- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444129
Pilot Evaluation of an Interactive Health Game
April 14, 2020 updated by: Amparo Castillo, University of Illinois at Chicago
Pilot Evaluation of an Interactive Health Game Designed to Promote Healthy Eating and Physical Activity on Older Adults.
Broad, diverse, and innovative efforts are needed to address the growing dual public health challenges of obesity and diabetes, especially for those at increased risk like minority older adults.
The emerging field of health games offers an innovative opportunity to reach populations to provide healthy eating and physical activity messages.
Little research has focused on the use of health games specifically tailored for older adults.
This study builds upon a health game designed to provide knowledge, facilitate movement, enhance motivation, and encourage healthy eating (HE) and physical activity (PA) behaviors in youth.
This study will adapt, implement, and evaluate the feasibility, acceptability, adherence, and preliminary outcomes of the game among overweight/obese African American older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- University of Illinois at Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 50 and 65 years
- Overweight or obese (25kg/m2 ≤ BMI < 40kg/m2)
- African American/Black by self-report
- Risk factors for diabetes (based on adapted ADA risk test)
Exclusion Criteria:
- Adults with cognitive impairments, based on the adapted Mental Status Questionnaire (MSQ).
- Health conditions that preclude participation in physical activity program, based on the Exercise Assessment and Screener for You (EASY) physical activity screener.
- Already diagnosed with diabetes by self-report
- Currently engaging in vigorous physical activity
- Non-English speaking
- Does not meet inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
This group will participate in a health education workshop with weekly sessions (control group)
|
The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop.
Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.
|
|
Experimental: Game
This group will participate in the health education workshop plus the interactive health game (intervention group).
|
The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop and interactive health game.
Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating habits
Time Frame: 6 weeks
|
Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.
|
6 weeks
|
|
Physical activity patterns
Time Frame: 6 weeks
|
Physical activity patterns will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
|
6 weeks
|
|
Motivation
Time Frame: 6 weeks
|
Behavioral motivation questions will include Stage of change and confidence items to assess motivation (i.e., readiness) or achievement of behavioral goals.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 6 weeks
|
Weight will be measured using a digital scale
|
6 weeks
|
|
Adherence
Time Frame: 6 weeks
|
Adherence will be measured by a count of the sessions attended.
|
6 weeks
|
|
Short International Physical Activity Questionnaire
Time Frame: 6 weeks
|
Acceptability will be measured using this survey
|
6 weeks
|
|
MPP Acceptability Survey
Time Frame: 6 weeks
|
This survey is about the participants experiences using MyPlatePicks (MPP) game
|
6 weeks
|
|
MPP stages of change survey
Time Frame: 6 week s
|
acceptability will be measured using this survey
|
6 week s
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amparo Castillo, PhD, UIC
- Principal Investigator: Laurie Ruggiero, PhD, University of Delaware
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2018
Primary Completion (Actual)
March 10, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
April 16, 2020
Last Update Submitted That Met QC Criteria
April 14, 2020
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2016-0218
- 5P30AG022849 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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