ObesityNCT04755062
A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
A study testing Micronutrient-dense plant-rich Intervention in people with Obesity and Blood Glucose, High, run by Northern Arizona University at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Blood Glucose, High
- What is being tested?
- Micronutrient-dense plant-rich Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Native American employee of Twin Arrows Casino;
- 21-65 years of age;
- self-reported body mass index (BMI) of >24 kg/m;
- not currently participating in a weight-loss program;
- not taking any medications that could increase medical risk (e.g., insulin) or that had weight loss as a primary side effect;
- must work at Navajo Gaming Enterprise one year prior to the start of the study and indicate intent to work at Navajo Gaming Enterprise over the following year through the length of the study.
Who cannot join
- Individuals reporting gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries;
- pregnancy, or planning to become pregnant within the next year;
- insulin dependence;
- inability to attend weekly group coaching sessions will be ineligible to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PRANDIAL Lab
Flagstaff, Arizona, 86011
Nanette Lopez, PhD, MS/MS, 928-523-7913, nanette.lopez@nau.edu
About this study
Official title: Reduction of Risk Factors for Obesity and Linked Chronic Diseases in Native American Employees of the Twin Arrows Casino Through a Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention
The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. The experimental group will receive a 12-week mNDPR nutrition intervention with culturally relevant materials. Five NAU Masters of Public Health (MPH) students will be trained in Motivational Interviewing and the mNDPR nutrition protocol to serve as Lifestyle Coaches. These students will lead weekly, group-based coaching sessions with up to 15 participants each at Twin Arrows Casino. Participants will be assigned to their designated group based on their availability. The 12 weekly group sessions will be scheduled to accommodate various work shifts (day, night, and swing). The first group session will be 2-hours long to serve as an 'immersion', followed by weekly 1-hour sessions, all led by the Lifestyle Coaches. The Lifestyle Coaches will use Motivational Interviewing techniques to assist participants to develop personal goals. Lifestyle Coaches will also provide nutrition education, specifically using the mNDPR protocol. Participants in the wait-list control will receive the same intervention after the experimental group completes their 12-week intervention. In addition to measures at weeks 0 and 13, a 24-hour diet recall will be conducted in week 26 for the experimental group to explore long-term durability of diet quality changes.
Read the detailed description
Native Americans are 50% more likely to be obese compared with non-Hispanic Whites and are twice as likely to be diagnosed with diabetes. Obesity and poor diet quality are major risk factors for developing Type II diabetes, and Native Americans are disproportionately impacted by poor physical health outcomes. The investigators propose to develop a culturally-relevant micronutrient-dense plant-rich (mNDPR) dietary protocol, which will then be used in a pilot, randomized-controlled trial (RCT) to test the effectiveness of improving health and wellness of Native American employees of Twin Arrows Casino. This study will train and employ Native American students of Northern Arizona University (NAU) to implement the protocol and serve as Lifestyle coaches for the intervention. It is hypothesized that the protocol will be effective in (i) improving anthropometric measures (weight, waist circumference), cardiometabolic measures (cholesterol, triglycerides, blood glucose, hemoglobin A1c (HbA1c), fasting insulin, hsCRP, IgF-1, and blood pressure), and wellness measures (anxiety, stress, sleep quality, depressive symptoms, and mood); and (ii) reducing healthcare costs in Native American employees of Twin Arrows Casino over a 1- year period. Consistent with the specified aims of the National Institute on Minority Health and Health Disparities, this project will address health and wellness issues in an underserved population that is disproportionately affected by obesity and related diseases. Consistent with the specified objectives of the Academic Enhancement Research Award, this project will significantly increase research opportunities for students in the Health Sciences, providing the expertise and experience needed to develop skills and advance their careers. Employees of the Twin Arrows Casino will be randomly assigned to a 12-week in-person experimental group or a wait-list control group that will be assigned a start-date 12 weeks after the experimental group. Both groups will undergo the same measures of health and wellness at study week 0 (baseline) and week 13 (post-intervention for the experimental group). During week 26, the experimental group will undergo follow-up diet analysis and the wait-list control will undergo all measures of health and wellness. Healthcare utilization data will be collected at week 52 for both groups. Statistically significant differences between the intervention and control at the end of the first 12 weeks, as well as differences between baseline and post-intervention outcomes for both groups, will demonstrate the effectiveness of this program in reducing risk factors for obesity and related diseases in Native American employees. Health-care costs of both groups will also be evaluated and significant differences will suggest cost-effectiveness of the program.
