Soccer-based Adaptation of the Diabetes Prevention Program

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Soccer-based adaptation to the DPP

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Rollins School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Soccer-based adaptation to the DPP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Completing the Study	Feasibility of the study will be assessed by the number of participants completing the study.	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).	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body composition will be assessed by weight in kilograms (kg).	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.	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.	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.	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.	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.	Baseline, Week 12, Week 24
Waist Circumference	Body composition will be assessed by waist circumference measured in centimeters (cm).	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Southern Denmark; Georgia Center for Diabetes Translation Research
• Investigators: Principal Investigator: Felipe Lobelo, MD, Emory University

Publications and helpful links

General 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.
• 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: 10.3389/fspor.2021.757815. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2018
• Primary Completion (Actual): December 16, 2018
• Study Completion (Actual): December 16, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Behavioral intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB00100342; P30DK111024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data supporting the conclusions of this study are available for sharing with other researchers.
• IPD Sharing Time Frame: Raw data are available for sharing following publication of the results of this study.
• IPD Sharing Access Criteria: Access to the data can be obtained by emailing the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No