Design For WellnessPhase 1/2NCT03736525
DWELL: Design For Wellness - An Online Intervention To Create Healthier Home Environments
A Phase 1/2 study testing Design For Wellness (DWELL) in people with Design For Wellness and Wellness, run by Laura J. Rosen at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Design For Wellness, Wellness
- What is being tested?
- Design For Wellness (DWELL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Nov 2018to Jul 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Israeli mothers who are at least 18 years old and have children <=18 who are willing to participate in a social media (Facebook) intervention.
Who cannot join
- 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. �
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, Ramat Aviv, 69978
Tal Aperman-Itzhak, PhD Student, +972 50-834-2585, talap1@gmail.com
Laura J Rosen, PhD, +972 50-875-1502, rosenl@post.tau.ac.il
About this study
Official title: DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments
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.
Read the 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.
- Conditions
- Design For Wellness, Wellness
- Being tested
- Design For Wellness (DWELL), Wait list control group
- Keywords
- Wellness, Home environment, Design, Online intervention, Randomized Controlled Trail (RCT), Nudge theory, Mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Design For Wellness (DWELL)Behavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Design For Wellness (DWELL) | Experimental | 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. Receives: Behavioral: Design For Wellness (DWELL) |
| Wait list control group | Other | 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. Receives: Behavioral: Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in home environment design for wellness, as assessed by DWELL questionnaire
DWELL
Measured: Baseline, 6 weeks and 3 months
Secondary outcomes (11)
Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire
Awareness of the importance of the environment
Measured: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: healthy nutrition
Measured: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: physical activity
Measured: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: smoke-free homes
Measured: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Health behaviors: good hygiene
Measured: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by WHO-5 instrument
Overall wellness
Measured: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by I COPPE instrument
Overall wellness
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start25 Nov 2018
- Primary completionOct 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Design For WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized online to intervention and wait list control groups. Intervention group only will be exposed to a new Facebook group, opened specifically for this study. The Facebook group will have a privacy setting of "closed group", meaning that only members of the group can see posts. This is to prevent possible contamination, ensuring that members of the control group will not be exposed to the intervention. The intervention period will be 3 months. Participants in both groups will fill pre, mid and post intervention questionnaires. At the end of 3 months, we will change the settings of the group and open it to all, including the wait list control group. That way the control group will get access to the treatment as well, to compensate them for participation.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura J. Rosen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor-investigator, Laura J. Rosen, Tel Aviv University
- Investigators
- Tal Aperman-Itzhak, PhD Student, Study director, School of Public Health, Dept. of Health Promotion, Sackler Faculty of Medicine, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736525
- Sponsor's protocol ID
- 141.18
- Status last verified
- Dec 2018
- First submitted
- 24 Oct 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aperman-Itzhak T, Prilleltensky I, Rosen L. Improving Knowledge, Engagement, and Self-Efficacy in the Creation of Healthy Home Environments for Mothers Using a Facebook Intervention (Design for Wellness): Randomized Controlled Trial. J Med Internet Res. 2023 Nov 7;25:e46640. doi: 10.2196/46640.
PubMed 37934566
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments
- ClinicalTrials.gov ID
- NCT03736525
- Acronym / sponsor ID
- 141.18
- Conditions
- Design For Wellness, Wellness
- Keywords
- Wellness, Home environment, Design, Online intervention, Randomized Controlled Trail (RCT), Nudge theory, Mothers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Laura J. RosenUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized online to intervention and wait list control groups. Intervention group only will be exposed to a new Facebook group, opened specifically for this study. The Facebook group will have a privacy setting of "closed group", meaning that only members of the group can see posts. This is to prevent possible contamination, ensuring that members of the control group will not be exposed to the intervention. The intervention period will be 3 months. Participants in both groups will fill pre, mid and post intervention questionnaires. At the end of 3 months, we will change the settings of the group and open it to all, including the wait list control group. That way the control group will get access to the treatment as well, to compensate them for participation.
| Arm | Type | Receives |
|---|---|---|
| Design For Wellness (DWELL) | Experimental | Behavioral: 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. |
| Wait list control group | Other | Behavioral: Wait list control groupAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Israeli mothers who are at least 18 years old and have children <=18 who are willing to participate in a social media (Facebook) intervention.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Design For Wellness (DWELL)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. | Behavioural | Design For Wellness (DWELL) |
| Wait list control groupWait 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. | Behavioural | Wait list control group |
Primary outcome
Change in home environment design for wellness, as assessed by DWELL questionnaire
Time frame: Baseline, 6 weeks and 3 months
DWELL
11 secondary outcomes
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
Changes in Health behaviors, as assessed by existing online questionnaires
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Time frame: Baseline, 6 weeks and 3 months
Changes in Health behaviors, as assessed by existing online questionnaires
Time frame: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by WHO-5 instrument
Time frame: Baseline, 6 weeks and 3 months
Change in overall wellness, as assessed by I COPPE instrument
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
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
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
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
Time frame: Baseline, 6 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Derived from this study: PubMed 37934566Aperman-Itzhak T, Prilleltensky I, Rosen L. Improving Knowledge, Engagement, and Self-Efficacy in the Creation of Healthy Home Environments for Mothers Using a Facebook Intervention (Design for Wellness): Randomized Controlled Trial. J Med Internet Res. 2023 Nov 7;25:e46640. doi: 10.2196/46640.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tal Aperman-Itzhak, PhD Student study director
School of Public Health, Dept. of Health Promotion, Sackler Faculty of Medicine, Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Design For Wellness (DWELL) in people with Design For Wellness and Wellness, run by Laura J. Rosen at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura J Rosen, Phd (+972 50-875-1502, rosenl@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in home environment design for wellness, as assessed by DWELL questionnaire (time frame: Baseline, 6 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.