Wellness Clinical Trial
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.
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.
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