Clinical trial NCT03595384: Soccer-based Adaptation of the Diabetes Prevention Program
Official title: Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Behavioral intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Diabetes Translation Research
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Southern Denmark
First posted: 2018-07-23
Enrollment: 41
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Completing the Study
timeFrame: Week 24
measure: Participant Satisfaction With Overall Program
timeFrame: Week 24
Secondary outcomes:
measure: Weight
timeFrame: Baseline, Week 12, Week 24
measure: Steps Per Day
timeFrame: Baseline, Week 12, Week 24
measure: Intake of Added Sugars
timeFrame: Baseline, Week 12, Week 24
measure: Intake of Fruit
timeFrame: Baseline, Week 12, Week 24
measure: Intake of Vegetables
timeFrame: Baseline, Week 12, Week 24
measure: Change in International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Baseline, Week 12, Week 24
measure: Waist Circumference
timeFrame: Baseline, Week 12, Week 24
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Rollins School of Public Health
state: Georgia
Study officials:
affiliation: Emory University
name: Felipe Lobelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 10.3389/fspor.2021.757815. eCollection 2021.