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Recreational Basketball to Increase Participation in Diabetes Prevention (DPPHoops)

Primary Purpose

Type 2 Diabetes, PreDiabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDPP + Basketball (BB)
NDPP Standard of Care SOC
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Prediabetes, National Diabetes Prevention Program, Weight loss, Physical Activity, Basketball

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Georgia, Center for Research and Evaluation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NDPP Standard of Care SOC

NDPP + Basketball (BB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
HbA1c
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean HbA1c (percent)
Aerobic Fitness
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean aerobic fitness (ml/kg/min)
Lipid profile
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean handgrip strenght (pounds)
Session attendance
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean number of program sessions attended
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
Waist Circumference
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean waist circumference (cm)
% Fat
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean % body fat derived from impedance measurements

Full Information

First Posted
September 8, 2021
Last Updated
September 24, 2021
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT05066542
Brief Title
Recreational Basketball to Increase Participation in Diabetes Prevention
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, PreDiabetes
Keywords
Prediabetes, National Diabetes Prevention Program, Weight loss, Physical Activity, Basketball

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NDPP Standard of Care SOC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NDPP + Basketball (BB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NDPP + Basketball (BB)
Other Intervention Name(s)
DPP Hoops
Intervention Description
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
Intervention Name(s)
NDPP Standard of Care SOC
Other Intervention Name(s)
NDPP, Diabetes Prevention Program DPP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Weight Loss Efficacy
Description
Compare percent of program participants achieving 5% or more weight loss between the DPP Standard of care group and the DPP+BB intervention group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean systolic and diastolic blood pressure (mm Hg)
Time Frame
12 months
Title
HbA1c
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean HbA1c (percent)
Time Frame
12 month
Title
Aerobic Fitness
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean aerobic fitness (ml/kg/min)
Time Frame
12 months
Title
Lipid profile
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean handgrip strenght (pounds)
Time Frame
12 months
Title
Session attendance
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean number of program sessions attended
Time Frame
12 months
Title
Physical activity
Description
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
Time Frame
12 months
Title
Waist Circumference
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean waist circumference (cm)
Time Frame
12 months
Title
% Fat
Description
Compare changes between the DPP Standard of care group and the DPP+BB intervention group in mean % body fat derived from impedance measurements
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Kaiser Permanente Georgia, Center for Research and Evaluation
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Recreational Basketball to Increase Participation in Diabetes Prevention

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