An interventional study of Soccer-based adaptation to the DPP in Diabetes, sponsored by Emory University. Completed at 1 site in United States. Open to male participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Hispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention.
Behavioral: Soccer-based adaptation to the DPP
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.
Number of Participants Completing the Study
Feasibility of the study will be assessed by the number of participants completing the study.
Time frame: 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).
Time frame: Week 24
Weight
Body composition will be assessed by weight in kilograms (kg).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 12, Week 24
Waist Circumference
Body composition will be assessed by waist circumference measured in centimeters (cm).
Time frame: Baseline, Week 12, Week 24
Participants were recruited in April through July of 2018 and all follow-up was completed by December 16, 2018.
| Milestone | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Started | 41 |
| Completed week 12 assessment | 37 |
| Completed | 25 |
| Not completed | 16 |
| Withdrew: Other time commitments | 8 |
| Withdrew: Changes to session time | 7 |
| Withdrew: Relocation out of country | 1 |
Feasibility of the study will be assessed by the number of participants completing the study.
| Participants | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Number of Participants Completing the Study | 25 |
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).
| units on a scale | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Participant Satisfaction With Overall Program | 9.9 ± 0.3 |
Body composition will be assessed by weight in kilograms (kg).
| kilograms | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 93.9 ± 2.2 |
| Week 12 | 90.7 ± 2.0 |
| Week 24 | 90.1 ± 2.0 |
Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per day.
| Steps per day | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 12644.5 ± 769 |
| Week 12 | 11131.9 ± 807.7 |
| Week 24 | 9691.2 ± 993.6 |
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.
| grams | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 29.9 ± 3.5 |
| Week 12 | 32.2 ± 4.0 |
| Week 24 | 29.8 ± 4.4 |
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.
| servings of fruit | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 2.2 ± 0.3 |
| Week 12 | 2.3 ± 0.5 |
| Week 24 | 1.7 ± 0.3 |
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.
| servings of vegetables | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 3.2 ± 0.3 |
| Week 12 | 3.7 ± 0.4 |
| Week 24 | 3.1 ± 0.3 |
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.
| MET minutes per week | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 2872.5 ± 613.8 |
| Week 12 | 4716.7 ± 683.4 |
| Week 24 | 5952.6 ± 1236.9 |
Body composition will be assessed by waist circumference measured in centimeters (cm).
| centimeters | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Baseline | 107.7 ± 1.6 |
| Week 12 | 103.3 ± 1.5 |
| Week 24 | 101.1 ± 1.5 |
Collected over Information about adverse events was collected from the time participants began the intervention through the end of intervention assessment at Week 24.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Soccer-based Adaptation to the Diabetes Prevention Program (DPP) | 0/41 (0%) | 0/41 (0%) | 5/41 (12.2%) |
| Event | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Mild injuriesMusculoskeletal and connective tissue disorders | 5/41 |
| Age, Continuous(years) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Mean | 41.9 ± 6.2 |
| Sex: Female, Male(Participants) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Female | 0 |
| Male | 41 |
| Ethnicity (NIH/OMB)(Participants) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Hispanic or Latino | 41 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| United States | 41 |
| Family history of diabetes(Participants) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Count of participants | 21 |
| Country of origin(Participants) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Mexico | 16 |
| Venezuela | 4 |
| Ecuador | 3 |
| Guatemala | 4 |
| Colombia | 7 |
| Other | 7 |
| Body Mass Index (BMI)(kg/m²) | Soccer-based Adaptation to the Diabetes Prevention Program (DPP) |
|---|---|
| Mean | 32.7 ± 0.7 |
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Plan to share: Yes — Deidentified individual participant data supporting the conclusions of this study are available for sharing with other researchers.
Time frame: Raw data are available for sharing following publication of the results of this study.
Access criteria: Access to the data can be obtained by emailing the study investigators.
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