- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03595384
Soccer-based Adaptation of the Diabetes Prevention Program
Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- Emory University Rollins School of Public Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Soccer-based adaptation to the DPP
Hispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants Completing the Study
Tidsram: Week 24
|
Feasibility of the study will be assessed by the number of participants completing the study.
|
Week 24
|
Participant Satisfaction With Overall Program
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight
Tidsram: Baseline, Week 12, Week 24
|
Body composition will be assessed by weight in kilograms (kg).
|
Baseline, Week 12, Week 24
|
Steps Per Day
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, Week 12, Week 24
|
Body composition will be assessed by waist circumference measured in centimeters (cm).
|
Baseline, Week 12, Week 24
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Felipe Lobelo, MD, Emory University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00100342
- P30DK111024 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
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