NCT02944370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

October 17, 2016

Last Update Submit

December 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare exercise intensity, METS (Metabolic Equivalent Task)

    METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).

    12 weeks

Secondary Outcomes (19)

  • Self-reported weight

    12 weeks

  • Self-reported height

    12 weeks

  • Gender

    12 weeks

  • Self-reported chronic conditions

    12 weeks

  • Ethnicity

    12 weeks

  • +14 more secondary outcomes

Study Arms (1)

PlayFit, Modified exercise games

EXPERIMENTAL

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.

Behavioral: PlayFit - modified exercise games

Interventions

Play modified games with other adults three times a week for 12 weeks. Complete a brief survey on the games played and program satisfaction.

PlayFit, Modified exercise games

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Sciamanna, MD, MPH

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Division Chief of Population Health, Research and Development

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 25, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations