Recreational Basketball to Increase Participation in Diabetes Prevention

NCT05066542 | Active Not Recruiting DMC

• 2 other identifiers: KP1546327KPR-SM-2020-01/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; PreDiabetes

Keywords

Prediabetes; National Diabetes Prevention Program; Weight loss; Physical Activity; Basketball

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Blood pressure

  12 months

• HbA1c

  12 month

• Aerobic Fitness

  12 months

• Lipid profile

  12 months

• Session attendance

  12 months

Study Arms (2)

NDPP Standard of Care SOC

ACTIVE COMPARATOR

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

NDPP + Basketball (BB)

EXPERIMENTAL

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)

Interventions

NDPP + Basketball (BB) BEHAVIORAL

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.

Also known as: DPP Hoops

NDPP + Basketball (BB)

NDPP Standard of Care SOC BEHAVIORAL

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.

Also known as: NDPP, Diabetes Prevention Program DPP

NDPP Standard of Care SOC

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Georgia, Center for Research and Evaluation

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Weight Loss; Motor Activity

Interventions

4-nitro-3-dimethylaminopropiophenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Program Director Epidemiology, Public Health and Preparedness, TSPMG

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 4, 2021
• Study Start: June 11, 2021
• Primary Completion: November 30, 2023
• Study Completion: March 30, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

US (1)