ability to participate in the mHealth intervention (ability determined by using a Subject Comprehension and Participation Assessment Tool) agrees to complete baseline, 1-, and 6-month post-baseline surveys and have adult and child height and weight measured. Exclusion Criteria: child has a failure to thrive diagnosis medical complications associated with their weight status such as Prader-Willi Syndrome
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alma Guerrero, MD, MPH
    Phone
    310-267-2789
    Email
    aguerrero@mednet.ucla.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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