Recreational Basketball to Increase Participation in Diabetes Prevention

Type 2 Diabetes Clinical Trial

— DPPHoops  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05066542
• Other study ID #: KP1546327
• Secondary ID: KPR-SM-2020-01/1
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Georgia, Center for Research and Evaluation	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HbA1c	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean HbA1c (percent)	12 month
Secondary	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
Secondary	Lipid profile	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean handgrip strenght (pounds)	12 months
Secondary	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
Secondary	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
Secondary	Waist Circumference	Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean waist circumference (cm)	12 months
Secondary	% 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