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临床试验/NCT06548074
NCT06548074已完成不适用

Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement (H-PACE) Program

Fred Hutchinson Cancer Center2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年1月22日最近更新:
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
122
试验地点
2
主要终点
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)

研究概览

简要总结

This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.

详细描述

OUTLINE:

Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component introduces children to tasty and healthy foods and teaches children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.

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

入选标准

  • •Children in 3rd - 5th grade, 8-11 years of age, attending the afterschool program at the selected elementary schools.
  • •Parents/Guardians of the eligible child, who are ≥ 18 years old.
  • •Fluency in English or Spanish.

排除标准

  • •Children who are not in 3rd - 5th grade.
  • •Children not attending the afterschool program at the selected elementary schools.
  • •Parents/Guardians of the eligible child, who are < 18 years old.

研究组 & 干预措施

Prevention (H-PACE program)

Experimental

See Detailed Description.

干预措施: Accelerometer (Other)

Prevention (H-PACE program)

Experimental

See Detailed Description.

干预措施: Questionnaire Administration (Other)

Prevention (H-PACE program)

Experimental

See Detailed Description.

干预措施: Supportive Care (Other)

Prevention (H-PACE program)

Experimental

See Detailed Description.

干预措施: H-PACE Behavioral Intervention (Behavioral)

结局指标

主要结局

Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)

时间窗: Up to week 14

Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.

Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)

时间窗: Up to week 14

Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.

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

Jason Mendoza, MD, MPH

Professor

Fred Hutchinson Cancer Center

研究点 (2)

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