STEP AND GO: A Study of Technology-based Exercise Promotion

NCT01953224 | Completed Results

• 1 other identifier: 13-0285
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults.

Conditions

Cardiovascular Disease; Obesity; Cancer; Diabetes

Keywords

Physical activity; Video game; Mobile; Technology; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity From Baseline to 12 Weeks

  Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.

  Baseline to 12 weeks

Secondary Outcomes (5)

• Change in Physical Fitness From Baseline to 12 Weeks

  Baseline to 12 weeks

• Change in Body Fat Percentage From Baseline to 12 Weeks

  Baseline to 12 weeks

• Change in Blood Pressure From Baseline to 12 Weeks

  Baseline to 12 weeks

• Change in Weight From Baseline to 12 Weeks

  Baseline to 12 weeks

• Change in Motivation From Baseline to 12 Weeks

  Baseline to 12 weeks

Other Outcomes (5)

• Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks

  12 weeks

• Acceptability

  12 weeks

• Frequency of App Use Over 12 Weeks

  12 weeks

Study Arms (2)

Game-based intervention

EXPERIMENTAL

This arm will receive the game intervention, which will include provision of a mobile smartphone device, cellular data service, the game application loaded onto the device, credit to load approximately 40-50 songs onto the device, headphones, and an armband for wearing the device. Participants will also receive weekly counseling calls.

Behavioral: Game-based intervention; Device: Smartphone

Wait list control

NO INTERVENTION

This group will receive no intervention until after completion of the final assessment of the randomized trial. Then, they will receive the full intervention.

Interventions

Game-based intervention BEHAVIORAL

Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, "Zombies, Run!" encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic "zombie chases" encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback.

Also known as: Zombies, Run!

Game-based intervention

Smartphone DEVICE

Game-based intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 69 years old
• BMI is between 25 kg/m2 and 35 kg/m2
• Able to read and understand English
• Able to read words in standard applications on a mobile device 5" large
• Able to walk for exercise
• Able to find transportation to the study location
• Willing to use a smartphone provided by the study to participate
• Willing to listen to a potentially scary or sad story that includes violence
• Willing to share basic information on walks with other participants via a social network

You may not qualify if:

• (If female) currently pregnant or nursing or plan to become pregnant in the next 6 months
• Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4). Reporting taking medicine for blood pressure on this questionnaire will require a doctor's note to participate.
• Unable to walk for exercise (self-report)
• Report current symptoms of alcohol or substance dependence
• Plans to move away from the Galveston-Houston area in the next 4 months or to be out of town for more than 1 week during the study period
• Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
• Takes medications for diabetes or thyroid issues
• Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
• Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
• Another member of the household is a participant or staff member on this trial
• Currently a participant in a physical activity or weight loss research trial
• Recently (less than six months ago) completed a physical activity or weight loss research trial
• Recently (less than six months ago) lost more than 5% of their body weight
• Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis - may be eligible, but a doctor's note will be required)
• Current smoker

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• American Heart Association: collaborator

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Neoplasms; Diabetes Mellitus; Motor Activity

Interventions

Jogging

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Running; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Limitations and Caveats

This was a pilot/feasibility study. Sample sizes for the maximal fitness tests and blood pressure were low due to difficulties with feasibility for those measures. Analyses used the intent to treat principle.

Results Point of Contact

• Title: Eloisa Martinez
• Organization: The University of Texas Medical Branch

esmartin@utmb.edu

4092669643

Study Officials

• Elizabeth J Lyons, PhD, MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 30, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-04

Locations

US (1)