Diabetes Mellitus, Type 2NCT03270436
Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
A study testing Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program and Partnership for Improving Lifestyle Intervention Diabetes Prevention Program in people with Diabetes Mellitus, Type 2, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific Islander adapted intervention (Partnership for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program and Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 14 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Self reported Marshallese
- 18 years of age or older
- BMI greater than or equal to 25
Who cannot join
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger
- Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, an inability to finish the intervention, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).
Read the detailed description
Background and Rationale
Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.
The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (those living in the US and in the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes, more than all other racial/ethnic groups. Our pilot research, which includes health screenings with the Marshallese community in northwest Arkansas (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%). Our pilot data also revealed similar disparities in one of the strongest risk factors for diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese. Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further compounding these significant disparities in diabetes prevalence and related risk factors, research indicates that Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.
Reducing disparities by reducing weight. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can be clinically meaningful.
Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness, Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population using a cluster randomized controlled trial (cRCT).
Study design. The study design is a comparative effectiveness cRCT conducted in church settings or other community setting convenient to the participant group. Churches were selected as the primary setting based on Marshallese stakeholder input.
Randomized participant assignment. Randomization will occur at the church cluster level, with 1:1 assignment of churches to each arm. Churches and community based participant groups will be blocked (i.e., grouped into similar units) according to geographic region and approximate number of adult church members. Randomization will be conducted by a biostatistician or designated investigator, who will have no interactions with potential participants and has no supervisory role with study staff responsible for recruiting, consent, and intervention process.
Recruitment and Consent
Church-based recruitment is specified by stakeholders as culturally appropriate and the community's preferred recruitment method. During recruitment, Marshallese study staff will give presentations and distribute study information in English and Marshallese. Those who express interest will complete an eligibility screener, to determine eligibility. All study information and consent materials will be provided in English and/or Marshallese based upon the participants' preferences. Eligible participants will be provided a copy of the consent to review, and participants will have the opportunity to ask questions, consent, and enroll in the study. The consent process will include providing information to the potential participants and the opportunity to have bilingual Marshallese staff answer questions regarding study participation. The consent document will be given to the participant, and the informed consent process will be documented in the participant's research record.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program, Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention ProgramBehavioural
Faith based diabetes curriculum that teaches participants to connect faith and health.
Partnership for Improving Lifestyle Intervention Diabetes Prevention ProgramBehavioural
Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
| Study group | Role | What they receive |
|---|---|---|
| Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program | Experimental | The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log. Receives: Behavioral: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program |
| Partnership for Improving Lifestyle Intervention Diabetes Prevention Program | Experimental | The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis. Receives: Behavioral: Partnership for Improving Lifestyle Intervention Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Body Weight (kg)
Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Secondary outcomes (6)
Change in Mean HbA1c (%)
Change in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Change in Mean Systolic Blood Pressure (mmHg)
Change in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Change in Mean Diastolic Blood Pressure (mmHg)
Change in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Change in Sugar-sweetened Beverage Consumption
Change in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Change in Fruit and Vegetable Consumption
Change in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruits and vegetables.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (>4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099). Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and <4 = insufficient PA.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start8 Jan 2018
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two diabetes prevention program curricula in the Marshallese population.
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Pearl McElfish, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270436
- Sponsor's protocol ID
- 207034
- Status last verified
- Nov 2020
- First submitted
- 29 Aug 2017
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McElfish PA, Felix HC, Bursac Z, Rowland B, Yeary KHK, Long CR, Selig JP, Kaholokula JK, Riklon S. A Cluster Randomized Controlled Trial Comparing Diabetes Prevention Program Interventions for Overweight/Obese Marshallese Adults. Inquiry. 2023 Jan-Dec;60:469580231152051. doi: 10.1177/00469580231152051.
PubMed 36799349McElfish PA, Long CR, Kaholokula JK, Aitaoto N, Bursac Z, Capelle L, Laelan M, Bing WI, Riklon S, Rowland B, Ayers BL, Wilmoth RO, Langston KN, Schootman M, Selig JP, Yeary KHK. Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States. Medicine (Baltimore). 2018 May;97(19):e0677. doi: 10.1097/MD.0000000000010677.
PubMed 29742712
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
- ClinicalTrials.gov ID
- NCT03270436
- Acronym / sponsor ID
- 207034
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).
Detailed description
Background and Rationale
Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.
The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (those living in the US and in the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes, more than all other racial/ethnic groups. Our pilot research, which includes health screenings with the Marshallese community in northwest Arkansas (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%). Our pilot data also revealed similar disparities in one of the strongest risk factors for diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese. Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further compounding these significant disparities in diabetes prevalence and related risk factors, research indicates that Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.
Reducing disparities by reducing weight. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can be clinically meaningful.
Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness, Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population using a cluster randomized controlled trial (cRCT).
Study design. The study design is a comparative effectiveness cRCT conducted in church settings or other community setting convenient to the participant group. Churches were selected as the primary setting based on Marshallese stakeholder input.
Randomized participant assignment. Randomization will occur at the church cluster level, with 1:1 assignment of churches to each arm. Churches and community based participant groups will be blocked (i.e., grouped into similar units) according to geographic region and approximate number of adult church members. Randomization will be conducted by a biostatistician or designated investigator, who will have no interactions with potential participants and has no supervisory role with study staff responsible for recruiting, consent, and intervention process.
Recruitment and Consent
Church-based recruitment is specified by stakeholders as culturally appropriate and the community's preferred recruitment method. During recruitment, Marshallese study staff will give presentations and distribute study information in English and Marshallese. Those who express interest will complete an eligibility screener, to determine eligibility. All study information and consent materials will be provided in English and/or Marshallese based upon the participants' preferences. Eligible participants will be provided a copy of the consent to review, and participants will have the opportunity to ask questions, consent, and enroll in the study. The consent process will include providing information to the potential participants and the opportunity to have bilingual Marshallese staff answer questions regarding study participation. The consent document will be given to the participant, and the informed consent process will be documented in the participant's research record.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of two diabetes prevention program curricula in the Marshallese population.
| Arm | Type | Receives |
|---|---|---|
| Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program | Experimental | Behavioral: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention ProgramThe Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log. |
| Partnership for Improving Lifestyle Intervention Diabetes Prevention Program | Experimental | Behavioral: Partnership for Improving Lifestyle Intervention Diabetes Prevention ProgramThe Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self reported Marshallese
- 18 years of age or older
- BMI greater than or equal to 25
Key exclusion criteria (3 listed)
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger
- Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, an inability to finish the intervention, etc.
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 |
|---|---|---|
| Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention ProgramFaith based diabetes curriculum that teaches participants to connect faith and health. | Behavioural | Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program |
| Partnership for Improving Lifestyle Intervention Diabetes Prevention ProgramFamily and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight. | Behavioural | Partnership for Improving Lifestyle Intervention Diabetes Prevention Program |
Primary outcome
Change in Mean Body Weight (kg)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
6 secondary outcomes
Change in Mean HbA1c (%)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in Mean Systolic Blood Pressure (mmHg)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in Mean Diastolic Blood Pressure (mmHg)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in Sugar-sweetened Beverage Consumption
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in Fruit and Vegetable Consumption
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36799349McElfish PA, Felix HC, Bursac Z, Rowland B, Yeary KHK, Long CR, Selig JP, Kaholokula JK, Riklon S. A Cluster Randomized Controlled Trial Comparing Diabetes Prevention Program Interventions for Overweight/Obese Marshallese Adults. Inquiry. 2023 Jan-Dec;60:469580231152051. doi: 10.1177/00469580231152051.
- Derived from this study: PubMed 29742712McElfish PA, Long CR, Kaholokula JK, Aitaoto N, Bursac Z, Capelle L, Laelan M, Bing WI, Riklon S, Rowland B, Ayers BL, Wilmoth RO, Langston KN, Schootman M, Selig JP, Yeary KHK. Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States. Medicine (Baltimore). 2018 May;97(19):e0677. doi: 10.1097/MD.0000000000010677.
- Individual participant dataSharing planned: No
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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.
Pearl McElfish, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program and Partnership for Improving Lifestyle Intervention Diabetes Prevention Program in people with Diabetes Mellitus, Type 2, run by University of Arkansas at 1 site 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 3 inclusion and 3 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Body Weight (kg) (time frame: Baseline, immediate post-intervention, 6 months post-intervention). 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 NCT03270436, which also lists 2 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 9 Dec 2020.