Health BehaviorNCT03444129
Pilot Evaluation of an Interactive Health Game
A study testing Healthy eating workshop and interactive health game and Healthy eating workshop in people with Health Behavior and Health Attitude, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Health Behavior, Health Attitude
- What is being tested?
- Healthy eating workshop and interactive health game and Healthy eating workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2018to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Official title: 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.
- Conditions
- Health Behavior, Health Attitude
- Being tested
- Healthy eating workshop and interactive health game, Healthy eating workshop
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy eating workshop and interactive health gameBehavioural
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.
Healthy eating workshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will participate in a health education workshop with weekly sessions (control group) Receives: Behavioral: Healthy eating workshop |
| Game | Experimental | This group will participate in the health education workshop plus the interactive health game (intervention group). Receives: Behavioral: Healthy eating workshop and interactive health game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating habits
Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.
Measured: 6 weeks
Physical activity patterns
Physical activity patterns will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
Measured: 6 weeks
Motivation
Behavioral motivation questions will include Stage of change and confidence items to assess motivation (i.e., readiness) or achievement of behavioral goals.
Measured: 6 weeks
Secondary outcomes (5)
Weight
Weight will be measured using a digital scale
Measured: 6 weeks
Adherence
Adherence will be measured by a count of the sessions attended.
Measured: 6 weeks
Short International Physical Activity Questionnaire
Acceptability will be measured using this survey
Measured: 6 weeks
MPP Acceptability Survey
This survey is about the participants experiences using MyPlatePicks (MPP) game
Measured: 6 weeks
MPP stages of change survey
acceptability will be measured using this survey
Measured: 6 week s
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start20 Jan 2018
- Primary completion10 Mar 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amparo Castillo, University of Illinois Chicago
- Investigators
- Amparo Castillo, PhD, Principal investigator, UICLaurie Ruggiero, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444129
- Sponsor's protocol ID
- 2016-0218
- Other IDs
- 5P30AG022849
- Status last verified
- Feb 2018
- First submitted
- 15 Nov 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of an Interactive Health Game Designed to Promote Healthy Eating and Physical Activity on Older Adults.
- ClinicalTrials.gov ID
- NCT03444129
- Acronym / sponsor ID
- 2016-0218
- Conditions
- Health Behavior, Health Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Healthy eating workshopThis group will participate in a health education workshop with weekly sessions (control group) |
| Game | Experimental | Behavioral: Healthy eating workshop and interactive health gameThis group will participate in the health education workshop plus the interactive health game (intervention group). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy eating workshop and interactive health gameThe 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. | Behavioural | Game |
| Healthy eating workshopThe 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. | Behavioural | Control |
Primary outcome
Eating habits
Time frame: 6 weeks
Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.
Physical activity patterns
Time frame: 6 weeks
Physical activity patterns will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
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.
5 secondary outcomes
Weight
Time frame: 6 weeks
Adherence
Time frame: 6 weeks
Short International Physical Activity Questionnaire
Time frame: 6 weeks
MPP Acceptability Survey
Time frame: 6 weeks
MPP stages of change survey
Time frame: 6 week s
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amparo Castillo, PhD principal investigator
UIC
Laurie Ruggiero, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy eating workshop and interactive health game and Healthy eating workshop in people with Health Behavior and Health Attitude, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating habits (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.