Diabetes Prevention Program for Obesity

(SCULPT-Job Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Diabetes, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various factors influence weight loss, weight maintenance, and heart health in people from diverse backgrounds. The focus is on a YMCA program aimed at preventing diabetes and managing obesity through behavior changes over a year. It may suit individuals over 18 who struggle with obesity and come from varied socioeconomic backgrounds. As an unphased study, this trial offers a unique opportunity to contribute to important research that could benefit many people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Diabetes Prevention Program is safe?

Research shows that the Diabetes Prevention Program (DPP) is safe and easy to follow. The program helps people make lifestyle changes to prevent diabetes. Studies have found that it can lower the risk of developing type 2 diabetes by 58%. For people aged 60 and older, this risk reduction increases to 71%. These results suggest that the program is safe for participants, with no evidence of serious side effects. The YMCA runs the program, which lasts for 12 months. During this time, participants focus on healthier lifestyle choices, including changes to diet and exercise. Overall, the DPP effectively reduces the risk of diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Diabetes Prevention Program (DPP) is unique because it focuses on behavioral changes rather than medication to prevent diabetes. Unlike standard treatments that often involve medication to manage blood sugar levels, the DPP emphasizes lifestyle modifications like diet and exercise, which are implemented through a structured program run by the YMCA over 12 months. Researchers are excited about this approach because it empowers participants to take control of their health through sustainable habits, potentially reducing the risk of developing diabetes without relying solely on medication.

What evidence suggests that the Diabetes Prevention Program is effective for obesity?

Research has shown that the Diabetes Prevention Program (DPP), which participants in this trial will undergo, can greatly reduce the risk of developing type 2 diabetes. Studies have found that people in the DPP Lifestyle Change Program lowered their risk of diabetes by 58% over about three years. The program helps participants lose 5 to 7 percent of their body weight, which is crucial for its success. A long-term follow-up study supported these findings, showing that the benefits can last for many years. The DPP focuses on lifestyle changes proven to help prevent diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Michelle A Albert, MD

Principal Investigator

University of California, SF

Are You a Good Fit for This Trial?

The SCULPT-Job Cohort Study is for adults over 18 with a BMI above 25 (or above 22 for Asian ethnicity), from various socioeconomic backgrounds. It's not for those with certain cognitive conditions, active housing issues, recent mothers, recent orthopedic surgery patients, non-speakers of English/Spanish/Chinese, or people with diabetes or recent severe heart problems.

Inclusion Criteria

BMI > 25 kg/m2 (for Asian ethnicity BMI > 22 kg/m2)

Includes participants from socioeconomically diverse backgrounds

I am older than 18 years.

Exclusion Criteria

History of physician diagnosed cognitive, developmental or psychiatric conditions

Persons facing housing eviction or undergoing an active housing leasing process (e.g getting their credit report in shape for a potential lease, in the process of getting a new housing lease)

Pregnancy or post-partum state (< 12 months post-partum)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Diabetes Prevention Program (DPP) for weight loss and cardiovascular health improvement

12 months

Regular visits as per DPP schedule

Maintenance

Participants are monitored for BMI maintenance and cardiovascular health

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program

Trial Overview This study tests the Diabetes Prevention Program to see how it affects weight loss and maintenance as well as cardiovascular health in socially disadvantaged individuals. The focus is on clinical outcomes alongside psychosocial and behavioral factors.

How Is the Trial Designed?

Group I: Diabetes Prevention Program Experimental Treatment 1 Intervention

The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

3. cdc.gov cdc.gov/diabetes-prevention/programs/what-is-the-national-dpp.html

What Is the National DPP? | National Diabetes Prevention ... Results from the study showed that this structured lifestyle change program—in which participants achieved weight loss of 5 to 7 percent of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00038727

Diabetes Prevention Program Outcomes Study The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to ...

5. coveragetoolkit.org coveragetoolkit.org/about-national-dpp/evidence/

Evidence The 15-year follow up study substantiated that diabetes incidence was reduced by 27% in the group that experienced the intervention, and that “cumulative ...

6. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

7. diabetesjournals.org diabetesjournals.org/care/article/48/7/1150/160620/The-U-S-National-Diabetes-Prevention-Program-NDPP

The US National Diabetes Prevention Program (NDPP ... The absolute risk difference of 2.8% translates to a number needed to treat of 36 people for 2 years to prevent one case of diabetes. Past ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00004992

Study Details | NCT00004992 | Diabetes Prevention Program Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes.

9. hopkinsmedicine.org hopkinsmedicine.org/population-health/dpep/diabetes-prevention-program

Diabetes Prevention Program (DPP) DPP can reduce patient chances of developing type 2 diabetes by 58% (71% for individuals aged 60 and older) compared to usual care. What does it offer patients?