跳至主要内容
临床试验/NCT01538615
NCT01538615已完成不适用

Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

University of Minnesota2 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2010年7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
413
试验地点
2
主要终点
Change in Child Body Mass Index (BMI Z-score)

研究概览

简要总结

The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In additions, the project will also examine how the HOME Plus family intervention influences children's dietary intake, frequency of family meals, availability of healthy and unhealthy foods in the home and served at meals and snacks, and screen time (TV, game systems). The study will provide important information on strategies that families can use at home to prevent obesity.

详细描述

Childhood obesity is a serious public health problem with limited effective prevention strategies to date. Although previous nutrition and physical activity environmental approaches for obesity prevention show some promise, most studies have not shown reductions in excess weight gain. Moreover, few prevention studies significantly engage parents and focus on the home environment. To prevent childhood obesity it is essential to promote healthy behaviors in the home environment because parents are influential primary role models for healthy eating and sedentary behavior, and are gatekeepers for food and beverage availability and degree of inactivity within the home. Moreover, the home setting is where most of children's calories and energy dense foods are consumed and where children engage in much of their sedentary behavior, particularly screen time (e.g., television, computer, game system). The proposed study will test the efficacy of the Healthy Home Offerings via the Mealtime Environment (HOME) Plus program, a ten-month, family-based health promotion intervention to prevent excess weight gain among 8-12 year old children. The program is based on Social Cognitive Theory and a socio-ecological framework and promotes both regular and nutritionally-sound snacks and meals in which family members eat together (i.e., family meals) and encourages reductions in sedentary behavior, particularly screen time among children in the home setting. The efficacy of the intervention will be tested in a randomized controlled trial with 160 families randomized to two conditions (intervention or attention-only control). Two cohorts of families, recruited from after-school programs and community centers, will be followed for 2.5 years. The primary hypothesis is that, by the end of the ten month intervention, target children in the intervention families, relative to children in the control families, will have significantly lower body mass index (BMI; primary outcome) after adjustment for baseline BMI values. Secondary outcomes include frequency of weekly family meals and number of healthful foods and beverages available in the home and served at family meals and snacks (as reported by parent), target children's daily intakes of healthful foods and beverages, and target children's minutes of sedentary behavior per week, particularly screen time. Child and parent measurement will occur in their homes at baseline, post-intervention (12-months post-randomization), and follow-up (9-months post-intervention) by trained research staff. The proposed study builds upon successful methods from our HOME pilot study (2006-2008; NIH R21-DK0072997) and is innovative as it actively engages entire families in experiential activities and capitalizes on the home setting. The study will provide important information on environmental and behavioral strategies that families can use at home to prevent excess weight gain. The intervention program has high translation potential and is likely to be immediately useful to families of school-age children because it will be tested in real-world community settings and sustained across the state of Minnesota by the University of Minnesota's Extension Service.

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

盲法说明

This is a behavioral intervention. Masking is not feasible.

入排标准

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

入选标准

  • the target child is between the ages of 8-12 years
  • the target adult parent or guardian is the primary food preparer in the home
  • target child has an age and gender adjusted body mass index at or above the 50th percentile
  • participants are willing to be randomized into one of two groups (intervention or control)
  • target child must live with participating adult most of the time

排除标准

  • participants plan to move out of the area in the next six months
  • participants have a severe food allergy, limitation, or medical condition that prevents them from participating in the intervention
  • participants do not speak and read in English

研究组 & 干预措施

HOME Plus Intervention

Experimental

described below

干预措施: HOME Plus intervention (Behavioral)

Control

No Intervention

Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.

结局指标

主要结局

Change in Child Body Mass Index (BMI Z-score)

时间窗: Change from Baseline at 12 and 21 months

Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.

次要结局

  • Change in Target Children's Daily Intakes of Fruits and Vegetables(Change from Baseline at 12 and 21 months)
  • Change in Number of Fruits and Vegetables Available in the Home(Change from Baseline at 12 and 21 months)
  • Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week(Change from Baseline at 12 and 21 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验