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临床试验/NCT01565161
NCT01565161已完成不适用

Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention

Harvard Pilgrim Health Care4 个研究点 分布在 2 个国家目标入组 117 人开始时间: 2011年6月最近更新:
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
117
试验地点
4
主要终点
Parent and child health behaviors

研究概览

简要总结

While childhood obesity rates may have plateaued in some US population subgroups, such as whites and those of higher socioeconomic status, overall rates of obesity remain high and racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising approaches for childhood obesity prevention and management are interventions that begin early in life and that support change at the individual and community levels.

The goal of this project is to develop and test an intervention delivered to racial/ethnic minority and low income parents of 2-5 year old children in their homes, designed to promote adoption of household routines and parenting strategies that are preventive of obesity. To achieve this goal, the investigators will work with community health centers in Boston, Cambridge, and Somerville to recruit families to participate in an individual-level randomized controlled trial. The investigators partner community health centers include the Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the Cambridge Health Alliance (CHA).

Participants will be randomized to receive either 1) mailed educational materials for the duration of the 6-month program (control), or 2) home-based health coaching visits and phone calls with a health educator, text messages, and educational materials promoting the adoption of household routines and target behaviors (intervention).

The investigators goal is to evaluate the feasibility and effectiveness of the investigators designed intervention (as compared to the control condition) using baseline and post-intervention data. In order to do so, the investigators will assess change from baseline to post-intervention in the investigators key behavioral outcomes of interest, including adoption of three household routines:

  1. Regularly eating meals together as a family
  2. Obtaining adequate sleep
  3. Limiting screen-viewing time

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
None

入排标准

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

入选标准

  • Parent with child between 2-5 years old
  • Child has a TV in the room where s/he sleeps
  • Parent is comfortable reading, writing and having conversations in English or Spanish
  • Child was seen for a well-child care visit at one of collaborating community health centers in the last 90 days

排除标准

  • Parent is not 18 years or older
  • Family is planning to move from the Boston area in the net 6 months
  • Child has a physical/mental health condition which requires chronic care

研究组 & 干预措施

Home-Based Health Coaching

Experimental

Intervention delivered in the home.

干预措施: Home-Based Health Coaching (Behavioral)

Control Arm

Active Comparator

Mailed educational materials

干预措施: Mailed materials (Behavioral)

结局指标

主要结局

Parent and child health behaviors

时间窗: Baseline, 6 months

Using parent self-report surveys, we will assess change from baseline to post-intervention in parent and child behaviors related to the following health outcomes: * TV viewing, including TV in the room where the child sleeps, time spent watching TV, total screen time * Sleep, including parent and child sleep duration and presence of a calming nighttime routine * Diet, including eating meals together as a family, lowering intake of fast food, and lowering intake of sugar-sweetened beverages

TV Viewing Time

时间窗: Baseline, 6 months

Using two separate measures of Child TV viewing time (parent-report and measured TV time using the TV Allowance device, we will assess change from baseline to post-intervention in the amount of TV the child watches. Additionally, using parent-report surveys we will assess change from baseline to post-intervention in total screen time as well as observed presence of TV in the room where the child sleeps.

次要结局

  • Child height and weight measurements(Baseline, 6 months)
  • Cognitive stimulation in the home(Baseline, 6 months)
  • Presence of media devices in the home(Baseline, 6 months)
  • Use of mobile technology(Baseline)

研究者

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

Elsie Taveras

Associate Professor

Harvard Pilgrim Health Care

研究点 (4)

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