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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Unknown status
CT.gov ID
NCT04261985
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
132
2
11.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: healthy weight behaviors supported by web-based mobile phone application
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a prospective control group designa prospective control group design
Masking:
Single (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.
Primary Purpose:
Health Services Research
Official Title:
A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mobile Phone Obesity Intervention

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
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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Child BMI (BMI=kg/m2) [6-months post intervention]

    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

  1. caregiver BMI (BMI=kg/m2) [6-months post-intervention]

    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

  2. Children's Dietary Behaviors [6-months post intervention]

    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

  3. Child media-viewing behaviors [6-months post intervention]

    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.

  4. Child physical activity behaviors [6-months post intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Los Angeles
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alma Guerrero, MD, MPH, Associate Clinical Professor of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04261985
Other Study ID Numbers:
  • 1R21HD096298-01A1
  • 1R21HD096298-01A1
First Posted:
Feb 10, 2020
Last Update Posted:
Feb 12, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2020