Trial Outcomes & Findings for Soccer-based Adaptation of the Diabetes Prevention Program (NCT NCT03595384)
NCT ID: NCT03595384
Last Updated: 2022-08-12
Results Overview
Feasibility of the study will be assessed by the number of participants completing the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Week 24
Results posted on
2022-08-12
Participant Flow
Participants were recruited in April through July of 2018 and all follow-up was completed by December 16, 2018.
Participant milestones
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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|---|---|
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Overall Study
STARTED
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41
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Overall Study
Completed Week 12 Assessment
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37
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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16
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Reasons for withdrawal
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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|---|---|
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Overall Study
Other time commitments
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8
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Overall Study
Changes to session time
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7
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Overall Study
Relocation out of country
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1
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Baseline Characteristics
Soccer-based Adaptation of the Diabetes Prevention Program
Baseline characteristics by cohort
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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|---|---|
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Age, Continuous
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41.9 years
STANDARD_DEVIATION 6.2 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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41 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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41 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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41 Participants
n=5 Participants
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Family history of diabetes
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21 Participants
n=5 Participants
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Country of origin
Mexico
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16 Participants
n=5 Participants
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Country of origin
Venezuela
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4 Participants
n=5 Participants
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Country of origin
Ecuador
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3 Participants
n=5 Participants
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Country of origin
Guatemala
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4 Participants
n=5 Participants
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Country of origin
Colombia
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7 Participants
n=5 Participants
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Country of origin
Other
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7 Participants
n=5 Participants
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Body Mass Index (BMI)
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32.7 kg/m²
STANDARD_DEVIATION 0.7 • n=5 Participants
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PRIMARY outcome
Timeframe: Week 24Feasibility of the study will be assessed by the number of participants completing the study.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Number of Participants Completing the Study
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25 Participants
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PRIMARY outcome
Timeframe: Week 24Population: This analysis includes participants who completed the Week 24 study visit.
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).
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=25 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Participant Satisfaction With Overall Program
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9.9 units on a scale
Standard Deviation 0.3
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
Body composition will be assessed by weight in kilograms (kg).
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Weight
Baseline
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93.9 kilograms
Standard Error 2.2
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Weight
Week 12
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90.7 kilograms
Standard Error 2.0
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Weight
Week 24
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90.1 kilograms
Standard Error 2.0
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per day.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Steps Per Day
Baseline
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12644.5 Steps per day
Standard Error 769
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Steps Per Day
Week 12
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11131.9 Steps per day
Standard Error 807.7
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Steps Per Day
Week 24
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9691.2 Steps per day
Standard Error 993.6
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
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.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Intake of Added Sugars
Baseline
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29.9 grams
Standard Error 3.5
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Intake of Added Sugars
Week 12
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32.2 grams
Standard Error 4.0
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Intake of Added Sugars
Week 24
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29.8 grams
Standard Error 4.4
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
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.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Intake of Fruit
Baseline
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2.2 servings of fruit
Standard Error 0.3
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Intake of Fruit
Week 12
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2.3 servings of fruit
Standard Error 0.5
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Intake of Fruit
Week 24
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1.7 servings of fruit
Standard Error 0.3
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
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.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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|---|---|
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Intake of Vegetables
Baseline
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3.2 servings of vegetables
Standard Error 0.3
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Intake of Vegetables
Week 12
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3.7 servings of vegetables
Standard Error 0.4
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Intake of Vegetables
Week 24
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3.1 servings of vegetables
Standard Error 0.3
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
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.
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Change in International Physical Activity Questionnaire (IPAQ) Score
Baseline
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2872.5 MET minutes per week
Standard Error 613.8
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Change in International Physical Activity Questionnaire (IPAQ) Score
Week 12
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4716.7 MET minutes per week
Standard Error 683.4
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Change in International Physical Activity Questionnaire (IPAQ) Score
Week 24
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5952.6 MET minutes per week
Standard Error 1236.9
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: This analysis includes participants who completed the indicated study visit.
Body composition will be assessed by waist circumference measured in centimeters (cm).
Outcome measures
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 Participants
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Waist Circumference
Baseline
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107.7 centimeters
Standard Error 1.6
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Waist Circumference
Week 12
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103.3 centimeters
Standard Error 1.5
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Waist Circumference
Week 24
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101.1 centimeters
Standard Error 1.5
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Adverse Events
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soccer-based Adaptation to the Diabetes Prevention Program (DPP)
n=41 participants at risk
Participants taking part in a 24 week soccer program as part of diabetes prevention. Participants completed online education modules during an initial 12 week conditioning phase where they participated in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants transitioned onto a soccer league team for the following 12 weeks where they continued to complete online modules and meet with the soccer coach monthly. During the soccer sessions and games participants were fitted with a wearable soccer-specific device to measure how much they move and their heart rate. Additionally, they were asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
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Musculoskeletal and connective tissue disorders
Mild injuries
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12.2%
5/41 • Number of events 5 • Information about adverse events was collected from the time participants began the intervention through the end of intervention assessment at Week 24.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place