- Conditions
- Obesity, Blood Glucose, High
- Being tested
- Micronutrient-dense plant-rich Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient-dense plant-rich InterventionBehavioural
Also called mNDPR intervention
The mNDPR dietary protocol is designed to be (1) micronutrient rich (i.e., high in plant-derived phytochemicals, antioxidants, vitamins, and minerals); (2) nutritionally adequate and diverse; (3) hormonally favorable, avoiding carbohydrates with a high glycemic index that could elevate levels of serum insulin and minimizing animal protein that may invoke an inflammatory response; and (4) encourage intake of regular meals, limited consumption of snacks, and an overnight "fast" of at least 12 hours. The calorie breakdown of the diet is derived from approximately: 30-60% vegetables, 10-40% beans/legumes, 10-40% fruit, 10-40% seeds/nuts, 20% whole grains, no more than 10% naturally raised and wild animal products, poultry, eggs, fish, dairy, oil and white potatoes.
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient-dense plant-rich Intervention | Experimental | The intervention will consist of a 2-hour 'immersion' group session, followed by weekly 1-hour group sessions over the following 11 weeks. Groups of no more than 15 individuals will meet weekly for 12 weeks with a trained Lifestyle Coach. Group sessions, held at the Twin Arrows Casino, will provide participants with instructions, assistance with goal setting, support, encouragement, cooking demonstrations, Casino (workplace) dining tours, and will socially engage with other participants. Participants will be requested to follow the mNDPR nutrition protocol for the first 12 weeks. Each week the participants will use a simple tracking method to self-monitor their daily compliance with the nutrition protocol. Lifestyle Coaches will monitor adherence and verify attendance. Instructional materials discussed each week will provide resources and methods to overcome common barriers to dietary change including (i) meal prepping, (ii) social gatherings, and (iii) family resistance. Receives: Behavioral: Micronutrient-dense plant-rich Intervention |
| Wait-list Control | Active comparator | Participants in the wait-list control group will be requested to maintain their typical eating patterns during a 12-week waiting period, until they are scheduled to start the intervention 13-weeks later. Receives: Behavioral: Micronutrient-dense plant-rich Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26
Analysis of plasma from fasting venous blood draws using one of the following methods: 1) HPLC, Cation-exchange HPLC, Boronate affinity chromatography, Capillary electrophoresis, Immunoassays, or Enzymatic methods.
Measured: 26 weeks
Secondary outcomes (6)
Change from baseline Fasting Glucose at week 13 and week 26
Analysis of plasma from fasting venous blood draws using standardized enzymatic methods.
Measured: 26 weeks
Change from baseline Fasting Insulin at week 13 and week 26
Analysis of serum from fasting venous blood draws using insulin radioimmunoassay methods.
Measured: 26 weeks
Change from baseline Blood lipids at week 13 and week 26
Analysis of plasma from fasting venous blood draws using standardized, automated, high throughput, enzymatic analyses.
Measured: 26 weeks
Change from baseline High sensitivity C-reactive protein (hsCRP) at week 13 and week 26
Analysis of plasma from fasting venous blood draws using ELISA, immunoturbidimetry, time-resolved immunofluorimetric assay, or mass spectometry.
Measured: 26 weeks
Change from baseline Insulin-like Growth Factor (IgF-1) at week 13 and week 26
Analysis of plasma from fasting venous blood draws using immunoassay, mass spectrometry, liquid chromatography tandem mass spectometry, or liquid chromatography high resolution accurate-mass mass spectrometry.
