SedentaryPhase 1NCT01593449
A Community-based Social Networking Intervention to Increase Walking in Dog Owners
A Phase 1 study testing Community-based social networking intervention in people with Sedentary, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
The present study aims to initially test a community dog walking intervention that addresses individual, interpersonal and community factors associated with dog walking. The study will be conducted in two cities, Worcester and Lowell, as a collaboration between investigators from UMass Medical School and UMass-Lowell. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary
- What is being tested?
- Community-based social networking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants will own a dog that is in good health and considered a household pet, be a Worcester or Lowell resident, be aged > 21 years old and have home internet access. Participants with cardiovascular disease, diabetes or other chronic health condition are eligible with permission from their PCP to participate.
Who cannot join
- Participants will be excluded for any of the following:
- Inability or unwillingness to give informed consent
- Plans to move out of the area within the study period
- Participated in a focus group during the developmental phase
- Another household member is participating in the study
- Pregnant or planning a pregnancy in the next six months
Show all 10Show fewer
- Condition that inhibits exercise (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
- Incapable of engaging in physical activity as assessed by the Physical Activity Readiness Questionnaire
- Self-report engaging in > 150 minutes of moderate and vigorous intensity physical activity per week.
- The participant's dog has a history of biting a human or has not received a rabies vaccination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Massachusetts Lowell
Lowell, Massachusetts, 01854
University of Massachusetts Medical Schol
Worcester, Massachusetts, 01655
About this study
The present study aims to initially test a community dog walking intervention that addresses individual, interpersonal and community factors associated with dog walking. The study will be conducted in two cities, Worcester and Lowell, as a collaboration between investigators from UMass Medical School and UMass-Lowell.
Read the detailed description
This is a group randomized trial where 8 communities in Worcester and Lowell (4 per city) will be randomly assigned to the 6-month dog walking intervention or a standard, self-help, print-based physical activity control condition. Dog owners (N=120; 15 per community) will be recruited. The intervention includes a social networking website, monthly newsletters, twice monthly neighborhood dog walks and community events. The intervention will: 1) educate owners about the benefits of dog walking to themselves and their dog, 2) teach strategies for regular dog walking, 3) teach dog walking tips and provide dog training seminars, 4) promote self-monitoring and goal setting for dog walking, 5) provide social networking opportunities for dog owners and 6) promote a sense of community via participation in neighborhood dog walks and community events. Intervention feasibility will be assessed by measures of implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events. Initial efficacy will be assessed via change in weekly steps measured via a pedometer from baseline to 6-months after baseline.
- Conditions
- Sedentary
- Being tested
- Community-based social networking intervention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based social networking interventionBehavioural
Participation in this study lasts for 7 months and includes a baseline visit, an orientation visit, the 6 month intervention, and a 6 month assessment visit.
| Study group | Role | What they receive |
|---|---|---|
| American Heart Association | Active comparator | Participants will receive handouts on increasing physical activity derived from the American Heart Association materials on increasing physical activity. Receives: Behavioral: Community-based social networking intervention |
| Dog Walking | Experimental | The 6-month dog walking intervention involves 5 components to address the individual, interpersonal and community levels of the socio-ecological model: newsletters, pedometers, social networking website, neighborhood dog walks, and invitations to community events. Receives: Behavioral: Community-based social networking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
Feasibility will be assessed by implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events.
Measured: 6 months
Secondary outcomes (4)
Weekly steps
Pedometers that record 7-days of data will be used to measure steps at baseline and 6 months
Measured: baseline and 6 months
weekly dog walking minutes
Self-reported minutes of dog walking measured using the DAPA tool.
