Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04755062

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

Led by Northern Arizona University · Updated on 2024-11-14

146

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a culturally relevant micronutrient-dense plant-rich (mNDPR) dietary intervention designed to reduce obesity and related disease risks among Native American employees of Twin Arrows Casino. Native Americans face higher rates of obesity and Type II diabetes compared to non-Hispanic Whites. The study involves a randomized controlled trial to assess improvements in physical health measures, wellness, and healthcare costs over one year. Participants will be randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition program or a wait-list control group. The intervention includes a 2-hour initial group session followed by weekly 1-hour coaching sessions led by trained Native American Masters of Public Health students using Motivational Interviewing. Sessions provide nutrition education, cooking demonstrations, workplace dining tours, and social support. The wait-list control group will maintain usual eating habits during the first 12 weeks before receiving the same intervention. Participants will undergo health and wellness assessments at baseline and after 13 weeks, with additional diet recall at week 26 for the experimental group and follow-up measures for the control group. Healthcare utilization will be reviewed at 52 weeks. Researchers will measure changes in Hemoglobin A1c, fasting glucose, insulin, blood lipids, inflammatory markers, blood pressure, and wellness indicators like anxiety and sleep quality. Adherence to the diet will be monitored weekly, alongside attendance and self-monitoring of diet compliance.

CONDITIONS

Brief Title

A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identified Native American employee of Twin Arrows Casino
  • Aged 21 to 65 years
  • Self-reported body mass index (BMI) over 24 kg/m²
  • Not currently participating in a weight-loss program
  • Not taking medications that increase medical risk or cause weight loss
  • Employed at Navajo Gaming Enterprise for at least one year prior to study start and intend to remain employed during study period
Not Eligible

You will not qualify if you...

  • History of 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants in the experimental group attend a 2-hour initial group session followed by weekly 1-hour group sessions for 11 weeks with a trained Lifestyle Coach. They follow the micronutrient-dense plant-rich dietary protocol and self-monitor compliance. The wait-list control group maintains their usual diet during this period.

Weekly group visits for 12 weeks

Follow-up

Duration - Up to 40 weeks after treatment ends

Participants undergo follow-up assessments including diet analysis, health and wellness measures, and healthcare utilization data collection to evaluate the lasting effects of the intervention.

1 to 2 visits depending on group assignment

Trial Site Locations

Total: 1 location

1

PRANDIAL Lab

Flagstaff, Arizona, United States, 86011

Actively Recruiting

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Research Team

N

Nanette Lopez, PhD, MS/MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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