DPPHoops: Recreational Basketball to Increase Participation in Diabetes Prevention

Sponsor

Kaiser Permanente (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05066542

Collaborator

(none)

100

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes PreDiabetes	Behavioral: NDPP + Basketball (BB) Behavioral: NDPP Standard of Care SOC	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study is interventional Efficacy trial for people at risk for type 2 diabetes. Participants will be randomized into the traditional DPP curriculum or DPP + basketball. Certified NDPP coaches will deliver the curriculum.The Traditional arm will receive the standard NDPP curriculum. The intervention arm will receive the NDPP curriculum and participate in group based exercise sessions. Both groups will submit weekly activity reports. Group evaluations are based on the percentage of participants achieving 5% weight loss at 12-months; self-reported dietary intake, physical activity and sleep time, HbA1c, fasting glucose, body composition, blood pressure, aerobic fitness, musculoskeletal fitness, quality of life, self-efficacy, motivation and depression symptoms at 12-months. Assessments will be conducted at baseline, 6 months, and at 12-months from study initiation. An additional 24-month measurement will be conducted to determine sustainability of program effects.The study is interventional Efficacy trial for people at risk for type 2 diabetes. Participants will be randomized into the traditional DPP curriculum or DPP + basketball. Certified NDPP coaches will deliver the curriculum.The Traditional arm will receive the standard NDPP curriculum. The intervention arm will receive the NDPP curriculum and participate in group based exercise sessions. Both groups will submit weekly activity reports. Group evaluations are based on the percentage of participants achieving 5% weight loss at 12-months; self-reported dietary intake, physical activity and sleep time, HbA1c, fasting glucose, body composition, blood pressure, aerobic fitness, musculoskeletal fitness, quality of life, self-efficacy, motivation and depression symptoms at 12-months. Assessments will be conducted at baseline, 6 months, and at 12-months from study initiation. An additional 24-month measurement will be conducted to determine sustainability of program effects.

Masking:

Single (Participant)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 11, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Blood pressure [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean systolic and diastolic blood pressure (mm Hg)
HbA1c [12 month]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean HbA1c (percent)
Aerobic Fitness [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean aerobic fitness (ml/kg/min)
Lipid profile [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean handgrip strenght (pounds)
Session attendance [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean number of program sessions attended
Physical activity [12 months]
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
Waist Circumference [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean waist circumference (cm)
% Fat [12 months]
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean % body fat derived from impedance measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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