Measured: 26 weeks
Change from baseline systolic and diastolic blood pressure at week 13 and week 26
Auscultation method will be used to determine Korotkoff sounds over multiple blood pressure readings that will be averaged at each assessment. At each measurement point (weeks 0, 13, and 26), measurement staff will take blood pressure four times, twice on the first day of testing and twice on the second day.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start18 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanette Lopez, PhD, MS/MS, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755062
- Sponsor's protocol ID
- 1R15MD015381-01A1
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only non-identifiable, group-based data would be shared with other researchers beyond those investigators working on the project.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Risk Factors for Obesity and Linked Chronic Diseases in Native American Employees of the Twin Arrows Casino Through a Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention
- ClinicalTrials.gov ID
- NCT04755062
- Acronym / sponsor ID
- 1R15MD015381-01A1
- Conditions
- Obesity, Blood Glucose, High
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Feb 2021 (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.
The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. The experimental group will receive a 12-week mNDPR nutrition intervention with culturally relevant materials. Five NAU Masters of Public Health (MPH) students will be trained in Motivational Interviewing and the mNDPR nutrition protocol to serve as Lifestyle Coaches. These students will lead weekly, group-based coaching sessions with up to 15 participants each at Twin Arrows Casino. Participants will be assigned to their designated group based on their availability. The 12 weekly group sessions will be scheduled to accommodate various work shifts (day, night, and swing). The first group session will be 2-hours long to serve as an 'immersion', followed by weekly 1-hour sessions, all led by the Lifestyle Coaches. The Lifestyle Coaches will use Motivational Interviewing techniques to assist participants to develop personal goals. Lifestyle Coaches will also provide nutrition education, specifically using the mNDPR protocol. Participants in the wait-list control will receive the same intervention after the experimental group completes their 12-week intervention. In addition to measures at weeks 0 and 13, a 24-hour diet recall will be conducted in week 26 for the experimental group to explore long-term durability of diet quality changes.
Detailed description
Native Americans are 50% more likely to be obese compared with non-Hispanic Whites and are twice as likely to be diagnosed with diabetes. Obesity and poor diet quality are major risk factors for developing Type II diabetes, and Native Americans are disproportionately impacted by poor physical health outcomes. The investigators propose to develop a culturally-relevant micronutrient-dense plant-rich (mNDPR) dietary protocol, which will then be used in a pilot, randomized-controlled trial (RCT) to test the effectiveness of improving health and wellness of Native American employees of Twin Arrows Casino. This study will train and employ Native American students of Northern Arizona University (NAU) to implement the protocol and serve as Lifestyle coaches for the intervention. It is hypothesized that the protocol will be effective in (i) improving anthropometric measures (weight, waist circumference), cardiometabolic measures (cholesterol, triglycerides, blood glucose, hemoglobin A1c (HbA1c), fasting insulin, hsCRP, IgF-1, and blood pressure), and wellness measures (anxiety, stress, sleep quality, depressive symptoms, and mood); and (ii) reducing healthcare costs in Native American employees of Twin Arrows Casino over a 1- year period. Consistent with the specified aims of the National Institute on Minority Health and Health Disparities, this project will address health and wellness issues in an underserved population that is disproportionately affected by obesity and related diseases. Consistent with the specified objectives of the Academic Enhancement Research Award, this project will significantly increase research opportunities for students in the Health Sciences, providing the expertise and experience needed to develop skills and advance their careers. Employees of the Twin Arrows Casino will be randomly assigned to a 12-week in-person experimental group or a wait-list control group that will be assigned a start-date 12 weeks after the experimental group. Both groups will undergo the same measures of health and wellness at study week 0 (baseline) and week 13 (post-intervention for the experimental group). During week 26, the experimental group will undergo follow-up diet analysis and the wait-list control will undergo all measures of health and wellness. Healthcare utilization data will be collected at week 52 for both groups. Statistically significant differences between the intervention