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临床试验/NCT04261985
NCT04261985已完成不适用

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

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Child Weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Child Weight

时间窗: 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

次要结局

  • Caregiver Weight in Pounds(6-months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alma Guerrero, MD, MPH

Associate Clinical Professor of Pediatrics

University of California, Los Angeles

研究点 (2)

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