Clinical trial NCT05066542: Recreational Basketball to Increase Participation in Diabetes 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Keywords: Prediabetes
National Diabetes Prevention Program
Weight loss
Physical Activity
Basketball
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percent Weight Loss Efficacy
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 month
measure: Aerobic Fitness
timeFrame: 12 months
measure: Lipid profile
timeFrame: 12 months
measure: Session attendance
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Waist Circumference
timeFrame: 12 months
measure: % Fat
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia, Center for Research and Evaluation
state: Georgia
Study officials:
References: