Cardiovascular DiseaseINSHAPENCT01421758
Testing the Efficacy of an Online Social Network Intervention to Increase Social Support for Physical Activity
A study testing online social network enrollment plus education and self monitoring in people with Cardiovascular Disease and Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. Read more about this study
- Who is it for?
- Ages 17 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Cancer, Obesity
- What is being tested?
- online social network enrollment plus education and self monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2011
- 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 17 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female
- under the age of 25
- currently enrolled full time or part time student at the University of North Carolina at Chapel Hill
- classified as an undergraduate
- answers no to all questions on an exercise risk factor questionnaire (PAR-Q) or is cleared in writing by a physician to participate in an independent exercise program
- a score of less than 3 on the SCOFF eating disorders questionnaire
Show all 11Show fewer
- less than 30 minutes per day of self reported moderate or vigorous physical activity
- regular Facebook use as defined by self reported owning of an account and use of at least 30 minutes per day
- willing to provide informed consent
- willing to participate in the intervention
- literate in the English language.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Using Facebook to Increase Social Support for Physical Activity: The INSHAPE Study
This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. The investigators hypothesize that participants in the physical activity centered online social network intervention group will have greater increases in perceived social support for physical activity compared to minimal web based physical activity education controls.
- Conditions
- Cardiovascular Disease, Cancer, Obesity
- Being tested
- online social network enrollment plus education and self monitoring, Web education control
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online social network enrollment plus education and self monitoringBehavioural
Participants are enrolled in an online social network designed to increase social support for physical activity and will self monitor physical activity and receive educational materials at a dedicated study website.
Web education controlBehavioural
Participants will receive access to a dedicated study website where they can view educational materials related to physical activity
| Study group | Role | What they receive |
|---|---|---|
| online social network | Experimental | Not described Receives: Behavioral: online social network enrollment plus education and self monitoring |
| web education control | Active comparator | Not described Receives: Behavioral: Web education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean perceived social support for physical activity scores on the Peer/Friend Support for Healthy Eating and Physical Activity Scale.
The primary outcome measure is the mean score of a 19 item, 7 point scale that measures the frequency of social support interactions over the previous 6 weeks.
Measured: 10 weeks
Secondary outcomes (1)
Physical activity in kilocalories on the Paffenbarger Physical Activity Questionnaire/College Alumnus Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Cavallo, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421758
- Sponsor's protocol ID
- 10-1122
- Acronym
- INSHAPE
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2011
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cavallo DN, Tate DF, Ries AV, Brown JD, DeVellis RF, Ammerman AS. A social media-based physical activity intervention: a randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):527-32. doi: 10.1016/j.amepre.2012.07.019.
PubMed 23079176
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Facebook to Increase Social Support for Physical Activity: The INSHAPE Study
- ClinicalTrials.gov ID
- NCT01421758
- Acronym / sponsor ID
- INSHAPE / 10-1122
- Conditions
- Cardiovascular Disease, Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Aug 2011 (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.
This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. The investigators hypothesize that participants in the physical activity centered online social network intervention group will have greater increases in perceived social support for physical activity compared to minimal web based physical activity education controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online social network | Experimental | Behavioral: online social network enrollment plus education and self monitoring |
| web education control | Active comparator | Behavioral: Web education control |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- female
- under the age of 25
- currently enrolled full time or part time student at the University of North Carolina at Chapel Hill
- classified as an undergraduate
- answers no to all questions on an exercise risk factor questionnaire (PAR-Q) or is cleared in writing by a physician to participate in an independent exercise program
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| online social network enrollment plus education and self monitoringParticipants are enrolled in an online social network designed to increase social support for physical activity and will self monitor physical activity and receive educational materials at a dedicated study website. | Behavioural | online social network |
| Web education controlParticipants will receive access to a dedicated study website where they can view educational materials related to physical activity | Behavioural | web education control |
Primary outcome
Mean perceived social support for physical activity scores on the Peer/Friend Support for Healthy Eating and Physical Activity Scale.
Time frame: 10 weeks
The primary outcome measure is the mean score of a 19 item, 7 point scale that measures the frequency of social support interactions over the previous 6 weeks.
1 secondary outcome
Physical activity in kilocalories on the Paffenbarger Physical Activity Questionnaire/College Alumnus Questionnaire
Time frame: 12 weeks
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 19 Apr 2016.
- Derived from this study: PubMed 23079176Cavallo DN, Tate DF, Ries AV, Brown JD, DeVellis RF, Ammerman AS. A social media-based physical activity intervention: a randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):527-32. doi: 10.1016/j.amepre.2012.07.019.
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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.
David N Cavallo, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online social network enrollment plus education and self monitoring in people with Cardiovascular Disease and Cancer, run by University of North Carolina, Chapel Hill 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 11 inclusion and 0 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 19 Apr 2016. 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?
Mean perceived social support for physical activity scores on the Peer/Friend Support for Healthy Eating and Physical Activity Scale. (time frame: 10 weeks). 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 NCT01421758, which also lists 1 linked publication.
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 19 Apr 2016.