Back to resultsA 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
About this trial
This is an interventional health services research trial for Childhood Obesity
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
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
NCT ID
NCT04261985
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)
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
A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
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