Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755062
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-01-21
Brief Title:
A Culturally-relevant Micronutrient-dense Plant-rich mNDPR Dietary Intervention for Native Americans
Sponsor:
Northern Arizona University
Organization:
Northern Arizona University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None