Lifestyle Program for Type 2 Diabetes

No longer recruiting at 9 trial locations

Overseen By Claire Ing, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Not NHPI, Under 18, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the PILI Lifestyle Program, which includes a Social Determinants of Health (SDOH) Component, can improve health for Native Hawaiians and Pacific Islanders (NHPIs) with conditions such as type 2 diabetes, high blood pressure, high cholesterol, or obesity. Community health workers from NHPI communities run the program, offering lessons on lifestyle changes and activities to enhance overall well-being. Participants will join either the intervention group, which starts immediately, or a waitlist. The trial seeks NHPIs diagnosed by a doctor with one or more of these conditions. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health outcomes for the community.

Will I have to stop taking my current medications?

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 PILI Lifestyle Program is safe for Native Hawaiians and Pacific Islanders?

Research has shown that lifestyle programs like the PILI Lifestyle Program are based on successful diabetes prevention programs. These programs typically focus on dietary and exercise changes to help manage or prevent type 2 diabetes. Although specific safety data for the PILI Lifestyle Program is not available, lifestyle programs are generally safe as they involve altering daily habits rather than using medication or undergoing medical procedures.

Past studies on similar lifestyle programs indicate that participants generally fare well. These programs emphasize healthy eating and physical activity, integral parts of everyday life. No serious problems have been reported from these types of programs.

It is important to note that this trial tests the program's effectiveness, not a new drug or risky procedure, which means the risks are quite low. Participants often find these programs beneficial in improving health factors like blood sugar, blood pressure, and weight, especially with guidance from trained community health workers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PILI Lifestyle Program combined with a Social Determinants of Health (SDOH) component because it takes a holistic approach to managing Type 2 Diabetes. Unlike standard treatments that primarily focus on medication and diet changes, this program integrates lifestyle education with real-world social factors that affect health, like community support and access to resources. This innovative approach aims to empower participants by addressing underlying social and behavioral factors, potentially leading to more sustainable long-term health improvements.

What evidence suggests that the PILI Lifestyle Program might be an effective treatment for type 2 diabetes?

Studies have shown that the PILI Lifestyle Program (PLP), combined with activities addressing social factors affecting health, can significantly improve health for individuals with type 2 diabetes and related conditions. In this trial, participants in the Intervention Group will receive the PLP+SDoH curriculum, which research indicates can lead to weight loss, a crucial factor in managing diabetes. The PILI 'Ohana Project, an earlier version of this program, used methods from successful diabetes prevention programs and helped individuals improve their lifestyle habits. These changes can lead to better control of blood sugar, blood pressure, and cholesterol. Overall, the PLP+SDoH approach is designed to be culturally relevant and supportive, offering a promising option for Native Hawaiian and Pacific Islander communities facing these health challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Joseph K Kaholokula, PhD

Principal Investigator

University of Hawaii

Sheri Daniels, PhD

Principal Investigator

Papa Ola Lokahi

Nia Aitaoto, PhD

Principal Investigator

National Association of Pasifika Organizations

Are You a Good Fit for This Trial?

This trial is for adult Native Hawaiians and Pacific Islanders with conditions like pre-diabetes, type 2 diabetes, high blood pressure, dyslipidemia, or overweight/obesity. It's designed to help improve their health by addressing both lifestyle factors and social determinants of health.

Exclusion Criteria

I am under 18, of NHPI descent, and do not have any heart or metabolic conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PILI Lifestyle Program (PLP) + Social Determinants of Health (SDOH) intervention over 3 months, delivered by Community Health Workers (CHWs).

12 weeks

Weekly sessions (1-1.5 hours each)

Follow-up

Participants are monitored for changes in hemoglobin A1c, blood pressure, cholesterol, and weight after the intervention.

4 weeks

Waitlist Control

Participants in the control group receive no intervention during the initial 3 months but are offered the PLP+SDOH curriculum after the follow-up assessment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PILI Lifestyle Program + Social Determinants of Health (SDOH) Component

Trial Overview

The PILI Lifestyle Program combined with a Social Determinants of Health component is being tested. Delivered by Community Health Workers, this study aims to see if the program can lower hemoglobin A1c levels, blood pressure, cholesterol levels, and weight in participants.

