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临床试验/NCT03433456
NCT03433456已完成不适用

Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2019年12月2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
296
试验地点
2
主要终点
Weight of Mothers

研究概览

简要总结

The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.

详细描述

Participants will be 140 mothers (>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive ~15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors.

Mothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.

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
Single (Outcomes Assessor)

入排标准

年龄范围
0 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • *Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.
  • Mothers or Primary Caregivers:
  • Age 18-75 years of age
  • Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama.
  • Mother or primary caregiver of 0-4 year old child
  • Generally Healthy
  • 0-4 years of age at time of enrollment
  • Parent or primary caregiver enrolled in First Teacher

排除标准

  • Mothers or primary caregivers:
  • Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.
  • Child has a history of a feeding or eating disorder

结局指标

主要结局

Weight of Mothers

时间窗: Baseline, 6 months, 12 months

Body weight (kg) at baseline and follow-up assessments.

Weight of Children

时间窗: Baseline, 6 months, 12 months

Body weight (kg) at baseline and follow-up assessments..

次要结局

  • Habit Strength of Targeted Behaviors(Baseline, 6 months, 12 months)
  • Household Environment Assessing the Number of Different Food Items Available(Baseline, 6 months, 12 months)
  • Household Environment Assessing the Number of Different Activity-promoting Items Available(Baseline, 6 months, 12 months)

研究者

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

Gareth R. Dutton PhD

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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