- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736525
DWELL: Design For Wellness - An Online Intervention To Create Healthier Home Environments
DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Laura J Rosen, PhD
- Phone Number: +972 50-875-1502
- Email: rosenl@post.tau.ac.il
Study Contact Backup
- Name: Isaac Prilleltensky, Phd
- Phone Number: 305-284-3505
- Email: isaacp@miami.edu
Study Locations
-
-
Ramat Aviv
-
Tel Aviv, Ramat Aviv, Israel, 69978
- Recruiting
- Tel Aviv University
-
Contact:
- Laura J Rosen, PhD
- Phone Number: +972 50-875-1502
- Email: rosenl@post.tau.ac.il
-
Contact:
- Tal Aperman-Itzhak, PhD Student
- Phone Number: +972 50-834-2585
- Email: talap1@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
- 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. �
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in home environment design for wellness, as assessed by DWELL questionnaire
Time Frame: Baseline, 6 weeks and 3 months
|
DWELL
|
Baseline, 6 weeks and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire
Time Frame: Baseline, 6 weeks and 3 months
|
Awareness of the importance of the environment
|
Baseline, 6 weeks and 3 months
|
Changes in Health behaviors, as assessed by existing online questionnaires
Time Frame: Baseline, 6 weeks and 3 months
|
Health behaviors: healthy nutrition
|
Baseline, 6 weeks and 3 months
|
Changes in Health behaviors, as assessed by existing online questionnaires
Time Frame: Baseline, 6 weeks and 3 months
|
Health behaviors: physical activity
|
Baseline, 6 weeks and 3 months
|
Changes in Health behaviors, as assessed by existing online questionnaires
Time Frame: Baseline, 6 weeks and 3 months
|
Health behaviors: smoke-free homes
|
Baseline, 6 weeks and 3 months
|
Changes in Health behaviors, as assessed by existing online questionnaires
Time Frame: Baseline, 6 weeks and 3 months
|
Health behaviors: good hygiene
|
Baseline, 6 weeks and 3 months
|
Change in overall wellness, as assessed by WHO-5 instrument
Time Frame: Baseline, 6 weeks and 3 months
|
Overall wellness
|
Baseline, 6 weeks and 3 months
|
Change in overall wellness, as assessed by I COPPE instrument
Time Frame: Baseline, 6 weeks and 3 months
|
Overall 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: DWELL
Time Frame: Baseline, 6 weeks and 3 months
|
Level of participation
|
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
Time Frame: Baseline, 6 weeks and 3 months
|
Level of participation
|
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
Time Frame: Baseline, 6 weeks and 3 months
|
Level of participation
|
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
Time Frame: Baseline, 6 weeks and 3 months
|
Level of participation
|
Baseline, 6 weeks and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Tal Aperman-Itzhak, PhD Student, School of Public Health, Dept. of Health Promotion, Sackler Faculty of Medicine, Tel Aviv University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 141.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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