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OpenTrials
Completed

NCT Number: NCT04261985

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

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

healthy weight behaviors supported by web-based mobile phone application

Behavioral

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 was created in English and Spanish.

Primary outcomes

  1. Child Weight

    Time frame: 6-months post baseline

    Child pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds

Secondary outcomes

  1. Caregiver Weight in Pounds

    Time frame: 6-months post-intervention

    Caregiver pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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