Leveraging Recreational Basketball to Increase Participation in the National Diabetes Prevention Program (NDPP) Among Adults Aged 18-44 Years at Kaiser Permanente Georgia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent Weight Loss Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: NDPP + Basketball (BB) (Behavioral)
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.
干预措施: NDPP Standard of Care SOC (Behavioral)
结局指标
主要结局
Percent Weight Loss Efficacy
时间窗: 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.
次要结局
- Blood pressure(12 months)
- Aerobic Fitness(12 months)
- Lipid profile(12 months)
- Physical activity(12 months)
- Waist Circumference(12 months)
- % Fat(12 months)
- Session attendance(12 months)
- HbA1c(12 month)
研究者
Felipe Lobelo
Physician Program Director Epidemiology, Public Health and Preparedness, TSPMG
Kaiser Permanente