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临床试验/NCT04802291
NCT04802291已完成不适用

HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2023年5月15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
459
试验地点
1
主要终点
Child Weight-Related behaviors

研究概览

简要总结

Parents are children's primary role models, are food and physical activity gatekeepers, and create the structure/lifestyle environment within the home. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a "culture of health" within the home. Yet, there continues to be a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6 to 11 years, commonly called the middle childhood years. The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group who will engage in a bona fide concurrent treatment different in subject matter but equal in nonspecific treatment effects. The participants will be families with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Enrollment for this study will begin mid-2021.This paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses.

详细描述

The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition. RCT Design CONSORT guidelines extension for social and psychological intervention trials will be used to generate a participant flow diagram and report RCT enrollment and retention data.113 Interested participants will begin by completing a short eligibility screener survey. Eligible participants who give informed consent will have immediate access to the baseline survey. Those who complete the baseline survey, meet survey plausibility checks (e.g., consistent answers to items measuring the same concept, meet minimal likely completion time, do not answer to all questions on a survey page the same), and complete the registration page (i.e., provide name and contact information) will be enrolled in the RCT. Enrolled participants will be systematically randomized by computer by alternating assignment to the experimental or attention control study condition. Recruitment materials and the bona fide treatment to be delivered to the attention control group are designed to blind participant assignment to study condition. Participants will receive intervention materials starting immediately after registration and at weekly intervals for 8 weeks. In week 9 of the study, participants will be invited to take the post survey to assess intervention effects Approximately 8 to 10 weeks after participants complete the post survey, they will be invited to take the follow-up survey to assess longer-term intervention effects.

Each week parents will be encouraged to spend about 15 minutes reviewing intervention materials; think about the changes like those suggested in the materials that could help their families; and implement 1 or 2 easy, quick, low-cost changes in their homes. Intervention materials (described in a subsequent section) provided each week for 8 weeks include an electronic informational guide for parents, tracker to list guide-related goals for the week and monitor progress toward them, 3 to 4 encouraging nudges delivered by SMS and email, and a guide for kids that is available electronically and is mailed to the participant homes along with a reminder magnet.

Participant progress through the RCT will be monitored by project staff by observing their visits to the website. Bilingual staff will be trained in customer service strategies and instructed to quickly address any participant queries submitted by email or phone using scripted responses to ensure equitable care across study groups. Participants will receive modest stipends that increase in value after they complete each survey.

Experimental Group Intervention The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2) were designed to be congruent with White House and IOM recommendations for home-centered obesity prevention interventions and critical elements for effective interventions (e.g., interventions are positive, culturally sensitive, supportive of parent-child interaction and child development; develop realistic, effective plans that empower families). Like HomeStyles for preschoolers, HomeStyles-2 for middle childhood intervention materials provide intensive, interactive, fun, non-judgmental opportunities for parents to shape their home environments and lifestyle practices to protect child health. They also promote positive strategies and changes that adults can control in their environments to reduce risk of excessive weight gain in their middle childhood youth. A positive approach teaches individuals what they can do (eat more fruits) rather than giving prohibitions (cut out fries). Substantial evidence supports parent preference for positive messages and the value of promoting positive vs restrictive behaviors to achieve health goals.

Intervention Content. Key factors contributing to childhood obesity that can be suitably addressed in the home environment with middle childhood kids identified for inclusion in the intervention materials were selected using systematic literature reviews and input from experts in childhood obesity prevention. The most salient factors affecting school-age children's health and nutritional status that emerged were inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, irregular breakfast consumption, limited physical activity, and inadequate sleep. An additional factor was children's limited food preparation skills. Attitudes toward engaging in healthy behaviors (i.e., eating fruits and vegetables, having family meals, curtailing intake of sweet beverages, controlling portion sizes, eating breakfast, getting physical exercise and limiting screentime, getting sufficient sleep, and giving children food preparation opportunities), barriers to performing healthy behaviors, strategies for overcoming barriers to healthy behaviors, and confidence in the ability to perform healthy behaviors regularly, as well as determinants of quality of life, were explored via focus groups with parents of middle-childhood youth and children ages 6 to 11 years.

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 (Participant)

盲法说明

concurrent treatments different in subject matter but equal in nonspecific treatment effects

入排标准

年龄范围
24 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • parent between the ages of 24 and 50 years with at least 1 child aged 6 to 11 years; primary food gatekeeper in the household (i.e., makes all or most decisions related to family food choices), have regular Internet access, read English and/or Spanish, and reside in the United States

排除标准

  • Does not fit inclusion criteria

研究组 & 干预措施

Healthy HomeStyles

Experimental

Online educational intervention addressing salient factors affecting school-age children's health and nutritional status: inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, irregular breakfast consumption, limited physical activity, and inadequate sleep as well as children's limited food preparation skills.

干预措施: HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood (Behavioral)

Safe HomeStyles

Active Comparator

Online educational intervention addressing aspects of home safety issues, such as indoor air quality, mold & moisture, hazardous household products, carbon monoxide, home safety, foodborne illness, and refrigerator temperatures.

干预措施: HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood (Behavioral)

结局指标

主要结局

Child Weight-Related behaviors

时间窗: Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

Child dietary intake, physical activity, and sleep behaviors

次要结局

  • Parent Weight-Related Cognitions(Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention))
  • Supports for Obesity-Preventive Measures(Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention))
  • Parent Weight-Related behaviors(Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention))

研究者

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

Carol Byrd-Bredbenner, PhD, RD, FAND

Distinguished Professor of Nutrition

Rutgers, The State University of New Jersey

研究点 (1)

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