Lifestyle Program for Type 2 Diabetes

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

180 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PILI Lifestyle Program + Social Determinants of Health (SDOH) Component for Type 2 Diabetes?

Research shows that lifestyle interventions, which include changes in diet and exercise, can successfully reduce the incidence of type 2 diabetes and help manage the condition. Programs like the Diabetes Prevention Program (DPP) have been effective in diverse groups, suggesting that similar lifestyle programs could be beneficial for managing type 2 diabetes. ^{1 2 3 4 5}

Is the Lifestyle Program for Type 2 Diabetes safe for humans?

The research articles reviewed do not provide specific safety data for the Lifestyle Program for Type 2 Diabetes or its variations, such as the PILI Lifestyle Program + Social Determinants of Health Component. ^{1 6 7 8 9}

What makes the PILI Lifestyle Program + SDOH Component treatment unique for type 2 diabetes?

The PILI Lifestyle Program + SDOH Component is unique because it combines lifestyle changes with a focus on social determinants of health, addressing both personal habits and external social factors that affect diabetes management, unlike traditional treatments that often focus solely on medication or diet. ^{3 10 11 12 13}

What is the purpose of this trial?

Native Hawaiians and Pacific Islanders (NHPIs) are defined as the descendants of the original peoples of Polynesia (e.g., Hawai'i, Sāmoa, and Tonga), Melanesia (e.g., Fiji), and Micronesia (e.g., Guam, Chuuk, and Marshall Islands). Their history with the U.S. parallels that of American Indians and Alaska Natives. Before Western contact, NHPIs had thriving societies with rich cultural traditions. After contact, NHPI communities were decimated to near extinction by infectious diseases, exploited for their cultural and natural resources, displaced from their ancestral lands, forced to assimilate to Western ways, and marginalized through legislative acts and compulsory assimilation policies (i.e., banning native language). The consequences have been high rates of cardiometabolic medical conditions, such as obesity, hypertension, type 2 diabetes, and cardiovascular disease. These medical conditions are, in part, a result of cultural disruptions and displacement that altered the traditional practices of NHPI and led to poor social determinants of health (SDOH). The basic premise of our project is that Community Health Workers (CHWs) can accelerate health equity for NHPI communities by disseminating and implementing culturally responsive, evidence-based interventions to prevent cardiometabolic medical conditions and improve their SDOH. The purpose of this project is to test the potential efficacy of the PILI Lifestyle Program (PLP) with integrated social determinants of health (SDOH) components and have it delivered by NHPI Community Health Workers (CHWs) to NHPIs with cardiometabolic-related conditions in a two-arm pilot randomized controlled trial (RCT) using a waitlist control. The investigators will evaluate the efficacy of the PLP+SDOH in improving the primary outcomes of hemoglobin A1c (HbA1c), systolic blood pressure, cholesterol, and weight in 180 adult NHPIs with pre-diabetes/type 2 diabetes, hypertension, dyslipidemia, and/or overweight/obesity.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Racial/ethnic and socioeconomic disparities in weight outcomes, cardiovascular events, and mortality in the look AHEAD trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Racial and Ethnic Approaches to Community Health (REACH) Detroit partnership: improving diabetes-related outcomes among African American and Latino adults. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Role of obesity and lifestyle interventions in the prevention and management of type 2 diabetes. [2009]

6. England pubmed.ncbi.nlm.nih.gov

Six-month outcomes from living well with diabetes: A randomized trial of a telephone-delivered weight loss and physical activity intervention to improve glycemic control. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC's National Diabetes Prevention Program. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinic- and Community-Based National Diabetes Prevention Programs in Los Angeles. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Individuals at high risk for type 2 diabetes invited to a lifestyle program: characteristics of participants versus non-participants (the HUNT Study) and 24-month follow-up of participants (the VEND-RISK Study). [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Systematic review of salutogenic-oriented lifestyle randomised controlled trials for adults with type 2 diabetes mellitus. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Lifestyle Africa: an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Integrated Intervention to Address Clinical Care and Social Needs Among Patients with Type 2 Diabetes. [2023]

13. Italy pubmed.ncbi.nlm.nih.gov

An innovative model for changing the lifestyles of persons with obesity and/or Type 2 diabetes mellitus. [2021]