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

Not Applicable

Completed

• Conditions: Mobile Phone Use; Childhood Obesity; Parenting

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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