How Is the Trial Designed?

Group I: Intervention Group - PLP + SDoH Experimental Treatment 1 Intervention

Participants randomized to the Intervention Group will be engaged in a 3-month randomized controlled trial and receive the PLP+SDoH curriculum from a trained Community Health Worker (CHW). Each week during the 3 months, participants will meet for approximately 1-1.5 hours and be taught a PLP Lesson or engage in an SDoH activity. Participants will also be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time.

Group II: Waitlist Control Group Active Control 1 Intervention

Participants randomized to the Waitlist Control Group will receive nothing from the research group while the Intervention Group is underway. Participants will be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time. After the Control Group's 3-month follow-up assessment, they will be offered the PLP+SDoH curriculum.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

National Association of Pasifika Organizations

Collaborator

Trials

1

Recruited

270+

Papa Ola Lōkahi

Collaborator

Trials

1

Recruited

270+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The CURIAMO project involves a multidisciplinary lifestyle intervention for obesity and Type 2 diabetes, engaging around 1000 adults over a 3-year period, with a focus on achieving significant weight loss and increased physical activity.

The intervention aims for at least 70% of participants to lose 7% of their body weight and increase their physical activity by 10 MET/h-1·week-1 after one year, indicating a strong potential for long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative model for changing the lifestyles of persons with obesity and/or Type 2 diabetes mellitus. De Feo, P., Fatone, C., Burani, P., et al.[2021]

The Diabetes Prevention Program translated into the Group Lifestyle Balance (DPP-GLB) was effective in promoting significant weight loss among participants, but non-Hispanic white individuals lost more weight than non-Hispanic black participants at both 6 and 12 months, indicating a disparity in outcomes based on race/ethnicity.

While the program initially helped reduce disparities in physical activity levels, differences in achieving activity goals re-emerged after 12 months, highlighting the need for tailored interventions to better support marginalized groups in maintaining behavioral goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. Devaraj, SM., Napoleone, JM., Miller, RG., et al.[2022]

There is no international consensus on how to classify individuals at high risk for Type 2 diabetes, leading to ongoing debates about the best laboratory tests and thresholds for diagnosis.

Countries are increasingly focusing on preventing Type 2 diabetes through large-scale lifestyle interventions that empower high-risk individuals to make beneficial changes, alongside broader public health strategies to address obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do we identify people at high risk of Type 2 diabetes and help prevent the condition from developing? Fagg, J., Valabhji, J.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4927448/

The PILI@Work Program: a translation of the diabetes ...

This study examined the effectiveness of PILI@Work and factors associated with weight loss at post-intervention. Overweight/obese employees of ...

2.

withpower.com

withpower.com/trial/phase-diabetes-mellitus-6-2024-b4e77

Lifestyle Program for Type 2 Diabetes · Info for Participants

Participants receive the PILI Lifestyle Program (PLP) + Social Determinants of Health (SDOH) intervention over 3 months, delivered by Community Health Workers ( ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4271354/

The PILI 'Ohana Project: A Community-Academic ...

Originally a nine-month behavioral lifestyle intervention with two phases, the POP adapted the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06526273

Study Details | NCT06526273 | PILI 'Āina Household

The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and ...

5.

ctv.veeva.com

ctv.veeva.com/study/peau-o-le-vasa-analysis-of-the-efficacy-and-feasibility-of-the-pili-lifestyle-program-plp-socia

Peau o le Vasa: Analysis of the Efficacy and Feasibility of the ...

The purpose of this project is to test the potential efficacy of the PILI Lifestyle Program (PLP) with integrated social determinants of health (SDOH) ...

6.

researchgate.net

researchgate.net/publication/42975922_Translating_Diabetes_Prevention_Into_Native_Hawaiian_and_Pacific_Islander_Communities_The_PILI_'Ohana_Pilot_Project

Translating Diabetes Prevention Into Native Hawaiian and ...

Translation of empirically tested interventions such as the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) offers the potential for ...