Soccer-based Adaptation of the Diabetes Prevention Program

NCT03595384 | Completed Results

• 2 other identifiers: IRB00100342P30DK111024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Weight

  Baseline, Week 12, Week 24

• Steps Per Day

  Baseline, Week 12, Week 24

• Intake of Added Sugars

  Baseline, Week 12, Week 24

• Intake of Fruit

  Baseline, Week 12, Week 24

• Intake of Vegetables

  Baseline, Week 12, Week 24

Study Arms (1)

Soccer-based adaptation to the DPP

EXPERIMENTAL

Hispanic overweight male participants taking part in a 24 week soccer program as part of diabetes prevention.

Behavioral: Soccer-based adaptation to the DPP

Interventions

Soccer-based adaptation to the DPP BEHAVIORAL

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.

Soccer-based adaptation to the DPP

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Georgia Center for Diabetes Translation Research: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Emory University Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

Related 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.

  PMID: 32603753 BACKGROUND

• 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.

  PMID: 34870194 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jennifer K Frediani PhD, RD
• Organization: Emory University

jfredia@emory.edu

404-727-3766

Study Officials

• Felipe Lobelo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: April 29, 2018
• Primary Completion: December 16, 2018
• Study Completion: December 16, 2018
• Last Updated: August 12, 2022
• Results First Posted: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Raw data are available for sharing following publication of the results of this study.
• Access Criteria: Access to the data can be obtained by emailing the study investigators.

Locations

US (1)