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临床试验/NCT04164277
NCT04164277已完成不适用

Using Facebook and Participatory Learning in an Intergenerational Intervention to Prevent Obesity in Head Start Preschoolers

Michigan State University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1

研究概览

简要总结

This project will determine the preliminary efficacy of an innovative intergenerational intervention among Head Start preschoolers, aged 3-5 years, and their caregivers. A two-group cluster randomized controlled trial will be conducted. Six Head Start centers will be randomly assigned to the intervention (n=3) or control group (n=3), and an average of 6 caregiver-preschooler dyads will be recruited from each class (N=144 dyads from 16 classes). Grounded in an Actor-Partner Interdependence Model, the 16-week intervention has 3 components: 1) a caregiver component, including 1a) a Facebook-based program with weekly electronic retrievable flyers providing health information and behavioral change strategies and 4 weekly habit-formation tasks to improve parenting practices and home environment for preschoolers; and 1b) 3 face-to-face or virtual meetings (weeks 1, 8, & 16) to establish personal connections and communication networks among caregivers, discuss strategies, and share community resources to support preschoolers' behavioral changes at home; 2) a caregiver-preschooler learning component via Facebook messenger to send preschooler letters to each caregiver privately by the research team twice per week to 2a) share the preschooler's experiences of learning at school and his/her interests for a healthy diet and physical activity at home, and 2b) elicit caregivers' response to the letters; and 3) a Head Start center-based preschooler component to help preschoolers establish healthy habits via weekly healthy diet and physical activity participatory learning.

详细描述

The purpose of this two-group cluster randomized controlled trial is to determine the preliminary efficacy of an innovative intergenerational intervention on improving preschoolers' moderate-to-vigorous physical activity and diet quality, and decreasing screen time, proportion of overweight and obesity, and body mass index z-score among Head Start preschoolers (aged 3-5 years) and their caregivers.

The intervention is guided by an Actor-Partner Interdependence Model, and will target both individual-level factors, including knowledge, self-efficacy, and skill, and socio-environmental factors, including parental support for child, parenting practices, and the home environment. The 16-week intervention has three components: 1) a caregiver component including 1a) a Facebook-based program with weekly electronic retrievable flyers providing health information and behavioral change strategies, and four weekly habit-formation tasks to create a healthier home environment for preschoolers; and 1b) three face-to-face or virtual meetings (weeks 1, 8, & 16) to establish personal connections and communication networks among caregivers and discuss strategies and share community resources to support behavioral changes at home; 2) a caregiver-preschooler learning component via Facebook messenger to send preschooler letters to each caregiver privately by the research team twice per week to share the preschooler's experiences of learning at school and his/her stated interests for healthy diet and physical activity at home, and to ask caregivers to respond to the letters; and 3) a Head Start center-based preschooler component to help preschoolers establish healthy habits via weekly healthy diet and PA participatory learning.

From the eligible 13 Head Start centers with at least three classrooms in one Head Start organization, six Head Start centers will be randomly selected and assigned to the intervention (n = 3) or control (n = 3) group with usual Head Start activities. Three to five classes will be randomly selected from each selected Head Start center to be involved in the study. In each class, six caregiver-preschooler dyads will be randomly selected from the eligible participants, and total 24 caregiver-preschooler dyads will be recruited from each center, yielding a total of 144 dyads.

Three specific AIMS are:

AIM 1: Determine the preliminary efficacy of FirstStep2Health vs control among preschoolers on improving proximal behavioral changes of moderate to vigorous physical activity measured by accelerometry (primary outcome); diet quality (e.g., fruits/vegetables, fiber, whole grains, total protein, dairy, sugar-sweetened beverages, total sugars/fats), and screen time (e.g., watching television, playing video games); and decreasing distal anthropometric outcomes of proportion of overweight or obese and body mass index z-score. The investigators expect an overall decrease in body mass index z-score in intervention preschoolers because overweight or obese preschoolers' body mass index z-score is expected to decrease while healthy-weight preschoolers will have no change. The investigators focus on proximal behavioral changes as our primary outcome instead of distal anthropometric outcomes due to the brevity of this study and the need for behavioral changes to be maintained for at least a year before manifesting in changes in anthropometric outcomes.

