PlayFit Pilot: Encouraging Social Physical Play in the Community
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PlayFit - modified exercise games
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Age 21-50
- Fluently read and speak English
- Current member of Hershey Medical Center's University Fitness Center OR willing to become a member
- Currently exercises < 150 minutes per week
Exclusion Criteria:
- Has been told by a doctor they a heart condition and should only do exercise recommended by a doctor
- Currently pregnant or planning to become pregnant in the next 6 months
- Planning to move out of the area in the next 6 months
- Has pain in chest, neck, jaw, or arms at rest, during daily activities of living
- Has experienced a forceful or rapid heart rate
- Has experience unreasonable breathlessness
- Has experienced dizziness fainting or blackouts
- Has experienced ankle swelling
- Has burning or cramping sensation in lower legs when walking short distances
- Has been told by a health professional not to exercise OR exercise only when supervised by a professional
- Has been diagnosed with diabetes
- Has been told by a doctor, nurse or health professional that they have (1) Weak or failing kidneys, (2) A heart attack/ myocardial infarction, (3) Angina or coronary heart disease, (4) A stroke, or (5) Any other kind of heart condition or heart disease - e.g. heart valve problem/aortic regurgitation (do not include heart murmur)
Sites / Locations
- Penn State Hershey Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PlayFit, Modified exercise games
Arm Description
Subjects will participate in three 60 minute game sessions each week for 12 weeks. During each game session, subjects will be divided randomly into two teams to play a modified game. Research staff will review the instructions of the game and if needed, modify the game rules during play to enhance the experience (ie. keep it fun, keep it to moderate intensity level). The length of play session between breaks increases each week.
Outcomes
Primary Outcome Measures
Compare exercise intensity, METS (Metabolic Equivalent Task)
METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).
Secondary Outcome Measures
Self-reported weight
Self-reported weight will be captured by a research assistant at baseline and follow up (12 week) visits.
Self-reported height
Self-reported height will be captured by a research assistant at baseline and follow up (12 week) visits.
Gender
Participants will be asked if they are male or female.
Self-reported chronic conditions
Participants will be asked 4 questions on which chronic conditions (if any) they may have.
Ethnicity
Participants will be asked what their ethnicity is.
Race
Participants will be asked what their race is.
Education Level
Participants will be asked 1 question on education level.
Employment Status
Participants will be asked 1 question on employment status.
Tobacco Use
Participants will be asked 1 question on tobacco use.
National Health Interview Survey
Participants will be asked 2 questions from this survey on how difficult it is to walk and carry an item.
General Self Rated Health
Participants will be asked 1 question on their overall health.
Three Item Loneliness Scale
Participants will be asked 3 questions on feelings of being lonely.
Patient Reported Outcomes (PROMIS) - Anxiety
Participants will be asked questions 4 questions on anxiety.
Patient Reported Outcomes (PROMIS) - Depression
Participants will be asked 4 questions on Depression.
Patient Reported Outcomes (PROMIS) - Physical Function
Participants will be asked 4 questions on physical function.
Sport playing status
Participants will be asked 2 questions on playing sports previously.
Program Intensity Survey
Participants will be asked 2 questions after each game session on how physically and technically hard the game was.
Program Satisfaction Survey
Participants will be asked 2 questions after each game session on what they did and did not like about the game.
Net Promoter Score
Participants will be asked 1 question on how likely they would recommend the day's activity/game to a friend or family member.
Full Information
NCT ID
NCT02944370
First Posted
October 17, 2016
Last Updated
December 6, 2016
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02944370
Brief Title
PlayFit Pilot: Encouraging Social Physical Play in the Community
Official Title
PlayFit Pilot: Encouraging Social Physical Play in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator is pilot testing the feasibility and impact of a low-cost intervention that uses existing gymnasiums, and therefore has the potential to be replicated across the United States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key components, intended to overcome the major barriers to physical activity. First, it will assist people in finding others to play with, using the Pick-Up model of designating times to play and making those times known in the community. Second, it will overcome a lack of confidence in physical activity by including games of lower intensity for relatively unfit adults, then building up to moderate and vigorous games. Third, it will require team members of varying ages and genders to encourage intergenerational play. Fourth, it will use modified equipment (e.g., softer, lighter balls) and smaller game space to require less running, so that even relatively unfit people can feel confident participating. Fifth, it will be designed to be led by community volunteers, which will increase its disseminability.
AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will come up with a list of games to play and pilot the games at a gymnasium. The investigators will observe the participants playing the games and have them complete a brief survey.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PlayFit, Modified exercise games
Arm Type
Experimental
Arm Description
Subjects will participate in three 60 minute game sessions each week for 12 weeks. During each game session, subjects will be divided randomly into two teams to play a modified game. Research staff will review the instructions of the game and if needed, modify the game rules during play to enhance the experience (ie. keep it fun, keep it to moderate intensity level). The length of play session between breaks increases each week.
Intervention Type
Behavioral
Intervention Name(s)
PlayFit - modified exercise games
Intervention Description
Play modified games with other adults three times a week for 12 weeks. Complete a brief survey on the games played and program satisfaction.
Primary Outcome Measure Information:
Title
Compare exercise intensity, METS (Metabolic Equivalent Task)
Description
METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-reported weight
Description
Self-reported weight will be captured by a research assistant at baseline and follow up (12 week) visits.
Time Frame
12 weeks
Title
Self-reported height
Description
Self-reported height will be captured by a research assistant at baseline and follow up (12 week) visits.
Time Frame
12 weeks
Title
Gender
Description
Participants will be asked if they are male or female.
Time Frame
12 weeks
Title
Self-reported chronic conditions
Description
Participants will be asked 4 questions on which chronic conditions (if any) they may have.
Time Frame
12 weeks
Title
Ethnicity
Description
Participants will be asked what their ethnicity is.
Time Frame
12 weeks
Title
Race
Description
Participants will be asked what their race is.
Time Frame
12 weeks
Title
Education Level
Description
Participants will be asked 1 question on education level.
Time Frame
12 weeks
Title
Employment Status
Description
Participants will be asked 1 question on employment status.
Time Frame
12 weeks
Title
Tobacco Use
Description
Participants will be asked 1 question on tobacco use.
Time Frame
12 weeks
Title
National Health Interview Survey
Description
Participants will be asked 2 questions from this survey on how difficult it is to walk and carry an item.
Time Frame
12 weeks
Title
General Self Rated Health
Description
Participants will be asked 1 question on their overall health.
Time Frame
12 weeks
Title
Three Item Loneliness Scale
Description
Participants will be asked 3 questions on feelings of being lonely.
Time Frame
12 weeks
Title
Patient Reported Outcomes (PROMIS) - Anxiety
Description
Participants will be asked questions 4 questions on anxiety.
Time Frame
12 weeks
Title
Patient Reported Outcomes (PROMIS) - Depression
Description
Participants will be asked 4 questions on Depression.
Time Frame
12 weeks
Title
Patient Reported Outcomes (PROMIS) - Physical Function
Description
Participants will be asked 4 questions on physical function.
Time Frame
12 weeks
Title
Sport playing status
Description
Participants will be asked 2 questions on playing sports previously.
Time Frame
12 weeks
Title
Program Intensity Survey
Description
Participants will be asked 2 questions after each game session on how physically and technically hard the game was.
Time Frame
12 weeks
Title
Program Satisfaction Survey
Description
Participants will be asked 2 questions after each game session on what they did and did not like about the game.
Time Frame
12 weeks
Title
Net Promoter Score
Description
Participants will be asked 1 question on how likely they would recommend the day's activity/game to a friend or family member.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 21-50
Fluently read and speak English
Current member of Hershey Medical Center's University Fitness Center OR willing to become a member
Currently exercises < 150 minutes per week
Exclusion Criteria:
Has been told by a doctor they a heart condition and should only do exercise recommended by a doctor
Currently pregnant or planning to become pregnant in the next 6 months
Planning to move out of the area in the next 6 months
Has pain in chest, neck, jaw, or arms at rest, during daily activities of living
Has experienced a forceful or rapid heart rate
Has experience unreasonable breathlessness
Has experienced dizziness fainting or blackouts
Has experienced ankle swelling
Has burning or cramping sensation in lower legs when walking short distances
Has been told by a health professional not to exercise OR exercise only when supervised by a professional
Has been diagnosed with diabetes
Has been told by a doctor, nurse or health professional that they have (1) Weak or failing kidneys, (2) A heart attack/ myocardial infarction, (3) Angina or coronary heart disease, (4) A stroke, or (5) Any other kind of heart condition or heart disease - e.g. heart valve problem/aortic regurgitation (do not include heart murmur)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sciamanna, MD, MPH
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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PlayFit Pilot: Encouraging Social Physical Play in the Community
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