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临床试验/NCT03957148
NCT03957148已完成不适用

Effectiveness of an Information-Motivation-Behavior Skills (IMB)-Based Intervention for Reducing Sugar-Sweetened Beverage (SSB) Consumption in Preschool Children

UConn Health2 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2008年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
484
试验地点
2
主要终点
Availability of sugar-sweetened beverages for the child in the home

研究概览

简要总结

Sugar-sweetened beverages and over consumption of 100% fruit juice add unneeded calories to the diets of children, potentially leading to overweight. As children's diets are extensions of their parent's behaviors, the investigators propose to implement a nutrition education intervention based on the Information-Motivation-Behavioral Skills (IMB) behavior change model using parents as the primary agent of change. This project will evaluate an intervention to reduce sugar-sweetened beverages in preschool children from low-resource families. The proposed research uses a randomized control group design involving 20 parents of 3-5-year-old children at 20 sites (n=400) over 3 years. The investigators will randomly assign sites to two experimental conditions: 1) 10-week sugar-sweetened beverage intervention and 2) 10-week sham education control. Data collection for the two groups will be conducted at baseline and 1 weeks and 6 months post intervention. Measures to be collected include and IMB survey, home beverage inventory (HBI), weekend food recall, and anthropometrics. Education programs will be available to all parents at sites through interactive display boards with 5-10-minute lessons. Each semester 8 students (n=32) will enroll in an experiential course aimed at increasing students' cultural competency. For 10 weeks, students will attend classroom training and spend 2 hours twice a week at sites implementing the nutrition education program.

详细描述

BACKGROUND. Sugar sweetened beverages (SSB), including sodas, fruit drinks, nectars, and ice teas, make up the largest source of added sugar in the American diet. Fruit juices and fruit drinks alone contribute 17-18% of the energy in children's diets. For young children, beverage consumption depends on beverages available and served at home by parents. Consequently, the most effective pathway for reducing SSBs in pre-school children must target the parent as the agent of change. The IMB model is the theoretical foundation for behavior change in this project. Unlike other behavior change models, IMB incorporates three major constructs that theoretically interact, leading to the outcome behavior. Each construct of IMB (information, motivation, and behavioral skills) includes subconstructs as a basis for tailoring the model to an individual health-related behavior.

RESEARCH DESIGN AND METHODS. The proposed design allows for 2 sets of systematic comparisons that will address the major study hypotheses: 1) analysis of the differences in outcomes between intervention and control groups at baseline, 1-week post-intervention and 6 months post-intervention; and 2) analysis of the IMB factors that mediate the impact of the intervention on the key outcome measures.

Participants in the intervention will receive 10 weeks of SSB-related nutrition education at their child's preschool or daycare. Twice a week, two student educators will be available to parents (both research participants and casual observers) at each site for 2 hours during the typical afternoon pick-up. Each week a different lesson pertaining to parental information, motivation, or behavioral skills related to SSB will be presented via an interactive display board. Lessons will last 5 to 10 minutes, as parents realistically only have this amount of time to stop at an educational board before or after picking up their child. These displays will include an activity for parents to apply knowledge and skills learned during the short lesson. Educators will also provide parents with informational handouts pertaining to each lesson to reinforce concepts learned. In addition, the program will include educational flyers and posters for site promotion. All materials to be developed will be culturally sensitive, available in English and Spanish, and appropriate for this low-literacy population.

Target Population. Twenty Hartford area center or school based early childcare centers serving primarily low-income, minority families will be recruited to participate in the study.

Sample Size. Investigators estimated a target sample size of 400 to provide enough stability in the parameter estimates and power to detect effects in the major set of analysis for the current research. Based on our previous efforts in conducting preschool based prevention research, the investigators expect follow-up retention rates to be 75%. Families who move or leave the site during the study will be retained for analysis.

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

入选标准

  • Parent-child dyads where the children attend a center-based early childcare center in Hartford, CT that is part of the City of Hartford sponsored School Readiness Network.
  • Easy access to a telephone

排除标准

  • If more than two children are eligible, the oldest child would be part of the study.
  • Children with medical issues that restrict normal eating.

结局指标

主要结局

Availability of sugar-sweetened beverages for the child in the home

时间窗: Baseline compared to one month, three months and six month post initiation of intervention.

Inventory of all beverages in the home exclusive of alcohol .

Child consumption of sugar-sweetened beverages.

时间窗: Baseline compared to one month, three months and six month post initiation of intervention.

Parent records of food intake for two weekend days of their children cross checked with an Inventory of all beverages in the home, exclusive of alcohol.

次要结局

未报告次要终点

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Ferris

Professor emerita Medicine and Public Health

UConn Health

研究点 (2)

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