研究设计

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

盲法说明

Data collectors and interviewers will be blinded to the randomization.

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •. There are ten inclusion criteria (five for preschoolers and five for caregivers).
  • •Preschoolers must:
  • •Have parental consent.
  • •Have child assent if the child is 5 years old.
  • •Be 3-5 years of age. The investigators prioritize this age group because intervening with preschoolers before age 5 results in better short- and long-term weight reduction outcomes than with children older than 5; and children who are at least 3 years-old have the motor and cognitive development to participate in a healthy eating and physical activity curriculum.
  • •Be able to understand and speak English. The intervention will be delivered in English.
  • •Be enrolled in the full-day or part-day Head Start program. Head Start offers part-day and full-day programs. To increase the generalizability of the study findings, preschoolers from both full-day and part-day programs will be recruited in this study.
  • •Caregivers must:
  • •Provide consent.
  • •Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis.
  • •Be able to read, understand, and speak English. The intervention will be delivered in English.
  • •Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study Facebook site for participating in the Facebook-based program.
  • •Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study.

排除标准

  • •. There are three exclusion criteria for both caregivers and preschoolers.
  • •Preschoolers or caregivers who have medical conditions precluding participating in dietary changes or physical activity.
  • •Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants).
  • •Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

研究组 & 干预措施

Intervention

Experimental

The 16-week intervention includes three components:

  1. Caregiver Component. Facebook-based program including four new habit-formation tasks/week, and 3 face-to-face or virtual caregiver meetings: MSU research staff will lead the meetings at Head Start centers (weeks 1, 8, & 16) to connect caregivers to each other, offer health information, and discuss behavioral change strategies.
  2. Caregiver-Preschooler Learning. Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent privately to each caregiver , and caregivers will be asked to respond to the letters.
  3. Center-based Preschooler Component. Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators.

干预措施: Caregiver Component. (Behavioral)

Intervention

Experimental

The 16-week intervention includes three components:

  1. Caregiver Component. Facebook-based program including four new habit-formation tasks/week, and 3 face-to-face or virtual caregiver meetings: MSU research staff will lead the meetings at Head Start centers (weeks 1, 8, & 16) to connect caregivers to each other, offer health information, and discuss behavioral change strategies.
  2. Caregiver-Preschooler Learning. Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent privately to each caregiver , and caregivers will be asked to respond to the letters.
  3. Center-based Preschooler Component. Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators.

干预措施: Caregiver-Preschooler Learning. (Behavioral)

Intervention

Experimental

The 16-week intervention includes three components:

  1. Caregiver Component. Facebook-based program including four new habit-formation tasks/week, and 3 face-to-face or virtual caregiver meetings: MSU research staff will lead the meetings at Head Start centers (weeks 1, 8, & 16) to connect caregivers to each other, offer health information, and discuss behavioral change strategies.
  2. Caregiver-Preschooler Learning. Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent privately to each caregiver , and caregivers will be asked to respond to the letters.
  3. Center-based Preschooler Component. Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators.

干预措施: Center-based Preschooler Component. (Behavioral)

Control

No Intervention

Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes.

结局指标

主要结局

Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1

时间窗: Moderate-to-vigorous physical activity at 17 weeks

The ActiGraph GT3X accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Each caregiver-preschooler dyad will receive the accelerometers at the same time and data collectors will explain to both caregiver and preschooler how to wear the accelerometers. Preschoolers' caregivers will be instructed to return monitors either at the Head Start center or via mail using using the provided prepaid envelope after the seventh day. Data will be downloaded to the same computer used to initialize monitors. Initial analysis will use 15-sec. epochs and the following count thresholds: moderate (420-841 counts/15 seconds) and vigorous PA (≥ 842 counts/15 seconds). Fifteen-second increments with counts ≥ 420 will be summed to determine minutes of MVPA.

次要结局

  • Fruit/Vegetable Intake (Preschoolers)-AIM 1(Fruit/vegetable intake at 17 weeks)
  • Screen Time (Preschoolers)-AIM 1(Screen time at 17 weeks)
  • Number of Preschoolers Who Are Overweight or Obese-AIM 1(Proportion of overweight and obesity at 17 weeks)

研究者

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

Jiying Ling

Associate Professor

Michigan State University

研究点 (1)

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