Recreational Basketball to Increase Participation in Diabetes Prevention (DPPHoops)

Leveraging Recreational Basketball to Increase Participation in the National Diabetes Prevention Program (NDPP) Among Adults Aged 18-44 Years at Kaiser Permanente Georgia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: NDPP Standard of Care SOC; Behavioral: NDPP + Basketball (BB)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Kaiser Permanente Georgia, Center for Research and Evaluation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: NDPP; Diabetes Prevention Program DPP
Experimental: 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.	Behavioral: 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.; Other Names: DPP Hoops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Weight Loss Efficacy	Compare percent of program participants achieving 5% or more weight loss between the DPP Standard of care group and the DPP+BB intervention group.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean systolic and diastolic blood pressure (mm Hg)	12 months
HbA1c	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean HbA1c (percent)	12 month
Aerobic Fitness	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean aerobic fitness (ml/kg/min)	12 months
Lipid profile	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean handgrip strenght (pounds)	12 months
Session attendance	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean number of program sessions attended	12 months
Physical activity	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean minutes per day of objectively measured sedentary, moderate and vigorous physical activity	12 months
Waist Circumference	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean waist circumference (cm)	12 months
% Fat	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean % body fat derived from impedance measurements	12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Prediabetes; Weight loss; Basketball; National Diabetes Prevention Program
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: KP1546327; KPR-SM-2020-01/1 (Other Grant/Funding Number: Kaiser Permanente and National Basketball Association)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No