Soccer-based Adaptation of the Diabetes Prevention Program

Diabetes Clinical Trial

Official title:

Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595384
• Other study ID #: IRB00100342
• Secondary ID: P30DK111024
• Status: Completed
• Phase: N/A
• Start date: April 29, 2018
• Est. completion date: December 16, 2018

Study information

• Verified date: August 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 16, 2018
• Est. primary completion date: December 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Rollins School of Public Health	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Southern Denmark

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Frediani 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: 10.3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Completing the Study	Feasibility of the study will be assessed by the number of participants completing the study.	Week 24
Primary	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).	Week 24
Secondary	Weight	Body composition will be assessed by weight in kilograms (kg).	Baseline, Week 12, Week 24
Secondary	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.	Baseline, Week 12, Week 24
Secondary	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.	Baseline, Week 12, Week 24
Secondary	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.	Baseline, Week 12, Week 24
Secondary	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.	Baseline, Week 12, Week 24
Secondary	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.	Baseline, Week 12, Week 24
Secondary	Waist Circumference	Body composition will be assessed by waist circumference measured in centimeters (cm).	Baseline, Week 12, Week 24