Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04755062

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

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

146

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Age between 21 and 65 years
  • Self-reported body mass index (BMI) greater than 24 kg/m
  • Not currently participating in a weight-loss program
  • Not taking medications that increase medical risk or cause weight loss as a primary side effect
  • Employed at Navajo Gaming Enterprise for at least one year prior to study and intend to continue working there during the study
Not Eligible

You will not qualify if you...

  • History of gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries
  • Pregnant 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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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

CONTACT

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