Recreational Basketball to Increase Participation in Diabetes Prevention

NCT ID: NCT05066542

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2026-03-30

Brief Summary

The purpose of this study is to assess the efficacy of adapting the National Diabetes Prevention Program (NDPP) to include recreational sports in effort to increase physical activity (PA) and promote lifestyle changes that can help reduce the risk of developing Type 2 Diabetes Mellitus. The hypothesis is that both the traditional NDPP and the NDPP+ Basketball will be considered feasible. The primary outcome is to assess whether the intervention (NDPP+BB) compared to the standard of care (NDPP only) will result in greater weight loss, lower A1c, and increased engagement in physical activity.

Detailed Description

The NDPP has successfully helped to reduce the rate of Type 2 Diabetes Mellitus (T2DM) through moderate weight loss and increased physical activity(PA). Kaiser Permanente Georgia (KPGA) members, identified as being at risk to develop type 2 diabetes will be recruited to participate in the intervention trial testing DPP vs. NDPP+ BB study arms. Participants will be randomized into 1 of 2 groups (traditional DPP curriculum or DPP + basketball).

The central objective of this project is to determine the feasibility of adapting the NDPP to include recreational basketball as an exercise component among KPGA population of overweight, pre-diabetic adults ages 18-44 using novel translational science approach and qualitative formative research tools. The secondary objective is to implement the adapted NDPP + BB program among a pre-diabetic KPGA adult members, 18-44 years living in Atlanta and determine post-program efficacy in achieving the desired 5 percent weight loss goal.

The objective is to contribute beneficial information to clinical and operational leaders across KP and beyond, as they consider approaches to improve overall participation rates in the NDPP, particularly for young and middle-aged adult members, leveraging interest in a popular recreational team-based sport such as BB. Longer-term, the goal is to reduce diabetes risk.

Conditions

Type 2 Diabetes; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

NDPP Standard of Care SOC

Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches. During Months 1-4 participants will attend a 60-minute virtually facilitated session of the NDPP curriculum. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Group Type: ACTIVE_COMPARATOR

NDPP Standard of Care SOC

Intervention Type: BEHAVIORAL

DPP: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches. During Months 1-4 participants will attend a 60-minute virtually facilitated session of the NDPP curriculum. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

NDPP + Basketball (BB)

Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches along with virtual fitness sessions and in-person basketball sessions. During Months 1-4, participants will attend a 60-minute virtually facilitated session of the NDPP curriculum, followed by a 30-minute virtual fitness session. During that same week, participants will meet in person, for a 90-minute BB session. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks and there will no longer be a 30-minute online fitness session succeeding the session. During this same four-month period, 60-minute, in-person BB sessions will be held weekly. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session and bi-weekly 60-minute in-person BB sessions. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Group Type: EXPERIMENTAL

NDPP + Basketball (BB)

Intervention Type: BEHAVIORAL

DPP Hoops: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches along with virtual fitness sessions and in-person basketball sessions. During Months 1-4, participants will attend a 60-minute virtually facilitated session of the NDPP curriculum, followed by a 30- minute virtual fitness session. During that same week, participants will meet in person, for a 90-minute BB session. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks and there will no longer be a 30-minute online fitness session succeeding the session. During this same four-month period, 60-minute, in-person BB sessions will be held weekly. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session and biweekly 60-minute in-person BB sessions. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Interventions

NDPP + Basketball (BB)

DPP Hoops: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches along with virtual fitness sessions and in-person basketball sessions. During Months 1-4, participants will attend a 60-minute virtually facilitated session of the NDPP curriculum, followed by a 30- minute virtual fitness session. During that same week, participants will meet in person, for a 90-minute BB session. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks and there will no longer be a 30-minute online fitness session succeeding the session. During this same four-month period, 60-minute, in-person BB sessions will be held weekly. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session and biweekly 60-minute in-person BB sessions. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Intervention Type: BEHAVIORAL

NDPP Standard of Care SOC

DPP: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches. During Months 1-4 participants will attend a 60-minute virtually facilitated session of the NDPP curriculum. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Intervention Type: BEHAVIORAL

Other Intervention Names

DPP Hoops; NDPP; Diabetes Prevention Program DPP

Eligibility Criteria

Inclusion Criteria

• Aged 18-44 years
• BMI >= 25 kg/m2
• Previous diagnosis of prediabetes as defined:
• HbA1c 5.7 to 6.4% at baseline
• Not engaged in high exercise levels (self-report of less than 300 minutes of exercise per week)
• Not engaged in other lifestyle intervention program in past 2 years
• Ability to read in English and provide informed consent
• Ability to walk unassisted for 30 minutes
• Ability to jump in place

Exclusion Criteria

• Diabetes due to underlying conditions
• Type 1 Diabetes
• Type 2 Diabetes
• End Stage Renal Disease (ESRD)
• Myocardial Infarction within the last 12 months
• Cancer treatment
• Congestive Heart Disease
• Not currently pregnant
• Any history of seizures or uncontrolled neurologic or psychiatric condition that may interfere with the intervention plan

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Felipe Lobelo

Physician Program Director Epidemiology, Public Health and Preparedness, TSPMG

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaiser Permanente Georgia, Center for Research and Evaluation

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

KPR-SM-2020-01/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KP1546327

Identifier Type: -

Identifier Source: org_study_id