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

Not Applicable

Completed

• Conditions: Mobile Phone Use; Childhood Obesity; Parenting
• Interventions: Behavioral: healthy weight behaviors supported by web-based mobile phone application

• Registration Number: NCT04261985
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-10
• Study Start: 2020-06-08
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Results First Submitted: 2022-02-26
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Phone Obesity Intervention	healthy weight behaviors supported by web-based mobile phone application	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.

Primary Outcome Measures

Name	Time	Method
Child Weight	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 Outcome Measures

Name	Time	Method
Caregiver Weight in Pounds	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

Trial Locations

Locations (1)

UCLA David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States