NCT04755062 A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
| NCT ID | NCT04755062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northern Arizona University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2023-01-18 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Nanette Lopez, PhD, MS/MS
PRINCIPAL INVESTIGATOR
Northern Arizona University
Frequently Asked Questions
Who can join the NCT04755062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04755062 currently recruiting?
Yes, NCT04755062 is actively recruiting participants. Contact the research team at nanette.lopez@nau.edu for enrollment information.
Where is the NCT04755062 trial being conducted?
This trial is being conducted at Flagstaff, United States.
Who is sponsoring the NCT04755062 clinical trial?
NCT04755062 is sponsored by Northern Arizona University. The principal investigator is Nanette Lopez, PhD, MS/MS at Northern Arizona University. The trial plans to enroll 146 participants.
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