A Phase 1/2 interventional study of Design For Wellness (DWELL) and Wait list control group in Design For Wellness and Wellness, sponsored by Laura J. Rosen. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-31.
Sponsored by Laura J. Rosen · Phase 1/2, Interventional, and Other
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.
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.
Laura J. Rosen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Israeli mothers who are at least 18 years old and have children \<=18 who are willing to participate in a social media (Facebook) intervention.
Exclusion Criteria:
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.
Behavioral: Design For Wellness (DWELL)
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.
Behavioral: Wait list control group
Design for wellness is an online Facebook intervention. During 3 months intervention period, participants in the intervention group will be exposed to contents on their newsfeed (posts on Facebook wall), and also be expected and encouraged to create new content themselves. The contents will be interactive and involve different modes of delivery, as audio and video, to reinforce active learning. Participants will be part of DWELL Facebook group community and will be empowered to read and control cues in the environment, by developing skills to enhance their self-efficacy.
Wait list control group will get no intervention during the study period. Participants will answer questionnaires pre, mid and post intervention. A delayed form of the intervention will be available to them after the close of the study.
Change in home environment design for wellness, as assessed by DWELL questionnaire
DWELL
Time frame: Baseline, 6 weeks and 3 months
Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire
Awareness of the importance of the environment
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: healthy nutrition
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: physical activity
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: smoke-free homes
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: good hygiene
Time frame: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by WHO-5 instrument
Overall wellness
Time frame: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by I COPPE instrument
Overall wellness
Time frame: 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
Level of participation
Time frame: 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
Level of participation
Time frame: 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
Level of participation
Time frame: 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
Level of participation
Time frame: Baseline, 6 weeks and 3 months
Plan to share: No
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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Laura J. Rosen