Weight Loss TrialNCT06471595
Peau o le Vasa: Analysis of the Efficacy and Feasibility of the PILI Lifestyle Program (PLP) + Social Determinants of Health (SDOH) Intervention and Adaptation of SDOH Measures Pilot Study
A study testing Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component in people with Weight Loss Trial and Cardiometabolic Syndrome, run by University of Hawaii at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss Trial, Cardiometabolic Syndrome, Hypertension
- What is being tested?
- Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NHPI participants over 18 years of age with a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])
Who cannot join
- Not NHPI, NHPI participants under 18 years of age, and without a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Association Of Pasifika Organizations
Fayetteville, Arkansas, 72704
Papa Ola Lokahi
Honolulu, Hawaii, 96813
Ke Ola Mamo
Honolulu, Hawaii, 96817
Arkansas Coalition of Marshallese
Springdale, Arkansas, 72764
About this study
Official title: Peau o le Vasa: Accelerating the Currents of Health Equity for Pasifika People
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.
Read the detailed description
Our target populations are Native Hawaiians and Pacific Islanders (NHPIs) 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 (HTN), type 2 diabetes (T2D), and cardiovascular disease (CVD). 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 colonization of the Pacific and SDOH disadvantages led to the proliferation of sedentary lifestyles and calorie-dense, nutrient-poor foods (e.g., processed and fast foods) that were inexpensive, accessible, and have become part of the daily diet of many NHPIs and a big contributor to their chronic disease risk. NHPIs have higher rates of obesity, HTN, T2D, and CVD as well as chronic kidney disease, a consequence of HTN and T2D when compared to non-Hispanic Whites. NHPIs get many of these conditions at younger ages than non-Hispanic Whites and Asian Americans. They are more likely to be diagnosed with multiple chronic medical conditions and at later stages or greater severity, to be readmitted to the hospital, and to be frequent users of the emergency room and outpatient services. NHPIs have the lowest life expectancy (nearly ten years lower) compared to non-Hispanic Whites and Asian Americans.
To address the cardiometabolic health inequities in NHPIs, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was culturally and contextually adapted for them and called the PILI Lifestyle Program (PLP). Based on NHPI community engagement, the PLP consolidated the original 16 DPP-LI lessons into 8 lessons delivered over 3 months, with two additional community-identified topics added into these lessons (i.e., economically healthy eating and talking with participants' doctor). The lessons offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management. At each lesson, participants develop an individualized plan using SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) goals. The cultural adaptions included making food, exercise, and other lifestyle examples relevant to NHPIs. PLP was designed to be group-delivered (10-12 people) by a trained, community-based peer educator across different types of settings. Each lesson can be delivered between 1 hour and 1.5 hours, depending on the size of the group. The 3-month PLP has been found effective for improving weight loss, blood pressure, and physical activity frequency and functioning and reducing the consumption of dietary fat in overweight/obese NHPIs with co-morbid cardiometabolic conditions.
SDOH, defined as the conditions in which people are born, live, learn, work, play, and age, affect a person's ability to adopt and maintain healthier behaviors. SDOH are underlying drivers of unfair and avoidable differences in the risk for cardiometabolic-related conditions. They include income, food security, social norms, segregation, and language and literacy. NHPIs face many SDOH disadvantages that serve as barriers to accessing healthier lifestyles and quality healthcare. The 2020 U.S. Census shows 22.7% of NHPIs live below the federal poverty level and 9.1% were uninsured compared to 10.3% and 6.3% of non-Hispanic Whites, respectively. NHPIs are overrepresented as Supplemental Nutrition Assistance Program (SNAP) and Women Infants and Children (WIC) beneficiaries. Food insecurity is 3 times greater among NHPIs compared to non-Hispanic Whites. In terms of education attainment, only 24% of NHPIs have a college degree compared to 37% of students overall in the U.S. The investigators have already identified the major SDOH challenges faced by NHPIs, such as economic stability, physical and neighborhood environment, education, food, community and social context, and health care system. If adapted to address SDOH barriers, lifestyle interventions, like the PLP, can improve their long-term effects on adopting and maintaining healthier behaviors.
