Effectiveness of a Well-being Web-based Intervention

NCT ID: NCT01586949

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Focus of Study: Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment

Intervention: Daily Challenge

Group Type EXPERIMENTAL

Daily Challenge

Intervention Type BEHAVIORAL

Web-based behavioral intervention aiming to improve individuals' well-being.

Control

Weekly Well-being, an email-based health information delivery service.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Daily Challenge

Web-based behavioral intervention aiming to improve individuals' well-being.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Healthways, Inc.

INDUSTRY

Sponsor Role collaborator

MeYou Health, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josee Poirier, PhD

Role: PRINCIPAL_INVESTIGATOR

MeYou Health, LLC

Nathan K Cobb, MD

Role: STUDY_CHAIR

MeYou Health, LLC

Locations

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MeYou Health office

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Harrison PL, Pope JE, Coberley CR, Rula EY. Evaluation of the relationship between individual well-being and future health care utilization and cost. Popul Health Manag. 2012 Dec;15(6):325-30. doi: 10.1089/pop.2011.0089. Epub 2012 Feb 22.

Reference Type BACKGROUND
PMID: 22356589 (View on PubMed)

Prochaska JO, Evers KE, Castle PH, Johnson JL, Prochaska JM, Rula EY, Coberley C, Pope JE. Enhancing multiple domains of well-being by decreasing multiple health risk behaviors: a randomized clinical trial. Popul Health Manag. 2012 Oct;15(5):276-86. doi: 10.1089/pop.2011.0060. Epub 2012 Feb 21.

Reference Type BACKGROUND
PMID: 22352379 (View on PubMed)

Heesch KC, Masse LC, Dunn AL, Frankowski RF, Mullen PD. Does adherence to a lifestyle physical activity intervention predict changes in physical activity? J Behav Med. 2003 Aug;26(4):333-48. doi: 10.1023/a:1024205011001.

Reference Type BACKGROUND
PMID: 12921007 (View on PubMed)

Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, Greene S, Couper M, Carlier C, Wiese C, Little R, Pomerleau C, Pomerleau O. The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e36. doi: 10.2196/jmir.1002.

Reference Type BACKGROUND
PMID: 18984557 (View on PubMed)

Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.

Reference Type BACKGROUND
PMID: 12574618 (View on PubMed)

Hill JO. Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16.

Reference Type BACKGROUND
PMID: 19088151 (View on PubMed)

Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.

Reference Type BACKGROUND
PMID: 15829473 (View on PubMed)

Christakis NA. Social networks and collateral health effects. BMJ. 2004 Jul 24;329(7459):184-5. doi: 10.1136/bmj.329.7459.184. No abstract available.

Reference Type BACKGROUND
PMID: 15271805 (View on PubMed)

Christakis NA, Fowler JH. The spread of obesity in a large social network over 32 years. N Engl J Med. 2007 Jul 26;357(4):370-9. doi: 10.1056/NEJMsa066082. Epub 2007 Jul 25.

Reference Type BACKGROUND
PMID: 17652652 (View on PubMed)

Christakis NA. Health care in a web. BMJ. 2008 Jun 28;336(7659):1468. doi: 10.1136/bmj.a452.

Reference Type BACKGROUND
PMID: 18583678 (View on PubMed)

Pew Research Center. Social networking sites and our lives (Report). 2011. http:/pewinternet.org/Reports/2011/Technology-and-social-networks.aspx

Reference Type BACKGROUND

Helliwell JF, Putnam RD. The social context of well-being. Philos Trans R Soc Lond B Biol Sci. 2004 Sep 29;359(1449):1435-46. doi: 10.1098/rstb.2004.1522.

Reference Type BACKGROUND
PMID: 15347534 (View on PubMed)

Stata analysis software. Stata Corporation, College Station, TX.

Reference Type BACKGROUND

Tabachnick, B.G. and Fidell, L.S. Using multivariate statistics, 4th Edition, Allyn & Bacon, Needham, MA. 2001.

Reference Type BACKGROUND

Fleiss, J.L. Design and Analysis of Clinical Experiments.1999. Wiley, New York, NY.

Reference Type BACKGROUND

MacKinnon DP, Fairchild AJ, Fritz MS. Mediation analysis. Annu Rev Psychol. 2007;58:593-614. doi: 10.1146/annurev.psych.58.110405.085542.

Reference Type BACKGROUND
PMID: 16968208 (View on PubMed)

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.

Reference Type BACKGROUND

Zellner, A. An efficient method of estimating seemingly unrelated regressions and tests for aggregation bias. J Am Stat Assoc, 57(348-68), 1962.

Reference Type BACKGROUND

Lin DY, Fleming TR, De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med. 1997 Jul 15;16(13):1515-27. doi: 10.1002/(sici)1097-0258(19970715)16:133.0.co;2-1.

Reference Type BACKGROUND
PMID: 9249922 (View on PubMed)

Vittinghoff E, Sen S, McCulloch CE. Sample size calculations for evaluating mediation. Stat Med. 2009 Feb 15;28(4):541-57. doi: 10.1002/sim.3491.

Reference Type BACKGROUND
PMID: 19065627 (View on PubMed)

Gleason, T.C. and Staelin, R. A proposal for handling missing data. Psychometrika, 40(2): 229-252, 1975.

Reference Type BACKGROUND

Little, R.J. and Rubin, D.B. Statistical analysis with missing data, 2nd Edition, Wiley, New York, NY. 2002.

Reference Type BACKGROUND

Schafer, J. L. Analysis of Incomplete Multivariate Data. New York, NY: Chapman & Hall, CRC. 2002.

Reference Type BACKGROUND

Cobb NK, Poirier J. Effectiveness of a multimodal online well-being intervention: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):41-8. doi: 10.1016/j.amepre.2013.08.018.

Reference Type DERIVED
PMID: 24355670 (View on PubMed)

Other Identifiers

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DC-EFF-2012

Identifier Type: -

Identifier Source: org_study_id

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