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

ConditionsObesity Blood Glucose, High

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNorthern Arizona University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

146 Participants

are divided into 2 treatment groups

Group A: Micronutrient-dense plant-rich InterventionExperimental treatment 1 intervention

Group B: Wait-list ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

26 weeks

Secondary outcomes

Change from baseline Fasting Glucose at week 13 and week 26

Analysis of plasma from fasting venous blood draws using standardized enzymatic methods.

Time frame

26 weeks

Change from baseline Fasting Insulin at week 13 and week 26

Analysis of serum from fasting venous blood draws using insulin radioimmunoassay methods.

Time frame

26 weeks

Change from baseline Blood lipids at week 13 and week 26

Analysis of plasma from fasting venous blood draws using standardized, automated, high throughput, enzymatic analyses.

Time frame

26 weeks

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

Analysis of plasma from fasting venous blood draws using ELISA, immunoturbidimetry, time-resolved immunofluorimetric assay, or mass spectometry.

Time frame

26 weeks

Other outcomes

Change from baseline weight at week 13 and week 26

Weight will be measured in duplicate using a SECA 813 digital scale, with measurement from 0-440lb (200kg), with higher numbers representing higher weight (worse outcome)

Time frame

26 weeks

Height

Height will be measured in duplicate using a stadiometer.

Time frame

Week 0

Change from baseline diet at week 13 and week 26

The ASA 24-hour dietary assessment tool will be used to measure diet. This is not a single scale, rather the data determine multiple dietary variables including fruit and vegetables, whole grains, and dietary fats.

Time frame

26 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northern Arizona University

Lead sponsor

Source ClinicalTrials.gov

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