Clinical trial NCT04755062: A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Blood Glucose, High
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: Change from baseline Fasting Glucose at week 13 and week 26
timeFrame: 26 weeks
measure: Change from baseline Fasting Insulin at week 13 and week 26
timeFrame: 26 weeks
measure: Change from baseline Blood lipids at week 13 and week 26
timeFrame: 26 weeks
measure: Change from baseline High sensitivity C-reactive protein (hsCRP) at week 13 and week 26
timeFrame: 26 weeks
measure: Change from baseline Insulin-like Growth Factor (IgF-1) at week 13 and week 26
timeFrame: 26 weeks
measure: Change from baseline systolic and diastolic blood pressure at week 13 and week 26
timeFrame: 26 weeks
Other outcomes:
measure: Change from baseline weight at week 13 and week 26
timeFrame: 26 weeks
measure: Height
timeFrame: Week 0
measure: Change from baseline diet at week 13 and week 26
timeFrame: 26 weeks
Locations:
city: Flagstaff
country: United States
facility: PRANDIAL Lab
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Nanette Lopez, PhD, MS/MS
role: PRINCIPAL_INVESTIGATOR
References: