PlayFit Pilot: Encouraging Social Physical Play in the Community

Overweight and Obesity Clinical Trial

Official title:

PlayFit Pilot: Encouraging Social Physical Play in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944370
• Other study ID #: 4785
• Status: Completed
• Phase: N/A
• First received: October 17, 2016
• Last updated: December 6, 2016
• Start date: August 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• PlayFit - modified exercise games
Play modified games with other adults three times a week for 12 weeks. Complete a brief survey on the games played and program satisfaction.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare exercise intensity, METS (Metabolic Equivalent Task)	METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).	12 weeks	No
Secondary	Self-reported weight	Self-reported weight will be captured by a research assistant at baseline and follow up (12 week) visits.	12 weeks	No
Secondary	Self-reported height	Self-reported height will be captured by a research assistant at baseline and follow up (12 week) visits.	12 weeks	No
Secondary	Gender	Participants will be asked if they are male or female.	12 weeks	No
Secondary	Self-reported chronic conditions	Participants will be asked 4 questions on which chronic conditions (if any) they may have.	12 weeks	No
Secondary	Ethnicity	Participants will be asked what their ethnicity is.	12 weeks	No
Secondary	Race	Participants will be asked what their race is.	12 weeks	No
Secondary	Education Level	Participants will be asked 1 question on education level.	12 weeks	No
Secondary	Employment Status	Participants will be asked 1 question on employment status.	12 weeks	No
Secondary	Tobacco Use	Participants will be asked 1 question on tobacco use.	12 weeks	No
Secondary	National Health Interview Survey	Participants will be asked 2 questions from this survey on how difficult it is to walk and carry an item.	12 weeks	No
Secondary	General Self Rated Health	Participants will be asked 1 question on their overall health.	12 weeks	No
Secondary	Three Item Loneliness Scale	Participants will be asked 3 questions on feelings of being lonely.	12 weeks	No
Secondary	Patient Reported Outcomes (PROMIS) - Anxiety	Participants will be asked questions 4 questions on anxiety.	12 weeks	No
Secondary	Patient Reported Outcomes (PROMIS) - Depression	Participants will be asked 4 questions on Depression.	12 weeks	No
Secondary	Patient Reported Outcomes (PROMIS) - Physical Function	Participants will be asked 4 questions on physical function.	12 weeks	No
Secondary	Sport playing status	Participants will be asked 2 questions on playing sports previously.	12 weeks	No
Secondary	Program Intensity Survey	Participants will be asked 2 questions after each game session on how physically and technically hard the game was.	12 weeks	No
Secondary	Program Satisfaction Survey	Participants will be asked 2 questions after each game session on what they did and did not like about the game.	12 weeks	No
Secondary	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.	12 weeks	No