CHWs, serving as frontline public health workers and trusted community resources, can effectively disseminate and implement cardiometabolic-related interventions across different settings. The trusting relationship CHWs have with communities enables them to serve as a liaison, link, and intermediary between health and social services and the community to facilitate access to services and improve the quality and cultural and linguistic competence of these services. When it comes to addressing the health needs of NHPI communities, NHPI CHWs are uniquely positioned to deliver effective interventions to improve cardiometabolic health outcomes and their social determinants. Studies of NHPI CHWs have shown that they can effectively deliver interventions for primary and secondary prevention of cardiometabolic conditions among at-risk NHPIs. For example, they are effective in delivering culturally tailored lifestyle interventions to improve overweight/obesity, hemoglobin A1c (HbA1c) in those with T2D, and blood pressure control in those with uncontrolled HTN. The authors of a 2015 systemic review of Asian American and NHPI CHW programs concluded that CHWs from these communities serve an important role in improving outcomes for these underserved communities because they are uniquely positioned to provide culturally and linguistically tailored disease management strategies and peer support. They also found a need to increase efforts in documenting and evaluating core competency-based training of CHW in Asian American and NHPI communities.
Thus, this project will test the efficacy of a 3-month PLP + SDOH curriculum. the investigators will enhance the PLP by adding an SDOH component. Following is a list of the lessons and potential SDOH activities. However, the specific activity may vary based on the group's participants and the CHW.
PLP Lesson: The Benefits of Lifestyle Change; Setting Goals; Ways to Stay Motivated.
PLP Lesson: Being Active; Exercising Safely; Three Ways to Eat Less Fat. PLP Lesson: Get Moving; Tracking Progress; Being a Fat Detective (Finding Hidden Fats); Move Those Muscles.
PLP Lesson: Healthy Eating with the Plate Method; 3 Right Ways to Healthy Eating Out; Heart-Strengthening Activities.
SDOH activity: Accessing healthier foods-e.g., Visit by Land Grant program to develop home gardens or vegetable boxes for apartment dwellers.
PLP Lesson: Tip the Calorie Balance; Economics of Healthy Eating (Meal Planning).
SDOH activity: Job/Career - e.g., Support in job search and training. PLP Lesson: Of What's Around You (Battling Temptation); Make Social Cues Work for You.
SDOH activity: Housing - e.g., Visit by the local housing authority (low-income housing) on rental/deposit assistance for low earners, housing co-op, etc.
PLP Lesson: Problem-Solving Skills (Exploring Options); Talking with the Doctor (General Skills for Effective Communication).
SDOH activity: Legal-e.g., Visit by local legal aid to assist with immigration/migrant issues and legal support services.
PLP Lesson: Managing Negative Thoughts and Emotions; Controlling Stress; Review of Lessons.
Fifteen experienced CHWs from our network will deliver the PLP+SDOH to eligible NHPIs. 15 cohorts of 10-12 NHPI (n=160) participants ≥18 years of age with a self-reported cardiometabolic condition (i.e., pre-diabetes/type 2 diabetes, hypertension, dyslipidemia, and/or overweight/obesity [BMI ≥ 25]) will be enrolled and randomized to either the PLP+SDOH arm or to the waitlist control arm. In cohorts of 10-12 participants at each of the 15 community settings, a 1:1 randomization will be done immediately following baseline assessment so that 5-6 will be randomized to PLP+SDOH and 5-6 to waitlist control per cohort. Overall, 80 participants will be randomized to PLP+SDOH and 80 to waitlist control. The investigators will conduct the pilot RCT and implement the PLP+SDOH. The participants randomized to PLP+SDOH will immediately receive the intervention by a trained CHW. Those randomized to control will receive nothing from us while the intervention arm is underway.
