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Soccer-based Adaptation of the Diabetes Prevention Program

10 sierpnia 2022 zaktualizowane przez: Roberto Felipe Lobelo, Emory University

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

41

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Emory University Rollins School of Public Health

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

35 lat do 55 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Męski

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Soccer-based adaptation to the DPP
Hispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Completing the Study
Ramy czasowe: Week 24
Feasibility of the study will be assessed by the number of participants completing the study.
Week 24
Participant Satisfaction With Overall Program
Ramy czasowe: Week 24
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Weight
Ramy czasowe: Baseline, Week 12, Week 24
Body composition will be assessed by weight in kilograms (kg).
Baseline, Week 12, Week 24
Steps Per Day
Ramy czasowe: Baseline, Week 12, Week 24
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
Ramy czasowe: Baseline, Week 12, Week 24
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
Ramy czasowe: Baseline, Week 12, Week 24
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
Ramy czasowe: Baseline, Week 12, Week 24
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
Ramy czasowe: Baseline, Week 12, Week 24
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
Ramy czasowe: Baseline, Week 12, Week 24
Body composition will be assessed by waist circumference measured in centimeters (cm).
Baseline, Week 12, Week 24

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Emory University

Współpracownicy

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Southern Denmark
Georgia Center for Diabetes Translation Research

Śledczy

  • Główny śledczy: Felipe Lobelo, MD, Emory University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 kwietnia 2018

Zakończenie podstawowe (Rzeczywisty)

16 grudnia 2018

Ukończenie studiów (Rzeczywisty)

16 grudnia 2018

Daty rejestracji na studia

Pierwszy przesłany

11 lipca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 lipca 2018

Pierwszy wysłany (Rzeczywisty)

23 lipca 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 sierpnia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 sierpnia 2022

Ostatnia weryfikacja

1 sierpnia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00100342
  • P30DK111024 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Deidentified individual participant data supporting the conclusions of this study are available for sharing with other researchers.

Ramy czasowe udostępniania IPD

Raw data are available for sharing following publication of the results of this study.

Kryteria dostępu do udostępniania IPD

Access to the data can be obtained by emailing the study investigators.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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