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临床试验/NCT05612971
NCT05612971进行中(未招募)不适用

iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Rural Families

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2023年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
480
试验地点
1
主要终点
Percent weight change in parents and BMIz (BMI z-score) in children

研究概览

简要总结

The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.

详细描述

The goal of this project is to determine if an adult intervention followed by a family-based program (iAmHealthy Parents First) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iAmHealthy). Furthermore, the investigators aim to discover if administering iAmHealthy Parents First will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iAmHealthy. Parent/child dyads will be recruited from rural elementary schools, medical clinics, and organizations across Kansas and neighboring states.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Family lives in a rural area (city and/or county population <20,000) or as defined by RUCA codes, Urban Influence Codes, amount of agricultural income, or individual commuting patterns
  • •Child BMI%ile ≥ 85th and parent BMI 25-50 kg/m2
  • •Child in 1st-5th grade or 6-11 years of age
  • •Child and parent speak English
  • •Family is available at times intervention is offered

排除标准

  • •For parents: new MI, stroke or cancer diagnosis in past 6 months, recent bariatrics surgery (within 2 years) or planned within 1 year, pregnancy in last 6 months or planned within 1 year

研究组 & 干预措施

iAmHealthy Parents First

Experimental

iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. Fifteen dyads from each cohort will be randomized to the iAmHealthy Parents First group.

After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. iAmHealthy Parents First adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program.

干预措施: iAmHealthy Parents First (Behavioral)

iAmHealthy

Active Comparator

iAmHealthy families will receive an informational newsletter once a month for three months. This group will be given the flexibility to start their weight loss journey using self-guided methods. No formal group sessions will be provided for three months. Fifteen dyads from each cohort will be randomized to the iAmHealthy group.

After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program.

干预措施: iAmHealthy (Behavioral)

结局指标

主要结局

Percent weight change in parents and BMIz (BMI z-score) in children

时间窗: Baseline, 3 months, 9 months

Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team.

次要结局

  • Mediator: Attendance(Baseline, 3 months, 9 months)
  • Mediator: Reciprocal modeling(Baseline, 3 months, 9 months)
  • Moderator: Family functioning(Baseline, 3 months, 9 months)
  • Moderators: Genetic casual attributions(Baseline, 3 months, 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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