DiabetesNCT03595384
Soccer-based Adaptation of the Diabetes Prevention Program
A study testing Soccer-based adaptation to the DPP in people with Diabetes, run by Emory University at 1 site in United States.
Trial summary
This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program (DPP) and preliminary changes in physical activity and diet-related measures. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Soccer-based adaptation to the DPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2018to 16 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hispanic/Latino men aged 35-55 years
- Body Mass Index (BMI) ≥ 25 kg/m^2
- Centers for Disease Control and Prevention (CDC) pre-diabetes risk score ≥ 9
- Not currently engaged in soccer practice or league or other physical activity or lifestyle intervention program
- Ability to read in English or Spanish and provide inform consent
Who cannot join
- T2DM diagnosis or medication
- BMI ≥ 41
- Resting blood pressure ≥165/100 at screening
- Any mobility issues or contraindications for high intensity interval training (HIIT) physical activity program
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
Official title: Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program
This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program (DPP) and preliminary changes in physical activity and diet-related measures. Overweight participants at high risk for type 2 diabetes mellitus (T2DM) will be recruited through soccer interest groups, local leagues and Hispanic health organizations. After a baseline assessment visit, participants will attend soccer practice twice a week for 12 weeks while completing the National Diabetes Prevention Program (NDPP) core curriculum online modules with facilitated discussion by trained coaches during each soccer practice. Participants will then be invited to join an established small-sided soccer league in their community (for 12 weeks) offering one game per week and will also complete the NDPP maintenance modules and physical activity and diet self-tracking via mobile health technologies. After the core (first 12 weeks) and maintenance intervention periods (second 12 weeks) baseline measurements will be repeated. Data on the feasibility of this DPP soccer-based adaptation will inform future randomized, controlled trials testing the effectiveness of this translation model to reduce T2DM risk while extrapolating to other sports-based adaptation and age, gender and racial sub-populations.
Read the detailed description
The Diabetes Prevention Program (DPP) has been successful in reducing the incidence of type 2 diabetes mellitus (T2DM) through moderate weight loss and increased physical activity, and evidence from the original DPP suggests that adoption of increased physical activity (PA) habits are maintained up to 10 years among intervention participants when compared to control. Hispanic males are difficult to engage in traditional lifestyle or non-communicable chronic disease (NCDs) prevention interventions, yet, they have high rates of obesity and are at high risk for NCDs, particularly T2DM. Small-sided recreational soccer (RS) 6-12 month interventions have shown to be effective to achieve 5% weight loss and reduce cardio-metabolic risk, stemming from its varied movement patterns and highly functional training. Although proven cost-effectiveness and currently expanding in Europe, RS cardio-metabolic preventive interventions have not been tested in U.S. populations.
To fill this gap in health promotion, the goal for this proposal is to utilize the local Hispanic community's interest in soccer as a vehicle to deliver an adapted DPP among male, overweight, Latino adults at high T2DM risk. The researchers will test the following central hypothesis: A soccer-based adaptation to the DPP, can be feasibly implemented in a middle-age Latino men population at high risk for T2DM. In lieu of the traditional walking or exercise program, participants will be enrolled in 12 weeks of soccer conditioning followed by 12 weeks of small-sided soccer league play. National Diabetes Prevention Program (NDPP) online core and maintenance modules will also be facilitated by trained coaches during soccer practice for the first 12 weeks and through monthly in-person meetings the last 12 weeks. Physical activity volume, sleep and sedentary time will be tracked objectively with wearable devices linked to an innovative research smartphone app that provides data to the researchers and tailored in-app notifications and surveys to the participant. Additionally, the study will assess implementation feasibility and explore preliminary signals for improvements in objectively-measured PA, dietary behaviors, physical fitness and body composition and quality of life outcomes with the soccer-based DPP adaptation.
- Conditions
- Diabetes
- Being tested
- Soccer-based adaptation to the DPP
- Keywords
- Behavioral intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soccer-based adaptation to the DPPBehavioural
Participants will complete online education modules during an initial 12 week conditioning phase where they will participate in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants will transition onto a soccer league team for the following 12 weeks where they will continue to complete online modules and meet with the soccer coach monthly.
During the soccer sessions and games participants will be fitted with a wearable soccer-specific device to measure how much they move and their heart rate. In addition, they will also be asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
The online education will be a version of the Diabetes Prevention Program and can be completed on a phone or computer with internet access.
| Study group | Role | What they receive |
|---|---|---|
| Soccer-based adaptation to the DPP | Experimental | Hispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention. Receives: Behavioral: Soccer-based adaptation to the DPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing the Study
Feasibility of the study will be assessed by the number of participants completing the study.
Measured: Week 24
Participant Satisfaction With Overall Program
Participants indicate how satisfied they were with the overall program with a single item which was scored on a scale of 1 (poor) to 10 (excellent).
