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临床试验/NCT04414553
NCT04414553已完成不适用

Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children

University of Colorado, Denver4 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年3月13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
78
试验地点
4
主要终点
%BMIp95

研究概览

简要总结

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using pre/post design will be conducted.

The hypothesis is that children participating in Community-AHF will demonstrate a reduction in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with pre-intervention

详细描述

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a pre/post design will be conducted.

As this is a pilot study, the study will not be powered to detect statistically significant differences pre- and post- intervention. The investigators will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. Without a counterfactual (control group) the investigators will not be able assign responsibility to Community-AHF for any observed improvements. Change in %BMIp95 across the study period will provide data to test our hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and post-intervention data is ideal for generating sample size estimates for a larger randomized control trial in the same population.

The investigators will conduct within-individual analyses for each outcome of interest. The investigators will only analyze participants who contribute pre and post measures in order to avoid biases that can occur when analyses are conducted with all available data. For each outcome for which a participant contributes pre and post measurements, the investigators will calculate pre and post means, standard deviations, differences in means and the p-value of the difference. The investigators will conduct preliminary analyses of outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, the investigators will explore the possibility of a nonresponse analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Child age 5-12 years with Parent/Caregiver age of 18 or more years
  • Child BMI >/= 85th percentile for age
  • Parent is foreign-born, self identifies as Latino/Hispanic and speaks Spanish
  • Parental commitment to participate in a 4-month intervention

排除标准

  • Child health condition that prevents diet modification or engaging in physical activity
  • Child BMI >40kg/m2

结局指标

主要结局

%BMIp95

时间窗: 4 months

Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.

BMI Category

时间窗: 4 months

This measure examines BMI category of overweight, obesity, severe obesity pre/post program

次要结局

  • Child Physical Activity(4months)
  • Parenting Self-Efficacy(4 months)
  • Parent Perceived Stress(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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