- Conditions
- Weight Loss Trial, Cardiometabolic Syndrome, Hypertension, Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus
- Being tested
- Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component
- Keywords
- Weight loss intervention, CHWs, Community Health Workers, PILI Lifestyle Program, Curriculum, Social Determinants of Health (SDoH), U.S. Pacific Jurisdictions, Continental U.S., Pacific, Hawai'i, Economic stability, Physical and Neighborhood Environment, Education, Food, Community and Social Context, Health Care System
- Medical subject headings
- Metabolic Syndrome, Hypertension, Dyslipidemias, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) ComponentBehavioural
The PILI Lifestyle Program (PLP) is an adapted 3-month behavioral lifestyle intervention focused on addressing and initiating weight loss in Native Hawaiians and Pacific Islanders (NHPIs). The PLP covers 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management across the 3 months. In this study, the PLP will be enhanced with social determinants of health (SDOH) components that address challenges such as access to healthy foods, housing, and employment issues. There will be 4 SDOH activities relevant to participants' needs and lives. These activities will be delivered during the 3-month PLP.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - PLP + SDoH | Experimental | 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. Receives: Behavioral: Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component |
| Waitlist Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Hemoglobin A1c data will be collected using the A1cNow+ kit.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Blood Cholesterol
Blood cholesterol measures will be obtained from a finger stick using the Cardiocheck Plus Analyzer. Total cholesterol, HDL, and LDL data will be collected.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Blood pressure
Systolic and diastolic blood pressure will be measured by a digital blood pressure monitor device.
Measured: Assessment data will be collected at baseline and 3-month follow up.
Height
Height data will be collected using a standardized portable stadiometer.
Measured: Assessment data are collected at baseline.
Weight
Weight will be calculated using a standardized mobile medical flat scale.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Secondary outcomes (12)
Dietary Questionnaire
A 5-item will be used to estimate the frequency and types of food a participant consumed in the past month. Taken directly from Common Survey IV, the dietary questionnaire consists of 5 items, documenting how many times per week in the past month participants have consumed specific types of food. The responses range from Never, 1-2 times per week, 3-4 times per week, 5-6 times per week, More than 6 times per week, and Don't know.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Brief Physical Activity Questionnaire
A 2-item physical activity questionnaire will be used to briefly assess average physical activity behavior per week and the duration of the physical activity.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Well-Being Questionnaire
A 6-item questionnaire used to briefly assess satisfaction of well-being in standard of living, health, past and present achievements in life, personal relationships, safety, and feeling of belonging.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Access to Health Care and Social Needs Form
A 9-item form to evaluate access to health care places, insurance plan, length of appointment time, confidence in filling out medical forms, transportation issues, neighborhood physical activity level, housing situation and food management.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Household Food Patterns Form
A 4-item questionnaire on household food patterns will be used to ask participants' household food patterns to assess the frequency of meal planning, using a shopping list, eating with other household members, and bringing prepared food home. The responses and scores range from 1- 1 day, 2- 2-3 days, 3- 4-5 days, 4- 6 days, 5- 7 days. Higher scores indicate greater household food patterns.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Food Literacy Form
An 11-item questionnaire on food literacy will be used to ask participants' food literacy in regard to planning, managing, selecting, preparing, and eating healthy foods. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4-slightly agree, 5-yes/always. Higher scores indicate greater food literacy.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Food Insecurity Form
A 19-item questionnaire on food insecurity will be used to measure household food supply. This form measures food security as high or marginal food security, low food security, and very low food security. Responses of "yes", "often true", "sometimes true", "every month", and "some months" are coded as affirmative. The higher the score, the lower the food security.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Nutrition Environment Form
A 2-item scale to assess access and availability of transportation to food locations and travel time via walking.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Social Cohesion Form
A 4-item form to assess social cohesion in the neighborhood environment. The items include question about willingness to help, harmony, trust, and shared values. The scoring is from 1 for strongly disagree, 3 for neutral, and 5 for strongly agree. A score is estimated by taking the average across all items within the scale. Higher score indicates greater social cohesion.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (PRAPARE) Risk Assessment Tool
The national standardized PRAPARE assessment tool will be used to ask participants' social drivers of health.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Information and Trust Questionnaire
A 10-item scale measuring perceptions of trust in resources to provide correct health information. The scoring ranges from Not at all, A little, A great deal, and Does not apply.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Social Connection and Isolation
To assess how often social and emotional support is received. Responses range from Always, Usually, Sometimes, Rarely, and Never.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Weight Loss TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial (RCT).
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Pasifika Organizations, Papa Ola Lōkahi, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Joseph K Kaholokula, PhD, Principal investigator, University of HawaiiSheri Daniels, PhD, Principal investigator, Papa Ola LokahiNia Aitaoto, PhD, Principal investigator, National Association of Pasifika Organizations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471595
- Sponsor's protocol ID
- Peau o le Vasa Phase 1
- Other IDs
- OT2HL158287
- Status last verified
- Dec 2024
- First submitted
- 17 Jun 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martiniuk AL, Lee CM, Lawes CM, Ueshima H, Suh I, Lam TH, Gu D, Feigin V, Jamrozik K, Ohkubo T, Woodward M; Asia-Pacific Cohort Studies Collaboration. Hypertension: its prevalence and population-attributable fraction for mortality from cardiovascular disease in the Asia-Pacific region. J Hypertens. 2007 Jan;25(1):73-9. doi: 10.1097/HJH.0b013e328010775f.
PubMed 17143176Aluli NE, Reyes PW, Brady SK, Tsark JU, Jones KL, Mau M, Howard WJ, Howard BV. All-cause and CVD mortality in Native Hawaiians. Diabetes Res Clin Pract. 2010 Jul;89(1):65-71. doi: 10.1016/j.diabres.2010.03.003. Epub 2010 Apr 14.
PubMed 20392507Waitzfelder B, Palaniappan L, Varga A, Frankland TB, Li J, Daida YG, Kaholokula JK, Bacong AM, Rawlings AM, Chung S, Howick C, Fortmann SP. Prevalence of cardiovascular disease among Asian, Pacific Islander and multi-race populations in Hawai'i and California. BMC Public Health. 2023 May 15;23(1):885. doi: 10.1186/s12889-023-15795-5.
PubMed 37189145Mau MK, West MR, Shara NM, Efird JT, Alimineti K, Saito E, Sugihara J, Ng R. Epidemiologic and clinical factors associated with chronic kidney disease among Asian Americans and Native Hawaiians. Ethn Health. 2007 Apr;12(2):111-27. doi: 10.1080/13557850601081720.
PubMed 17364897Palafox NA, Reichhardt M, Taitano JR, Nitta M, Garstang H, Riklon S, Taulung L, Buenconsejo-Lum LE. A Socio-Ecological Framework for Cancer Control in the Pacific: A Community Case Study of the US Affiliated Pacific Island Jurisdictions 1997-2017. Front Public Health. 2018 Nov 13;6:313. doi: 10.3389/fpubh.2018.00313. eCollection 2018.
PubMed 30483488Sentell TL, Ahn HJ, Juarez DT, Tseng CW, Chen JJ, Salvail FR, Miyamura J, Mau ML. Comparison of potentially preventable hospitalizations related to diabetes among Native Hawaiian, Chinese, Filipino, and Japanese elderly compared with whites, Hawai'i, December 2006-December 2010. Prev Chronic Dis. 2013 Jul 25;10:E123. doi: 10.5888/pcd10.120340.
PubMed 23886042Narcisse MR, Felix H, Long CR, Hudson T, Payakachat N, Bursac Z, McElfish PA. Frequency and predictors of health services use by Native Hawaiians and Pacific Islanders: evidence from the U.S. National Health Interview Survey. BMC Health Serv Res. 2018 Jul 21;18(1):575. doi: 10.1186/s12913-018-3368-3.
PubMed 30031403Orchard TJ, Temprosa M, Goldberg R, Haffner S, Ratner R, Marcovina S, Fowler S; Diabetes Prevention Program Research Group. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial. Ann Intern Med. 2005 Apr 19;142(8):611-9. doi: 10.7326/0003-4819-142-8-200504190-00009.
PubMed 15838067Wing RR, Hamman RF, Bray GA, Delahanty L, Edelstein SL, Hill JO, Horton ES, Hoskin MA, Kriska A, Lachin J, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner JG, Venditti B, Wylie-Rosett J; Diabetes Prevention Program Research Group. Achieving weight and activity goals among diabetes prevention program lifestyle participants. Obes Res. 2004 Sep;12(9):1426-34. doi: 10.1038/oby.2004.179.
