NCT03736525

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

October 24, 2018

Last Update Submit

December 27, 2018

Conditions

Keywords

WellnessHome environmentDesignOnline interventionRandomized Controlled Trail (RCT)Nudge theoryMothers

Outcome Measures

Primary Outcomes (1)

  • Change in home environment design for wellness, as assessed by DWELL questionnaire

    DWELL

    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

    Baseline, 6 weeks and 3 months

  • Changes in Health behaviors, as assessed by existing online questionnaires

    Baseline, 6 weeks and 3 months

  • Changes in Health behaviors, as assessed by existing online questionnaires

    Baseline, 6 weeks and 3 months

  • Changes in Health behaviors, as assessed by existing online questionnaires

    Baseline, 6 weeks and 3 months

  • Changes in Health behaviors, as assessed by existing online questionnaires

    Baseline, 6 weeks and 3 months

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Wait list control group

Interventions

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.

Design For Wellness (DWELL)

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.

Wait list control group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIsraeli mothers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Israeli mothers who are at least 18 years old and have children \<=18 who are willing to participate in a social media (Facebook) intervention.

You may not qualify if:

  • 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. �

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Ramat Aviv, 69978, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Research DesignHealth

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesPopulation Characteristics

Study Officials

  • Tal Aperman-Itzhak, PhD Student

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

    STUDY DIRECTOR

Central Study Contacts

Laura J Rosen, Phd

CONTACT

Isaac Prilleltensky, Phd

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer, Dept. of Health Promotion

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 9, 2018

Study Start

November 25, 2018

Primary Completion

October 1, 2020

Study Completion

July 1, 2021

Last Updated

December 31, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations