RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-01-18
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04755062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identified Native American employee of Twin Arrows Casino;
  2. * 21-65 years of age;
  3. * self-reported body mass index (BMI) of \>24 kg/m;
  4. * not currently participating in a weight-loss program;
  5. * not taking any medications that could increase medical risk (e.g., insulin) or that had weight loss as a primary side effect;
  6. * 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.
  1. * Individuals reporting gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries;
  2. * pregnancy, or planning to become pregnant within the next year;
  3. * insulin dependence;
  4. * inability to attend weekly group coaching sessions will be ineligible to participate.

Contacts and Locations

Study Contact

Nanette Lopez, PhD, MS/MS
CONTACT
928-523-7913
nanette.lopez@nau.edu

Principal Investigator

Nanette Lopez, PhD, MS/MS
PRINCIPAL_INVESTIGATOR
Northern Arizona University

Study Locations (Sites)

PRANDIAL Lab
Flagstaff, Arizona, 86011
United States

Collaborators and Investigators

Sponsor: Northern Arizona University

  • Nanette Lopez, PhD, MS/MS, PRINCIPAL_INVESTIGATOR, Northern Arizona University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-18
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-01-18
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Blood Glucose, High