and control at the end of the first 12 weeks, as well as differences between baseline and post-intervention outcomes for both groups, will demonstrate the effectiveness of this program in reducing risk factors for obesity and related diseases in Native American employees. Health-care costs of both groups will also be evaluated and significant differences will suggest cost-effectiveness of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronutrient-dense plant-rich Intervention | Experimental | Behavioral: Micronutrient-dense plant-rich InterventionThe intervention will consist of a 2-hour 'immersion' group session, followed by weekly 1-hour group sessions over the following 11 weeks. Groups of no more than 15 individuals will meet weekly for 12 weeks with a trained Lifestyle Coach. Group sessions, held at the Twin Arrows Casino, will provide participants with instructions, assistance with goal setting, support, encouragement, cooking demonstrations, Casino (workplace) dining tours, and will socially engage with other participants. Participants will be requested to follow the mNDPR nutrition protocol for the first 12 weeks. Each week the participants will use a simple tracking method to self-monitor their daily compliance with the nutrition protocol. Lifestyle Coaches will monitor adherence and verify attendance. Instructional materials discussed each week will provide resources and methods to overcome common barriers to dietary change including (i) meal prepping, (ii) social gatherings, and (iii) family resistance. |
| Wait-list Control | Active comparator | Behavioral: Micronutrient-dense plant-rich InterventionParticipants in the wait-list control group will be requested to maintain their typical eating patterns during a 12-week waiting period, until they are scheduled to start the intervention 13-weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identified Native American employee of Twin Arrows Casino;
- 21-65 years of age;
- self-reported body mass index (BMI) of >24 kg/m;
- not currently participating in a weight-loss program;
- not taking any medications that could increase medical risk (e.g., insulin) or that had weight loss as a primary side effect;
Key exclusion criteria (4 listed)
- Individuals reporting gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries;
- pregnancy, or planning to become pregnant within the next year;
- insulin dependence;
- inability to attend weekly group coaching sessions will be ineligible to participate.
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 |
|---|---|---|
| Micronutrient-dense plant-rich InterventionAlso: mNDPR interventionThe mNDPR dietary protocol is designed to be (1) micronutrient rich (i.e., high in plant-derived phytochemicals, antioxidants, vitamins, and minerals); (2) nutritionally adequate and diverse; (3) hormonally favorable, avoiding carbohydrates with a high glycemic index that could elevate levels of serum insulin and minimizing animal protein that may invoke an inflammatory response; and (4) encourage intake of regular meals, limited consumption of snacks, and an overnight "fast" of at least 12 hours. The calorie breakdown of the diet is derived from approximately: 30-60% vegetables, 10-40% beans/legumes, 10-40% fruit, 10-40% seeds/nuts, 20% whole grains, no more than 10% naturally raised and wild animal products, poultry, eggs, fish, dairy, oil and white potatoes. | Behavioural | Micronutrient-dense plant-rich Intervention, Wait-list Control |
Primary outcome
Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26
Time frame: 26 weeks
Analysis of plasma from fasting venous blood draws using one of the following methods: 1) HPLC, Cation-exchange HPLC, Boronate affinity chromatography, Capillary electrophoresis, Immunoassays, or Enzymatic methods.
6 secondary outcomes
Change from baseline Fasting Glucose at week 13 and week 26
Time frame: 26 weeks
Change from baseline Fasting Insulin at week 13 and week 26
Time frame: 26 weeks
Change from baseline Blood lipids at week 13 and week 26
Time frame: 26 weeks
Change from baseline High sensitivity C-reactive protein (hsCRP) at week 13 and week 26
Time frame: 26 weeks
Change from baseline Insulin-like Growth Factor (IgF-1) at week 13 and week 26
Time frame: 26 weeks
Change from baseline systolic and diastolic blood pressure at week 13 and week 26
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No. Only non-identifiable, group-based data would be shared with other researchers beyond those investigators working on the project.
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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.
Nanette Lopez, PhD, MS/MS principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrient-dense plant-rich Intervention in people with Obesity and Blood Glucose, High, run by Northern Arizona University 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanette Lopez, PhD, MS/MS (928-523-7913, nanette.lopez@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26 (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2024.