PubMed 15483207Mau MK, Keawe'aimoku Kaholokula J, West MR, Leake A, Efird JT, Rose C, Palakiko DM, Yoshimura S, Kekauoha PB, Gomes H. Translating diabetes prevention into native Hawaiian and Pacific Islander communities: the PILI 'Ohana Pilot project. Prog Community Health Partnersh. 2010 Spring;4(1):7-16. doi: 10.1353/cpr.0.0111.
PubMed 20364073Nacapoy AH, Kaholokula JK, West MR, Dillard AY, Leake A, Kekauoha BP, Palakiko DM, Siu A, Mosier SW, Marjorie KM; PILI 'Ohana Project. Partnerships to address obesity disparities in Hawai'i: the PILI 'Ohana Project. Hawaii Med J. 2008 Sep;67(9):237-41.
PubMed 18853898Kaholokula JK, Wilson RE, Townsend CK, Zhang GX, Chen J, Yoshimura SR, Dillard A, Yokota JW, Palakiko DM, Gamiao S, Hughes CK, Kekauoha BK, Mau MK. Translating the Diabetes Prevention Program in Native Hawaiian and Pacific Islander communities: the PILI 'Ohana Project. Transl Behav Med. 2014 Jun;4(2):149-59. doi: 10.1007/s13142-013-0244-x.
PubMed 24904698Townsend CK, Miyamoto RE, Antonio M, Zhang G, Paloma D, Basques D, Braun KL, Kaholokula JK. The PILI@Work Program: a translation of the diabetes prevention program to Native Hawaiian-serving worksites in Hawai'i. Transl Behav Med. 2016 Jun;6(2):190-201. doi: 10.1007/s13142-015-0383-3.
PubMed 27356989Kristal AR, Beresford SA, Lazovich D. Assessing change in diet-intervention research. Am J Clin Nutr. 1994 Jan;59(1 Suppl):185S-189S. doi: 10.1093/ajcn/59.1.185S.
PubMed 8279421Marshall AL, Smith BJ, Bauman AE, Kaur S. Reliability and validity of a brief physical activity assessment for use by family doctors. Br J Sports Med. 2005 May;39(5):294-7; discussion 294-7. doi: 10.1136/bjsm.2004.013771.
PubMed 15849294
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peau o le Vasa: Accelerating the Currents of Health Equity for Pasifika People
- ClinicalTrials.gov ID
- NCT06471595
- Acronym / sponsor ID
- Peau o le Vasa Phase 1
- Conditions
- Weight Loss Trial, Cardiometabolic Syndrome, Hypertension, Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus
- Keywords
- Weight loss intervention, CHWs, Community Health Workers, PILI Lifestyle Program, Curriculum, Social Determinants of Health (SDoH), U.S. Pacific Jurisdictions, Continental U.S.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Association of Pasifika Organizations, Papa Ola Lōkahi, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our target populations are Native Hawaiians and Pacific Islanders (NHPIs) 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 (HTN), type 2 diabetes (T2D), and cardiovascular disease (CVD). 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 colonization of the Pacific and SDOH disadvantages led to the proliferation of sedentary lifestyles and calorie-dense, nutrient-poor foods (e.g., processed and fast foods) that were inexpensive, accessible, and have become part of the daily diet of many NHPIs and a big contributor to their chronic disease risk. NHPIs have higher rates of obesity, HTN, T2D, and CVD as well as chronic kidney disease, a consequence of HTN and T2D when compared to non-Hispanic Whites. NHPIs get many of these conditions at younger ages than non-Hispanic Whites and Asian Americans. They are more likely to be diagnosed with multiple chronic medical conditions and at later stages or greater severity, to be readmitted to the hospital, and to be frequent users of the emergency room and outpatient services. NHPIs have the lowest life expectancy (nearly ten years lower) compared to non-Hispanic Whites and Asian Americans.
To address the cardiometabolic health inequities in NHPIs, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was culturally and contextually adapted for them and called the PILI Lifestyle Program (PLP). Based on NHPI community engagement, the PLP consolidated the original 16 DPP-LI lessons into 8 lessons delivered over 3 months, with two additional community-identified topics added into these lessons (i.e., economically healthy eating and talking with participants' doctor). The lessons offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management. At each lesson, participants develop an individualized plan using SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) goals. The cultural adaptions included making food, exercise, and other lifestyle examples relevant to NHPIs. PLP was designed to be group-delivered (10-12 people) by a trained, community-based peer educator across different types of settings. Each lesson can be delivered between 1 hour and 1.5 hours, depending on the size of the group. The 3-month PLP has been found effective for improving weight loss, blood pressure, and physical activity frequency and functioning and reducing the consumption of dietary fat in overweight/obese NHPIs with co-morbid cardiometabolic conditions.
