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DWELL: Design For Wellness - An Online Intervention To Create Healthier Home Environments

NCT ID: NCT03736525

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-25

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Design For Wellness Wellness

Keywords

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Wellness Home environment Design Online intervention Randomized Controlled Trail (RCT) Nudge theory Mothers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Design For Wellness (DWELL)

Intervention Type BEHAVIORAL

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

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.

Group Type OTHER

Wait list control group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Wait list control group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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. �
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

Laura J. Rosen

OTHER

Sponsor Role lead

Responsible Party

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Laura J. Rosen

Senior Lecturer, Dept. of Health Promotion

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tal Aperman-Itzhak, PhD Student

Role: STUDY_DIRECTOR

School of Public Health, Dept. of Health Promotion, Sackler Faculty of Medicine, Tel Aviv University

Locations

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Tel Aviv University

Tel Aviv, Ramat Aviv, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Laura J Rosen, Phd

Role: CONTACT

Phone: +972 50-875-1502

Email: [email protected]

Isaac Prilleltensky, Phd

Role: CONTACT

Phone: 305-284-3505

Email: [email protected]

Facility Contacts

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Tal Aperman-Itzhak, PhD Student

Role: primary

Laura J Rosen, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37934566 (View on PubMed)

Other Identifiers

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141.18

Identifier Type: -

Identifier Source: org_study_id