Focus of Study: Healthy IndividualsNCT01586949
Effectiveness of a Well-being Web-based Intervention
A study testing Daily Challenge in people with Focus of Study: Healthy Individuals, run by MeYou Health, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Healthy Individuals
- What is being tested?
- Daily Challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,503 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of the Web-based Well-being Intervention Daily Challenge
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.
- Conditions
- Focus of Study: Healthy Individuals
- Being tested
- Daily Challenge
- Keywords
- well-being, web-based intervention, social networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily ChallengeBehavioural
Web-based behavioral intervention aiming to improve individuals' well-being.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intervention: Daily Challenge Receives: Behavioral: Daily Challenge |
| Control | No intervention | Weekly Well-being, an email-based health information delivery service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being score, as determined by the Healthways Well-Being Assessment
Change in well-being score
Measured: Baseline, 30 days, 90 days
Secondary outcomes (1)
Interpersonal support score, as evaluated with the Interpersonal Support Evaluation List (ISEL)
Change in interpersonal support score.
Measured: Baseline, 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,503 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeYou Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healthways, Inc.
- Responsible party
- Sponsor
- Investigators
- Josee Poirier, PhD, Principal investigator, MeYou Health, LLCNathan K Cobb, MD, Study chair, MeYou Health, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586949
- Sponsor's protocol ID
- DC-EFF-2012
- Status last verified
- Sep 2015
- First submitted
- 25 Apr 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22356589Prochaska 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.
PubMed 22352379Heesch 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.
PubMed 12921007Strecher 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.
PubMed 18984557Hill 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.
PubMed 12574618Hill 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.
PubMed 19088151Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.
PubMed 15829473Christakis 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.
PubMed 15271805Christakis 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.
PubMed 17652652Christakis NA. Health care in a web. BMJ. 2008 Jun 28;336(7659):1468. doi: 10.1136/bmj.a452.
PubMed 18583678Pew Research Center. Social networking sites and our lives (Report). 2011. http:/pewinternet.org/Reports/2011/Technology-and-social-networks.aspx
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.
PubMed 15347534Stata 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of the Web-based Well-being Intervention Daily Challenge
- ClinicalTrials.gov ID
- NCT01586949
- Acronym / sponsor ID
- DC-EFF-2012
- Conditions
- Focus of Study: Healthy Individuals
- Keywords
- well-being, web-based intervention, social networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,503 participants (actual)
- Lead sponsor
- MeYou Health, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Healthways, Inc.
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Daily ChallengeIntervention: Daily Challenge |
| Control | No intervention | –Weekly Well-being, an email-based health information delivery service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily ChallengeWeb-based behavioral intervention aiming to improve individuals' well-being. | Behavioural | Treatment |
Primary outcome
Well-being score, as determined by the Healthways Well-Being Assessment
Time frame: Baseline, 30 days, 90 days
Change in well-being score
1 secondary outcome
Interpersonal support score, as evaluated with the Interpersonal Support Evaluation List (ISEL)
Time frame: Baseline, 30 days, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Background: PubMed 22356589Harrison 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.
- Background: PubMed 22352379Prochaska 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.
- Background: PubMed 12921007Heesch 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.
- Background: PubMed 18984557Strecher 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.
- Background: PubMed 12574618Hill 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.
- Background: PubMed 19088151Hill 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.
- Background: PubMed 15829473Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.
- Background: PubMed 15271805Christakis 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.
- Background: PubMed 17652652Christakis 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.
- Background: PubMed 18583678Christakis NA. Health care in a web. BMJ. 2008 Jun 28;336(7659):1468. doi: 10.1136/bmj.a452.
- BackgroundPew Research Center. Social networking sites and our lives (Report). 2011. http:/pewinternet.org/Reports/2011/Technology-and-social-networks.aspx
- Background: PubMed 15347534Helliwell 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.
Related trials for Focus of Study: Healthy Individuals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josee Poirier, PhD principal investigator
MeYou Health, LLC
Nathan K Cobb, MD study chair
MeYou Health, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Challenge in people with Focus of Study: Healthy Individuals, run by MeYou Health, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being score, as determined by the Healthways Well-Being Assessment (time frame: Baseline, 30 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01586949, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.