SDOH, defined as the conditions in which people are born, live, learn, work, play, and age, affect a person's ability to adopt and maintain healthier behaviors. SDOH are underlying drivers of unfair and avoidable differences in the risk for cardiometabolic-related conditions. They include income, food security, social norms, segregation, and language and literacy. NHPIs face many SDOH disadvantages that serve as barriers to accessing healthier lifestyles and quality healthcare. The 2020 U.S. Census shows 22.7% of NHPIs live below the federal poverty level and 9.1% were uninsured compared to 10.3% and 6.3% of non-Hispanic Whites, respectively. NHPIs are overrepresented as Supplemental Nutrition Assistance Program (SNAP) and Women Infants and Children (WIC) beneficiaries. Food insecurity is 3 times greater among NHPIs compared to non-Hispanic Whites. In terms of education attainment, only 24% of NHPIs have a college degree compared to 37% of students overall in the U.S. The investigators have already identified the major SDOH challenges faced by NHPIs, such as economic stability, physical and neighborhood environment, education, food, community and social context, and health care system. If adapted to address SDOH barriers, lifestyle interventions, like the PLP, can improve their long-term effects on adopting and maintaining healthier behaviors.
CHWs, serving as frontline public health workers and trusted community resources, can effectively disseminate and implement cardiometabolic-related interventions across different settings. The trusting relationship CHWs have with communities enables them to serve as a liaison, link, and intermediary between health and social services and the community to facilitate access to services and improve the quality and cultural and linguistic competence of these services. When it comes to addressing the health needs of NHPI communities, NHPI CHWs are uniquely positioned to deliver effective interventions to improve cardiometabolic health outcomes and their social determinants. Studies of NHPI CHWs have shown that they can effectively deliver interventions for primary and secondary prevention of cardiometabolic conditions among at-risk NHPIs. For example, they are effective in delivering culturally tailored lifestyle interventions to improve overweight/obesity, hemoglobin A1c (HbA1c) in those with T2D, and blood pressure control in those with uncontrolled HTN. The authors of a 2015 systemic review of Asian American and NHPI CHW programs concluded that CHWs from these communities serve an important role in improving outcomes for these underserved communities because they are uniquely positioned to provide culturally and linguistically tailored disease management strategies and peer support. They also found a need to increase efforts in documenting and evaluating core competency-based training of CHW in Asian American and NHPI communities.
Thus, this project will test the efficacy of a 3-month PLP + SDOH curriculum. the investigators will enhance the PLP by adding an SDOH component. Following is a list of the lessons and potential SDOH activities. However, the specific activity may vary based on the group's participants and the CHW.
PLP Lesson: The Benefits of Lifestyle Change; Setting Goals; Ways to Stay Motivated.
PLP Lesson: Being Active; Exercising Safely; Three Ways to Eat Less Fat. PLP Lesson: Get Moving; Tracking Progress; Being a Fat Detective (Finding Hidden Fats); Move Those Muscles.
PLP Lesson: Healthy Eating with the Plate Method; 3 Right Ways to Healthy Eating Out; Heart-Strengthening Activities.
SDOH activity: Accessing healthier foods-e.g., Visit by Land Grant program to develop home gardens or vegetable boxes for apartment dwellers.
PLP Lesson: Tip the Calorie Balance; Economics of Healthy Eating (Meal Planning).
SDOH activity: Job/Career - e.g., Support in job search and training. PLP Lesson: Of What's Around You (Battling Temptation); Make Social Cues Work for You.
SDOH activity: Housing - e.g., Visit by the local housing authority (low-income housing) on rental/deposit assistance for low earners, housing co-op, etc.
PLP Lesson: Problem-Solving Skills (Exploring Options); Talking with the Doctor (General Skills for Effective Communication).
