Clinical trial NCT04261985: A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
Official title: A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Parenting
Mobile Phone Use
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-10
Enrollment: 59
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective control group design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Weight
timeFrame: 6-months post baseline
Secondary outcomes:
measure: Caregiver Weight in Pounds
timeFrame: 6-months post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
Study officials:
References: