DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in home environment design for wellness, as assessed by DWELL questionnaire
研究概览
简要总结
Design for wellness (DWELL) is an online Facebook intervention developed to effectively cause participants to design their home environments for wellness. Also, to improve health behaviors (specifically: healthy nutrition, physical activity, smoke free home and hygiene); to improve awareness of the importance of the environment in healthy behaviors; and to improve overall wellness. The research will follow qualitative methods in early stages for a deep understanding of participants' needs and inputs, complimented by a rigorous, quantitative approach using randomized controlled trail (RCT) for program evaluation. Participants are Israeli mothers to children up to 18 years old with Facebook profile, who are often in Israel responsible for household management and raising the family. The program will provide the participants with an accessible and convenient online setting for active and group oriented collaborative learning, in informal personalized environment. Motivating the participants to enhance their engagement in DWELL online community is expected to encourage the participants to design their home environment for wellness and improve their health behaviors and overall wellness.
详细描述
The primary aim of the study is to assess the effectiveness of the intervention on home design for wellness (DWELL). This will be measured through the use of a validated DWELL questionnaire for actions related to changes in home environment for wellness. Secondary aims are to: 1) assess the effectiveness of the intervention on health behaviors, specifically in: nutrition, physical activity, smoke-free homes and hygiene; 2) improve awareness of the importance of the environment in healthy behavior; 3) improve wellness; 4) assess associations between level of participation (active social, active non-social, passive use) and other outcomes: DWELL, awareness of importance, health behaviors, and wellness.
Participants will be Israeli mothers who are at least 18 years old and have children up to 18 years old, who are willing to participate in the study, can read and write Hebrew, and have internet access and Facebook profile. Recruitment for the trial will be mainly through Facebook and WhatsApp. Semi-structured focus groups will be conducted in order to create DWELL content for intervention and the DWELL questionnaire to assess intervention's effectiveness.
A randomized controlled trial (RCT) will be conducted to assess effectiveness of an online intervention. Recruitment for the trial will be mainly through Facebook and WhatsApp. Sample size will be calculated based on initial results from the focus group's pilot. After recruitment, participants will be randomised into intervention and wait list control groups, using the online software "Research Randomizer". A three-month Facebook intervention will be carried out. Participants in both groups will fill pre, mid and post intervention questionnaires online. After the first 3 months of the intervention, the investigators will open the group to all participants, including those on the wait list control group. This will allow control group participants to access the treatment and to compensate the participants for participation. The investigators will continue to follow and manage the group and monitor its long-term activation.
A general linear model will be used which takes in to account repeated measures. A time-to-event analysis using Cox proportional hazards models will be conducted to examine the length of time for which change persisted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants who will be found suitable for participation and who will agree online to participate in the study, will be randomized into intervention and wait list control groups, using an online software "Research Randomizer". The wait list control group will not receive any special treatment during the study. Both groups will be asked to answer the online questionnaires, and after the end of the intervention period the wait list control group will get access to the Facebook group also, to compensate them for participation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Israeli mothers who are at least 18 years old and have children <=18 who are willing to participate in a social media (Facebook) intervention.
排除标准
- •Participant is not an Israeli woman.
- •Participant is not a mother.
- •Participant is under 18 years old.
- •Participant does not have at least one child up to 18 years old.
- •Participant is not willing to participate in the study.
- •Participant can not read and write Hebrew.
- •Participant does not have internet access.
- •Participant does not have Facebook profile. �
研究组 & 干预措施
Design For Wellness (DWELL)
Intervention participants will: 1) consume scientific evidence and practical solutions of how to design the home environment for wellness; 2) be part of a community which encourage participants engagement; 3) be empowered to read and control cues in the environment by developing skills.
干预措施: Design For Wellness (DWELL) (Behavioral)
Wait list control group
After the close of the study, we will open the Facebook group to all, and wait list control group participants can receive a delayed form of the intervention, which includes: 1) consume scientific evidence and practical solutions of how to design the home environment for wellness; 2) be part of a community which encourage participants engagement; 3) be empowered to read and control cues in the environment by developing skills.
干预措施: Wait list control group (Behavioral)
结局指标
主要结局
Change in home environment design for wellness, as assessed by DWELL questionnaire
时间窗: Baseline, 6 weeks and 3 months
DWELL
次要结局
- Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire(Baseline, 6 weeks and 3 months)
- level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: DWELL(Baseline, 6 weeks and 3 months)
- Change in overall wellness, as assessed by WHO-5 instrument(Baseline, 6 weeks and 3 months)
- Change in overall wellness, as assessed by I COPPE instrument(Baseline, 6 weeks and 3 months)
- level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: wellness(Baseline, 6 weeks and 3 months)
- level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: awareness of importance of design for wellness(Baseline, 6 weeks and 3 months)
- level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: health behaviors(Baseline, 6 weeks and 3 months)
- Changes in Health behaviors, as assessed by existing online questionnaires(Baseline, 6 weeks and 3 months)
研究者
Laura J. Rosen
Senior Lecturer, Dept. of Health Promotion
Tel Aviv University