SDOH activity: Legal-e.g., Visit by local legal aid to assist with immigration/migrant issues and legal support services.
PLP Lesson: Managing Negative Thoughts and Emotions; Controlling Stress; Review of Lessons.
Fifteen experienced CHWs from our network will deliver the PLP+SDOH to eligible NHPIs. 15 cohorts of 10-12 NHPI (n=160) participants ≥18 years of age with a self-reported cardiometabolic condition (i.e., pre-diabetes/type 2 diabetes, hypertension, dyslipidemia, and/or overweight/obesity [BMI ≥ 25]) will be enrolled and randomized to either the PLP+SDOH arm or to the waitlist control arm. In cohorts of 10-12 participants at each of the 15 community settings, a 1:1 randomization will be done immediately following baseline assessment so that 5-6 will be randomized to PLP+SDOH and 5-6 to waitlist control per cohort. Overall, 80 participants will be randomized to PLP+SDOH and 80 to waitlist control. The investigators will conduct the pilot RCT and implement the PLP+SDOH. The participants randomized to PLP+SDOH will immediately receive the intervention by a trained CHW. Those randomized to control will receive nothing from us while the intervention arm is underway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - PLP + SDoH | Experimental | Behavioral: Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) ComponentParticipants 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. |
| Waitlist Control Group | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NHPI participants over 18 years of age with a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])
Key exclusion criteria (1 listed)
- Not NHPI, NHPI participants under 18 years of age, and without a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) ComponentThe PILI Lifestyle Program (PLP) is an adapted 3-month behavioral lifestyle intervention focused on addressing and initiating weight loss in Native Hawaiians and Pacific Islanders (NHPIs). The PLP covers 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management across the 3 months. In this study, the PLP will be enhanced with social determinants of health (SDOH) components that address challenges such as access to healthy foods, housing, and employment issues. There will be 4 SDOH activities relevant to participants' needs and lives. These activities will be delivered during the 3-month PLP. | Behavioural | Intervention Group - PLP + SDoH |
Primary outcome
Hemoglobin A1c
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Hemoglobin A1c data will be collected using the A1cNow+ kit.
Blood Cholesterol
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Blood cholesterol measures will be obtained from a finger stick using the Cardiocheck Plus Analyzer. Total cholesterol, HDL, and LDL data will be collected.
Blood pressure
Time frame: Assessment data will be collected at baseline and 3-month follow up.
Systolic and diastolic blood pressure will be measured by a digital blood pressure monitor device.
Height
Time frame: Assessment data are collected at baseline.
Height data will be collected using a standardized portable stadiometer.
Weight
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Weight will be calculated using a standardized mobile medical flat scale.
12 secondary outcomes
Dietary Questionnaire
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Brief Physical Activity Questionnaire
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Well-Being Questionnaire
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Access to Health Care and Social Needs Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Household Food Patterns Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Food Literacy Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Food Insecurity Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Nutrition Environment Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Social Cohesion Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (PRAPARE) Risk Assessment Tool
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Information and Trust Questionnaire
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Social Connection and Isolation
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Background: PubMed 17143176Martiniuk AL, Lee CM, Lawes CM, Ueshima H, Suh I, Lam TH, Gu D, Feigin V, Jamrozik K, Ohkubo T, Woodward M; Asia-Pacific Cohort Studies Collaboration. Hypertension: its prevalence and population-attributable fraction for mortality from cardiovascular disease in the Asia-Pacific region. J Hypertens. 2007 Jan;25(1):73-9. doi: 10.1097/HJH.0b013e328010775f.
- Background: PubMed 20392507Aluli NE, Reyes PW, Brady SK, Tsark JU, Jones KL, Mau M, Howard WJ, Howard BV. All-cause and CVD mortality in Native Hawaiians. Diabetes Res Clin Pract. 2010 Jul;89(1):65-71. doi: 10.1016/j.diabres.2010.03.003. Epub 2010 Apr 14.
- Background: PubMed 37189145Waitzfelder B, Palaniappan L, Varga A, Frankland TB, Li J, Daida YG, Kaholokula JK, Bacong AM, Rawlings AM, Chung S, Howick C, Fortmann SP. Prevalence of cardiovascular disease among Asian, Pacific Islander and multi-race populations in Hawai'i and California. BMC Public Health. 2023 May 15;23(1):885. doi: 10.1186/s12889-023-15795-5.
