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Dietary Intervention for Native Americans with Obesity and High Blood Sugar

This study is testing a special eating plan called the Micronutrient-dense Plant-rich (mNDPR) diet. This diet focuses on foods rich in vitamins, minerals, and plant-based nutrients. The goal is to see if this diet can help Native American employees of Twin Arrows Casino reduce their risk of obesity and related health problems like high blood sugar. You might be able to join if you are a Native American employee at Twin Arrows Casino, between 21 and 65 years old, have a body mass index (BMI) over 24 (which indicates overweight or obesity), and are not currently in a weight-loss program or taking certain medications. The main way we'll know if the diet is successful is by looking at changes in your Hemoglobin A1c (HgA1c), a measure of average blood sugar, after 13 and 26 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 146 participants. Participants will be randomly assigned to either receive the mNDPR diet intervention or be in a wait-list control group.
What's involved
If you are in the experimental group, you will receive a 12-week nutrition intervention with weekly group coaching sessions. These sessions will be led by trained lifestyle coaches at Twin Arrows Casino.
Compensation
Not stated in the trial record.
Follow-up
Your Hemoglobin A1c (HgA1c) will be measured at week 13 and again at week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04755062

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

Recruiting
NAAges 18+InterventionalPrevention
Northern Arizona University
~146 participants
Updated 2024-11-14 on ClinicalTrials.gov
What's tested:Micronutrient-dense plant-rich Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26
Measured over 26 weeks

Conditions

Obesity
Blood Glucose, High

Explore related trials

HyperglycemiaObesity

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

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

Who to contact

Nanette Lopez, PhD, MS/MS
[email protected]
928-523-7913
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 2626 weeks

    Analysis of plasma from fasting venous blood draws using one of the following methods: 1) HPLC, Cation-exchange HPLC, Boronate affinity chromatography, Capillary electrophoresis, Immunoassays, or Enzymatic methods.