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临床试验/NCT03590301
NCT03590301已完成不适用

Third Ward Wellness Study for Families

University of Houston1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年8月8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
27
试验地点
1
主要终点
Comprehensive General Parenting Questionnaire

研究概览

简要总结

The Third Ward Wellness Study aims to pilot test a wellness program for families with toddler age children. Participants will be recruited from the Third Ward neighborhood in Houston, TX and then randomly assigned to one of two wellness programs. The goal of both programs is to enable and inspire parents to help their toddler age children develop healthy habits that will stay with them through life. Participating families will complete an assessment batter before and after the program. Both programs will meet once per week for 10 weeks.

详细描述

Dietary and activity habits begin to develop in early childhood. Parents have the most influence on children's health behaviors at this age. Many parents, particularly those from lower income and underserved areas may benefit from programs to inspire and enable them to raise their toddler age children with good health habits. The experimental group was developed to help parents instill healthy habits in their children through a healthy home environment. This study will pilot test the experimental group among parent-toddler dyads residing in Greater Third Ward neighborhoods, where > 80% of the residents are AA or Hispanic and 35%-54% have annual household incomes <$25,000. The aims are to ascertain 1) recruitment and retention barriers and facilitators, 2) treatment success barriers and facilitators, and 3) the estimated effect sizes of outcomes to inform a fully powered RCT. The exploratory hypotheses are that compared to those in the control group, parents in the experimental group will have greater increases in positive parenting skills (Comprehensive General Parenting Questionnaire), and toddlers will have greater increases in indicators of a healthy home environments, diets and activity habits (MVPA, sedentary activity, and sleep).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will not know whether they are in the control or experimental group.

入排标准

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

入选标准

  • •Parents need to be...
  • •The legal custodian of a toddler,
  • •At least 18 years,
  • •Able to make food decisions in the home,
  • •Have access to a phone at home,
  • •Be fluent in English Toddlers need to be...
  • •Between 12 and 36 months of age
  • •Be able to walk.

排除标准

  • •Adults unable to consent for themselves and their child,
  • •Parents or toddlers who have mental or physical health conditions that would prevent them from fully engaging in activities of the program (e.g., reliance on feeding tube).

研究组 & 干预措施

FUNPALs Playgroup

Experimental

Based on Self-Determination Theory, the FUNPALs Playgroup will enable and inspire parents to encourage their children to improve their diet and activity behaviors through general authoritative parenting, structured feeding practices, and a healthy home environment. Parents and toddlers will participate in the FUNPALs Playgroup together where they will be led through a series of open but structured activities including free play, exercise, snack preparation, discussion, singing, and yoga stretches.

干预措施: FUNPALs Playgroup (Behavioral)

Healthy Toddlers Parent Group

Active Comparator

The goal of the Healthy Toddlers Parent Group is to deliver the same nutrition and activity messages to parents as those delivered in the FUNPALs Playgroup. In the Healthy Toddlers Parent Group, parents (without children) will meet in groups to receive information on nutrition and activity as it relates to their toddlers and they will engage in a discussion around how they do or can implement these behaviors. No experiential learning, children, play, or parenting instruction will be included in this control condition.

干预措施: Healthy Toddler Parent Group (Behavioral)

结局指标

主要结局

Comprehensive General Parenting Questionnaire

时间窗: Baseline and immediate post intervention

This 69-item measure of general parenting will assess changes in domains of positive parenting (i.e., authoritative parenting): nurturance, structure, and behavioral control.

次要结局

  • Toddler dietary intake(baseline and immediate post intervention)
  • Child sedentary, moderate to vigorous, and sleep activity(Baseline and immediate post intervention)
  • Structure Feeding Practices (Savage et al., 2017)(baseline and immediate post intervention)
  • Home environment(baseline and immediate post intervention)
  • Toddler fruit and vegetable intake(Baseline and immediate post intervention)

研究者

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

Tracey Ledoux

Associate Professor

University of Houston

研究点 (1)

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