Measured: Week 24
Secondary outcomes (7)
Weight
Body composition will be assessed by weight in kilograms (kg).
Measured: Baseline, Week 12, Week 24
Steps Per Day
Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per day.
Measured: Baseline, Week 12, Week 24
Intake of Added Sugars
The dietary behavior of consumption of added sugars was measured by using the Nutrition Database System for Research (NDSR) 24-hour dietary recall. The NDSR is a dietary analysis software application used to collect and calculate nutritional intake.
Measured: Baseline, Week 12, Week 24
Intake of Fruit
The dietary behavior of consumption of fruit was measured by using the NDSR 24-hour dietary recall. The NDSR is a dietary analysis software application used to collect and calculate nutritional intake. The NDSR calculates the number of servings from 7 subcategories including citrus fruits, fruits other than citrus, avocado, as well as processed fruits. Serving amounts for all fruit are calculated by the NDSR software based on standard serving sizes for each specific food item. The total servings from all subcategories are reported here.
Measured: Baseline, Week 12, Week 24
Intake of Vegetables
The dietary behavior of consumption of vegetables was measured by using the NDSR 24-hour dietary recall. The NDSR is a dietary analysis software application used to collect and calculate nutritional intake. The NDSR calculates the number of servings from 10 subcategories including potatoes, juice, green or yellow vegetables, and legumes. Serving amounts for all fruit are calculated by the NDSR software based on standard serving sizes for each specific food item. The total servings from all subcategories are reported here.
Measured: Baseline, Week 12, Week 24
Change in International Physical Activity Questionnaire (IPAQ) Score
The International Physical Activity Questionnaire (IPAQ) includes 7-items asking respondents how many days in the past week they participated in vigorous, moderate and mild activities and how many minutes per day they spent on those activities. Data collected with IPAQ can be reported as a continuous measure and is computed by weighting each type of activity by its energy requirements defined in Metabolic Equivalent of Tasks (METs) to yield a score in MET-minutes (the MET score of an activity multiplied by the minutes performed). MET-minutes per week will be compared between study time points.
Measured: Baseline, Week 12, Week 24
Waist Circumference
Body composition will be assessed by waist circumference measured in centimeters (cm).
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start29 Apr 2018
- Primary completion16 Dec 2018
- Study completion16 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program and preliminary changes in physical activity and diet-related measures.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Southern Denmark
- Responsible party
- Principal investigator, Roberto Felipe Lobelo, Emory University
- Investigators
- Felipe Lobelo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595384
- Sponsor's protocol ID
- IRB00100342
- Other IDs
- P30DK111024
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2018
- Last updated
- 12 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data supporting the conclusions of this study are available for sharing with other researchers.
Publications
Frediani JK, Bienvenida AF, Li J, Higgins MK, Lobelo F. Physical fitness and activity changes after a 24-week soccer-based adaptation of the U.S diabetes prevention program intervention in Hispanic men. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):775-785. doi: 10.1016/j.pcad.2020.06.012. Epub 2020 Jun 27.
PubMed 32603753Frediani JK, Li J, Bienvenida A, Higgins MK, Lobelo F. Metabolic Changes After a 24-Week Soccer-Based Adaptation of the Diabetes Prevention Program in Hispanic Males: A One-Arm Pilot Clinical Trial. Front Sports Act Living. 2021 Nov 12;3:757815. doi: 10.3389/fspor.2021.757815. eCollection 2021.
PubMed 34870194
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT03595384
- Acronym / sponsor ID
- IRB00100342
- Conditions
- Diabetes
- Keywords
- Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Southern Denmark
- Study start
- 29 Apr 2018 (actual)
- Primary completion
- 16 Dec 2018 (actual)
- Study completion
- 16 Dec 2018 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program (DPP) and preliminary changes in physical activity and diet-related measures. Overweight participants at high risk for type 2 diabetes mellitus (T2DM) will be recruited through soccer interest groups, local leagues and Hispanic health organizations. After a baseline assessment visit, participants will attend soccer practice twice a week for 12 weeks while completing the National Diabetes Prevention Program (NDPP) core curriculum online modules with facilitated discussion by trained coaches during each soccer practice. Participants will then be invited to join an established small-sided soccer league in their community (for 12 weeks) offering one game per week and will also complete the NDPP maintenance modules and physical activity and diet self-tracking via mobile health technologies. After the core (first 12 weeks) and maintenance intervention periods (second 12 weeks) baseline measurements will be repeated. Data on the feasibility of this DPP soccer-based adaptation will inform future randomized, controlled trials testing the effectiveness of this translation model to reduce T2DM risk while extrapolating to other sports-based adaptation and age, gender and racial sub-populations.