Measured: baseline and 6 months
social support for walking
Self-reported social support for walking
Measured: baseline and 6 months
sense of community
self-reported sense of community
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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 SedentaryStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Lowell
- Responsible party
- Principal investigator, Kristin Schneider, Rosalind Franklin University of Medicine and Science
- Investigators
- Krisitin Schneider, Ph.D., Principal investigator, Rosalind Franklin Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593449
- Sponsor's protocol ID
- NIH 5 UL1RR031982-02
- Status last verified
- Apr 2013
- First submitted
- 30 Apr 2012
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schneider KL, Murphy D, Ferrara C, Oleski J, Panza E, Savage C, Gada K, Bozzella B, Olendzki E, Kern D, Lemon SC. An online social network to increase walking in dog owners: a randomized trial. Med Sci Sports Exerc. 2015 Mar;47(3):631-9. doi: 10.1249/MSS.0000000000000441.
PubMed 25003777
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Social Networking Intervention to Increase Walking in Dog Owners
- ClinicalTrials.gov ID
- NCT01593449
- Acronym / sponsor ID
- NIH 5 UL1RR031982-02
- Conditions
- Sedentary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Lowell
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 May 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 present study aims to initially test a community dog walking intervention that addresses individual, interpersonal and community factors associated with dog walking. The study will be conducted in two cities, Worcester and Lowell, as a collaboration between investigators from UMass Medical School and UMass-Lowell.
Detailed description
This is a group randomized trial where 8 communities in Worcester and Lowell (4 per city) will be randomly assigned to the 6-month dog walking intervention or a standard, self-help, print-based physical activity control condition. Dog owners (N=120; 15 per community) will be recruited. The intervention includes a social networking website, monthly newsletters, twice monthly neighborhood dog walks and community events. The intervention will: 1) educate owners about the benefits of dog walking to themselves and their dog, 2) teach strategies for regular dog walking, 3) teach dog walking tips and provide dog training seminars, 4) promote self-monitoring and goal setting for dog walking, 5) provide social networking opportunities for dog owners and 6) promote a sense of community via participation in neighborhood dog walks and community events. Intervention feasibility will be assessed by measures of implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events. Initial efficacy will be assessed via change in weekly steps measured via a pedometer from baseline to 6-months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| American Heart Association | Active comparator | Behavioral: Community-based social networking interventionParticipants will receive handouts on increasing physical activity derived from the American Heart Association materials on increasing physical activity. |
| Dog Walking | Experimental | Behavioral: Community-based social networking interventionThe 6-month dog walking intervention involves 5 components to address the individual, interpersonal and community levels of the socio-ecological model: newsletters, pedometers, social networking website, neighborhood dog walks, and invitations to community events. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will own a dog that is in good health and considered a household pet, be a Worcester or Lowell resident, be aged > 21 years old and have home internet access. Participants with cardiovascular disease, diabetes or other chronic health condition are eligible with permission from their PCP to participate.
Key exclusion criteria (10 listed)
- Inability or unwillingness to give informed consent
- Plans to move out of the area within the study period
- Participated in a focus group during the developmental phase
- Another household member is participating in the study
- Pregnant or planning a pregnancy in the next six months
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 |
|---|---|---|
| Community-based social networking interventionParticipation in this study lasts for 7 months and includes a baseline visit, an orientation visit, the 6 month intervention, and a 6 month assessment visit. | Behavioural | American Heart Association, Dog Walking |
Primary outcome
feasibility
Time frame: 6 months
Feasibility will be assessed by implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events.
4 secondary outcomes
Weekly steps
Time frame: baseline and 6 months
weekly dog walking minutes
Time frame: baseline and 6 months
social support for walking
Time frame: baseline and 6 months
sense of community
Time frame: baseline and 6 months
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 15 Apr 2013.
- Derived from this study: PubMed 25003777Schneider KL, Murphy D, Ferrara C, Oleski J, Panza E, Savage C, Gada K, Bozzella B, Olendzki E, Kern D, Lemon SC. An online social network to increase walking in dog owners: a randomized trial. Med Sci Sports Exerc. 2015 Mar;47(3):631-9. doi: 10.1249/MSS.0000000000000441.
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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.
Krisitin Schneider, Ph.D. principal investigator
Rosalind Franklin Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Community-based social networking intervention in people with Sedentary, run by University of Massachusetts, Worcester at 2 sites 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 1 inclusion and 10 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 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
feasibility (time frame: 6 months). 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 NCT01593449, 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 15 Apr 2013.