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

NCT04755062 | Recruiting

• 1 other identifier: 1R15MD015381-01A1
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Blood Glucose, High

Outcome Measures

Primary Outcomes (1)

• Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26

  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.

  26 weeks

Secondary Outcomes (6)

• Change from baseline Fasting Glucose at week 13 and week 26

  26 weeks

• Change from baseline Fasting Insulin at week 13 and week 26

  26 weeks

• Change from baseline Blood lipids at week 13 and week 26

  26 weeks

• Change from baseline High sensitivity C-reactive protein (hsCRP) at week 13 and week 26

  26 weeks

• Change from baseline Insulin-like Growth Factor (IgF-1) at week 13 and week 26

  26 weeks

Other Outcomes (3)

• Change from baseline weight at week 13 and week 26

  26 weeks

• Height

  Week 0

• Change from baseline diet at week 13 and week 26

  26 weeks

Study Arms (2)

Micronutrient-dense plant-rich Intervention

EXPERIMENTAL

The intervention will consist of a 2-hour 'immersion' group session, followed by weekly 1-hour group sessions over the following 11 weeks. Groups of no more than 15 individuals will meet weekly for 12 weeks with a trained Lifestyle Coach. Group sessions, held at the Twin Arrows Casino, will provide participants with instructions, assistance with goal setting, support, encouragement, cooking demonstrations, Casino (workplace) dining tours, and will socially engage with other participants. Participants will be requested to follow the mNDPR nutrition protocol for the first 12 weeks. Each week the participants will use a simple tracking method to self-monitor their daily compliance with the nutrition protocol. Lifestyle Coaches will monitor adherence and verify attendance. Instructional materials discussed each week will provide resources and methods to overcome common barriers to dietary change including (i) meal prepping, (ii) social gatherings, and (iii) family resistance.

Behavioral: Micronutrient-dense plant-rich Intervention

Wait-list Control

ACTIVE COMPARATOR

Participants in the wait-list control group will be requested to maintain their typical eating patterns during a 12-week waiting period, until they are scheduled to start the intervention 13-weeks later.

Behavioral: Micronutrient-dense plant-rich Intervention

Interventions

Micronutrient-dense plant-rich Intervention BEHAVIORAL

The mNDPR dietary protocol is designed to be (1) micronutrient rich (i.e., high in plant-derived phytochemicals, antioxidants, vitamins, and minerals); (2) nutritionally adequate and diverse; (3) hormonally favorable, avoiding carbohydrates with a high glycemic index that could elevate levels of serum insulin and minimizing animal protein that may invoke an inflammatory response; and (4) encourage intake of regular meals, limited consumption of snacks, and an overnight "fast" of at least 12 hours. The calorie breakdown of the diet is derived from approximately: 30-60% vegetables, 10-40% beans/legumes, 10-40% fruit, 10-40% seeds/nuts, 20% whole grains, no more than 10% naturally raised and wild animal products, poultry, eggs, fish, dairy, oil and white potatoes.

Also known as: mNDPR intervention

Micronutrient-dense plant-rich Intervention; Wait-list Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified Native American employee of Twin Arrows Casino;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

PRANDIAL Lab

Flagstaff, Arizona, 86011, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nanette Lopez, PhD, MS/MS

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nanette Lopez, PhD, MS/MS

CONTACT

928-523-7913; nanette.lopez@nau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 15, 2021
• Study Start: January 18, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)