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Effectiveness of a Well-being Web-based Intervention

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ClinicalTrials.gov Identifier: NCT01586949
Recruitment Status : Completed
First Posted : April 27, 2012
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Healthways, Inc.
Information provided by (Responsible Party):
MeYou Health, LLC

Brief Summary:
The purpose of this study is to determine whether the intervention Daily Challenge (MeYou Health, LLC), a behavioral intervention delivered online, is effective in improving individuals' well-being.

Condition or disease Intervention/treatment Phase
Focus of Study: Healthy Individuals Behavioral: Daily Challenge Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effectiveness of the Web-based Well-being Intervention Daily Challenge
Study Start Date : April 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Treatment
Intervention: Daily Challenge
Behavioral: Daily Challenge
Web-based behavioral intervention aiming to improve individuals' well-being.

No Intervention: Control
Weekly Well-being, an email-based health information delivery service.



Primary Outcome Measures :
  1. Well-being score, as determined by the Healthways Well-Being Assessment [ Time Frame: Baseline, 30 days, 90 days ]
    Change in well-being score


Secondary Outcome Measures :
  1. Interpersonal support score, as evaluated with the Interpersonal Support Evaluation List (ISEL) [ Time Frame: Baseline, 30 days, 90 days ]
    Change in interpersonal support score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults (18 years of age or older, 19 years of age or older if participant resides in Alabama or Nebraska)
  • Provided informed consent to participate in the study

Exclusion Criteria:

  • Does not live in the United States of America
  • Has a Facebook friend enrolled in the study
  • Fails to complete the informed consent and registration process in the allotted time (45 minutes)
  • Gender (recruitment will be titrated to ensure a minimum of 30% male ratio)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586949


Locations
United States, Massachusetts
MeYou Health office
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
MeYou Health, LLC
Healthways, Inc.
Investigators
Principal Investigator: Josee Poirier, PhD MeYou Health, LLC
Study Chair: Nathan K Cobb, MD MeYou Health, LLC

Additional Information:
Publications:
Pew Research Center. Social networking sites and our lives (Report). 2011. http:/pewinternet.org/Reports/2011/Technology-and-social-networks.aspx
Stata analysis software. Stata Corporation, College Station, TX.
Tabachnick, B.G. and Fidell, L.S. Using multivariate statistics, 4th Edition, Allyn & Bacon, Needham, MA. 2001.
Fleiss, J.L. Design and Analysis of Clinical Experiments.1999. Wiley, New York, NY.
Beasley, T.M. Seemingly unrelated regression (SUR) models as a solution to path analytic models with correlated errors. Multiple Linear Regression Viewpoints. 34(1): 1-7, 2008.
Zellner, A. An efficient method of estimating seemingly unrelated regressions and tests for aggregation bias. J Am Stat Assoc, 57(348-68), 1962.
Gleason, T.C. and Staelin, R. A proposal for handling missing data. Psychometrika, 40(2): 229-252, 1975.
Little, R.J. and Rubin, D.B. Statistical analysis with missing data, 2nd Edition, Wiley, New York, NY. 2002.
Schafer, J. L. Analysis of Incomplete Multivariate Data. New York, NY: Chapman & Hall, CRC. 2002.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MeYou Health, LLC
ClinicalTrials.gov Identifier: NCT01586949     History of Changes
Other Study ID Numbers: DC-EFF-2012
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by MeYou Health, LLC:
well-being
web-based intervention
social networks