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临床试验/NCT02024360
NCT02024360已完成不适用

Center for Research in Implementation Science and Prevention (CRISP) - Community Outreach - Obesity Prevention Trial (CO-OPT)

Denver Health and Hospital Authority2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年3月1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
300
试验地点
2
主要终点
Change in BMI z-score

研究概览

简要总结

The purpose of this research is to investigate the effectiveness of a community health worker-based program as an adjunct to clinical services regarding childhood obesity management. This family-centered program will be delivered in the community and homes of enrolled families. The primary outcome will compare change in age-gender specific body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped wedge engagements. The intervention lasts for 6 months and the time prior to engagement in the intervention will serve as the control period. Intervention construct validity will be evaluated using data on diet, activity, and fitness. The primary goal is to examine the effect of the intervention in reducing the zBMI in the index patient and secondarily on any participating family members. We will test effectiveness among demographic groups under-represented in prior studies, including very young children and Latinos. Results from this study will inform future intervention modifications and permit effect size estimation and power calculations for future randomized trials that include a community health worker-based obesity prevention and treatment program. During the course of the study, an obesity registry will be designed and implemented within an integrated safety-net healthcare system to measure primary obesity outcomes in a low-income population and conduct analyses. The community health worker will be using several new technologies (e.g., text messaging and patient relationship manager [PRM]) as an adjunct when working with an obese child and his/her family. Targeted training for clients, providers and CHW will be part of the prevention strategies implemented during the grant period, these will include motivational interviewing. All of these (i.e., obesity registry, technologies and training) will have an evaluative component.

详细描述

Primary Aim:

Design, conduct and evaluate a pilot community health worker (CHW) feasibility study in families with at least one overweight/obese child, targeting change in primary obesity outcomes (i.e., zBMI and health behaviors using the "5-2-1-0" targets).

  1. To determine the effect of a community health worker mediated childhood obesity prevention program with families on BMI in overweight and obese (O/O) children aged 2-6 years The study sample size is selected for power to evaluate specific aim 1.a.

  2. Hypothesis: Compared to children receiving delayed-intervention, a higher proportion of O/O children in the intervention group will experience a >0.1 zBMI decrease in zBMI by -age/gender over the same 12 month period.

  3. Hypothesis: Within individual subjects, compared to their own zBMI measurements 12-24 months prior, O/O children on average will experience a decrease in the slope of their BMI trajectory of >0.1 zBMI per year after starting the intervention.

  4. To determine the effect of the intervention on physical activity and eating behaviors of the index patient and their family members as summarized in "5-2-1-0" daily targets (i.e., 5 fruits and vegetables, less than 2 hours screen time, 1 hour of exercise and 0 sweetened drinks).

a. Hypothesis: Compared to baseline measures in children receiving delayed-intervention, a higher proportion of O/O children in the intervention group will experience an improvement in "5-2-1-0" measures over the same 12 month period. 3. To determine the effect of the intervention in change in parenting skills and to evaluate the effects of the intervention on weight-related quality of life measures in the parents of O/O children 2-6 years.

研究设计

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

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 2-6 years old with a BMI above the 85 %ile

排除标准

  • non-English and non-Spanish speaking, any chronic conditions

结局指标

主要结局

Change in BMI z-score

时间窗: Baseline, post intervention, 6 months post intervention

BMI z-score will be calculated for each child at the indicated times

次要结局

未报告次要终点

研究者

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

Arthur Davidson

Director, Public Health Informatics and Epidemiiology

Denver Health and Hospital Authority

研究点 (2)

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