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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 12-week eating program rich in plant foods, vitamins, and minerals can lower the risk of obesity and related diseases. It is for Native American employees of Twin Arrows Casino and includes weekly group coaching with materials that fit their culture. Participants are assigned by chance to start the program right away or after a 12-week wait.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Identify as Native American and work at Twin Arrows Casino.
  • Be 21 to 65 years old.
  • Report a body mass index (BMI) above 24. BMI is a measure based on height and weight.
  • Not be in a weight-loss program now.
  • Not take medicines that could raise medical risk, such as insulin, or have weight loss as a main side effect.
  • Have worked at Navajo Gaming Enterprise for one year before the study starts and plan to stay for the next year, through the study.

Who can't join

  • Have had weight-loss surgery: gastric bypass, an adjustable gastric band, gastric sleeve, or duodenal switch.
  • Are pregnant or plan to become pregnant within the next year.
  • Depend on insulin to control blood sugar.
  • Cannot attend weekly group coaching sessions.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

AZ