跳至主要内容
临床试验/NCT05032430
NCT05032430进行中(未招募)不适用

Reducing Maternal Stress to Improve Obesity-related Parenting Practices

American University2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
115
试验地点
2
主要终点
Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire

研究概览

简要总结

Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. A mindful parenting program might reduce Latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. The primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in Latina mothers. The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina mothers of elementary-school age children. Participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. Feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. Completion of this project will inform the development of a full-scale efficacy trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • over the age of 18 years
  • identify as female
  • identify as Hispanic or Latina
  • have a child between the ages of 3 and 11 years who primarily resides with them
  • able to understand basic instructions in either Spanish or English

排除标准

  • pregnant or planning on becoming pregnant in the near future
  • actively dependent on a substance
  • have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting
  • child has an obesity-associated genetic syndrome
  • child has a pervasive developmental disorder

结局指标

主要结局

Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire

时间窗: Immediately after the intervention

Parents will be asked to complete a brief, 8-item, widely used measure of satisfaction with health-related services, available in Spanish and English. Scores range from 8 to 32, with higher values indicating higher satisfaction.

Participant Retention

时间窗: At the beginning of each of the 6 weekly intervention sessions

Research staff will take attendance during each intervention session.

次要结局

  • Change in the Child Feeding Questionnaire(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)
  • Change in height in meters(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)
  • Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)
  • Change in the Perceived Stress Scale(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)
  • Change in weight in kilograms(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)
  • Change in the Five Facet Mindfulness Questionnaire(Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline)

研究者

发起方
American University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Cotter

Assistant Professor

American University

研究点 (2)

Loading locations...

相似试验

Reducing Maternal Stress to Improve Obesity-related... | 临床试验