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

Wellness Clinical Trial

Official title:

DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03736525
• Other study ID #: 141.18
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 25, 2018
• Est. completion date: July 2021

Study information

• Verified date: December 2018
• Source: Tel Aviv University
• Contact: Laura J Rosen, Phd
• Phone: +972 50-875-1502
• Email: rosenl[@]post.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. ?

Related Conditions & MeSH terms

• Design For Wellness
• Wellness

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv	Ramat Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Laura J. Rosen	University of Miami

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in home environment design for wellness, as assessed by DWELL questionnaire	DWELL	Baseline, 6 weeks and 3 months
Secondary	Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire	Awareness of the importance of the environment	Baseline, 6 weeks and 3 months
Secondary	Changes in Health behaviors, as assessed by existing online questionnaires	Health behaviors: healthy nutrition	Baseline, 6 weeks and 3 months
Secondary	Changes in Health behaviors, as assessed by existing online questionnaires	Health behaviors: physical activity	Baseline, 6 weeks and 3 months
Secondary	Changes in Health behaviors, as assessed by existing online questionnaires	Health behaviors: smoke-free homes	Baseline, 6 weeks and 3 months
Secondary	Changes in Health behaviors, as assessed by existing online questionnaires	Health behaviors: good hygiene	Baseline, 6 weeks and 3 months
Secondary	Change in overall wellness, as assessed by WHO-5 instrument	Overall wellness	Baseline, 6 weeks and 3 months
Secondary	Change in overall wellness, as assessed by I COPPE instrument	Overall wellness	Baseline, 6 weeks and 3 months
Secondary	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	Baseline, 6 weeks and 3 months
Secondary	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	Baseline, 6 weeks and 3 months
Secondary	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	Baseline, 6 weeks and 3 months
Secondary	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	Baseline, 6 weeks and 3 months