Clinical trial NCT03736525: DWELL: Design For Wellness - An Online Intervention To Create Healthier Home Environments
Official title: DWELL: Design For Wellness - An Online, Randomized Controlled Trial To Create Healthier Home Environments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Design For Wellness
Wellness
Keywords: Wellness
Home environment
Design
Online intervention
Randomized Controlled Trail (RCT)
Nudge theory
Mothers
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2018-11-09
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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. �

Primary outcomes:
measure: Change in home environment design for wellness, as assessed by DWELL questionnaire
timeFrame: Baseline, 6 weeks and 3 months
Secondary outcomes:
measure: Change in awareness of the importance of the environment in healthy behaviors, as assessed by DWELL questionnaire
timeFrame: Baseline, 6 weeks and 3 months
measure: Changes in Health behaviors, as assessed by existing online questionnaires
timeFrame: Baseline, 6 weeks and 3 months
measure: Changes in Health behaviors, as assessed by existing online questionnaires
timeFrame: Baseline, 6 weeks and 3 months
measure: Changes in Health behaviors, as assessed by existing online questionnaires
timeFrame: Baseline, 6 weeks and 3 months
measure: Changes in Health behaviors, as assessed by existing online questionnaires
timeFrame: Baseline, 6 weeks and 3 months
measure: Change in overall wellness, as assessed by WHO-5 instrument
timeFrame: Baseline, 6 weeks and 3 months
measure: Change in overall wellness, as assessed by I COPPE instrument
timeFrame: Baseline, 6 weeks and 3 months
measure: level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: DWELL
timeFrame: Baseline, 6 weeks and 3 months
measure: 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
timeFrame: Baseline, 6 weeks and 3 months
measure: level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: health behaviors
timeFrame: Baseline, 6 weeks and 3 months
measure: level of participation in the online Facebook group (active social, active non-social, passive use) will be associated with the outcome: wellness
timeFrame: Baseline, 6 weeks and 3 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
state: Ramat Aviv
Study officials:
affiliation: School of Public Health, Dept. of Health Promotion, Sackler Faculty of Medicine, Tel Aviv University
name: Tal Aperman-Itzhak, PhD Student
role: STUDY_DIRECTOR
References: