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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Childhood Obesity, Parenting, Mobile Phone Use

Intervention / Treatment
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* Behavioral: healthy weight behaviors supported by web-based mobile phone application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a prospective control group design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mobile Phone Obesity Intervention<br>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. | Behavioral: healthy weight behaviors supported by web-based mobile phone application<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6-months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6-months post-intervention | 
| 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 | 6-months post intervention | 
| 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. | 6-months post intervention | 
| 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. | 6-months post intervention |