- Background: PubMed 17364897Mau MK, West MR, Shara NM, Efird JT, Alimineti K, Saito E, Sugihara J, Ng R. Epidemiologic and clinical factors associated with chronic kidney disease among Asian Americans and Native Hawaiians. Ethn Health. 2007 Apr;12(2):111-27. doi: 10.1080/13557850601081720.
- Background: PubMed 30483488Palafox NA, Reichhardt M, Taitano JR, Nitta M, Garstang H, Riklon S, Taulung L, Buenconsejo-Lum LE. A Socio-Ecological Framework for Cancer Control in the Pacific: A Community Case Study of the US Affiliated Pacific Island Jurisdictions 1997-2017. Front Public Health. 2018 Nov 13;6:313. doi: 10.3389/fpubh.2018.00313. eCollection 2018.
- Background: PubMed 23886042Sentell TL, Ahn HJ, Juarez DT, Tseng CW, Chen JJ, Salvail FR, Miyamura J, Mau ML. Comparison of potentially preventable hospitalizations related to diabetes among Native Hawaiian, Chinese, Filipino, and Japanese elderly compared with whites, Hawai'i, December 2006-December 2010. Prev Chronic Dis. 2013 Jul 25;10:E123. doi: 10.5888/pcd10.120340.
- Background: PubMed 30031403Narcisse MR, Felix H, Long CR, Hudson T, Payakachat N, Bursac Z, McElfish PA. Frequency and predictors of health services use by Native Hawaiians and Pacific Islanders: evidence from the U.S. National Health Interview Survey. BMC Health Serv Res. 2018 Jul 21;18(1):575. doi: 10.1186/s12913-018-3368-3.
- Background: PubMed 15838067Orchard TJ, Temprosa M, Goldberg R, Haffner S, Ratner R, Marcovina S, Fowler S; Diabetes Prevention Program Research Group. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial. Ann Intern Med. 2005 Apr 19;142(8):611-9. doi: 10.7326/0003-4819-142-8-200504190-00009.
- Background: PubMed 15483207Wing RR, Hamman RF, Bray GA, Delahanty L, Edelstein SL, Hill JO, Horton ES, Hoskin MA, Kriska A, Lachin J, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner JG, Venditti B, Wylie-Rosett J; Diabetes Prevention Program Research Group. Achieving weight and activity goals among diabetes prevention program lifestyle participants. Obes Res. 2004 Sep;12(9):1426-34. doi: 10.1038/oby.2004.179.
- Background: PubMed 20364073Mau MK, Keawe'aimoku Kaholokula J, West MR, Leake A, Efird JT, Rose C, Palakiko DM, Yoshimura S, Kekauoha PB, Gomes H. Translating diabetes prevention into native Hawaiian and Pacific Islander communities: the PILI 'Ohana Pilot project. Prog Community Health Partnersh. 2010 Spring;4(1):7-16. doi: 10.1353/cpr.0.0111.
- Background: PubMed 18853898Nacapoy AH, Kaholokula JK, West MR, Dillard AY, Leake A, Kekauoha BP, Palakiko DM, Siu A, Mosier SW, Marjorie KM; PILI 'Ohana Project. Partnerships to address obesity disparities in Hawai'i: the PILI 'Ohana Project. Hawaii Med J. 2008 Sep;67(9):237-41.
- Background: PubMed 24904698Kaholokula JK, Wilson RE, Townsend CK, Zhang GX, Chen J, Yoshimura SR, Dillard A, Yokota JW, Palakiko DM, Gamiao S, Hughes CK, Kekauoha BK, Mau MK. Translating the Diabetes Prevention Program in Native Hawaiian and Pacific Islander communities: the PILI 'Ohana Project. Transl Behav Med. 2014 Jun;4(2):149-59. doi: 10.1007/s13142-013-0244-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component in people with Weight Loss Trial and Cardiometabolic Syndrome, run by University of Hawaii at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Assessment data will be collected at baseline and 3-month follow-up.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471595, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.