Detailed description
The Diabetes Prevention Program (DPP) has been successful in reducing the incidence of type 2 diabetes mellitus (T2DM) through moderate weight loss and increased physical activity, and evidence from the original DPP suggests that adoption of increased physical activity (PA) habits are maintained up to 10 years among intervention participants when compared to control. Hispanic males are difficult to engage in traditional lifestyle or non-communicable chronic disease (NCDs) prevention interventions, yet, they have high rates of obesity and are at high risk for NCDs, particularly T2DM. Small-sided recreational soccer (RS) 6-12 month interventions have shown to be effective to achieve 5% weight loss and reduce cardio-metabolic risk, stemming from its varied movement patterns and highly functional training. Although proven cost-effectiveness and currently expanding in Europe, RS cardio-metabolic preventive interventions have not been tested in U.S. populations.
To fill this gap in health promotion, the goal for this proposal is to utilize the local Hispanic community's interest in soccer as a vehicle to deliver an adapted DPP among male, overweight, Latino adults at high T2DM risk. The researchers will test the following central hypothesis: A soccer-based adaptation to the DPP, can be feasibly implemented in a middle-age Latino men population at high risk for T2DM. In lieu of the traditional walking or exercise program, participants will be enrolled in 12 weeks of soccer conditioning followed by 12 weeks of small-sided soccer league play. National Diabetes Prevention Program (NDPP) online core and maintenance modules will also be facilitated by trained coaches during soccer practice for the first 12 weeks and through monthly in-person meetings the last 12 weeks. Physical activity volume, sleep and sedentary time will be tracked objectively with wearable devices linked to an innovative research smartphone app that provides data to the researchers and tailored in-app notifications and surveys to the participant. Additionally, the study will assess implementation feasibility and explore preliminary signals for improvements in objectively-measured PA, dietary behaviors, physical fitness and body composition and quality of life outcomes with the soccer-based DPP adaptation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program and preliminary changes in physical activity and diet-related measures.
| Arm | Type | Receives |
|---|---|---|
| Soccer-based adaptation to the DPP | Experimental | Behavioral: Soccer-based adaptation to the DPPHispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hispanic/Latino men aged 35-55 years
- Body Mass Index (BMI) ≥ 25 kg/m^2
- Centers for Disease Control and Prevention (CDC) pre-diabetes risk score ≥ 9
- Not currently engaged in soccer practice or league or other physical activity or lifestyle intervention program
- Ability to read in English or Spanish and provide inform consent
Key exclusion criteria (4 listed)
- T2DM diagnosis or medication
- BMI ≥ 41
- Resting blood pressure ≥165/100 at screening
- Any mobility issues or contraindications for high intensity interval training (HIIT) physical activity program
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 |
|---|---|---|
| Soccer-based adaptation to the DPPParticipants will complete online education modules during an initial 12 week conditioning phase where they will participate in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants will transition onto a soccer league team for the following 12 weeks where they will continue to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants will be fitted with a wearable soccer-specific device to measure how much they move and their heart rate. In addition, they will also be asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity. The online education will be a version of the Diabetes Prevention Program and can be completed on a phone or computer with internet access. | Behavioural | Soccer-based adaptation to the DPP |
Primary outcome
Number of Participants Completing the Study
Time frame: Week 24
Feasibility of the study will be assessed by the number of participants completing the study.
Participant Satisfaction With Overall Program
Time frame: Week 24
Participants indicate how satisfied they were with the overall program with a single item which was scored on a scale of 1 (poor) to 10 (excellent).
7 secondary outcomes
Weight
Time frame: Baseline, Week 12, Week 24
Steps Per Day
Time frame: Baseline, Week 12, Week 24
Intake of Added Sugars
Time frame: Baseline, Week 12, Week 24
Intake of Fruit
Time frame: Baseline, Week 12, Week 24
Intake of Vegetables
Time frame: Baseline, Week 12, Week 24
Change in International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Week 12, Week 24
Waist Circumference
Time frame: Baseline, Week 12, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32603753Frediani JK, Bienvenida AF, Li J, Higgins MK, Lobelo F. Physical fitness and activity changes after a 24-week soccer-based adaptation of the U.S diabetes prevention program intervention in Hispanic men. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):775-785. doi: 10.1016/j.pcad.2020.06.012. Epub 2020 Jun 27.
- Results publication: PubMed 34870194Frediani JK, Li J, Bienvenida A, Higgins MK, Lobelo F. Metabolic Changes After a 24-Week Soccer-Based Adaptation of the Diabetes Prevention Program in Hispanic Males: A One-Arm Pilot Clinical Trial. Front Sports Act Living. 2021 Nov 12;3:757815. doi: 10.3389/fspor.2021.757815. eCollection 2021.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data supporting the conclusions of this study are available for sharing with other researchers.
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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.
Felipe Lobelo, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer-based adaptation to the DPP in people with Diabetes, run by Emory University 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 5 inclusion and 4 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 12 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Completing the Study (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595384, which also lists 2 linked publications.
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 12 Aug 2022.