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mNDPR Diet for Obesity

N/A

Recruiting

Led By Nanette Lopez, PhD, MS/MS

Research Sponsored by Northern Arizona University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21-65 years of age

Be older than 18 years old

Must not have

Individuals reporting gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries

Insulin dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an intervention to reduce obesity & related disease risk in Native Americans at Twin Arrows Casino. Participants will receive 12 weeks of nutrition education & goals to follow, then be compared to a wait-list control.

Who is the study for?

This trial is for self-identified Native American employees of Twin Arrows Casino, aged 21-65 with a BMI over 24, not on weight-loss programs or certain medications. They must have worked there for at least a year and plan to stay another year but can't join if pregnant, planning pregnancy, had specific weight loss surgeries, or cannot attend weekly sessions.

What is being tested?

The study tests a culturally-tailored diet intervention aimed at reducing obesity risk among participants. It involves random assignment to either an immediate or wait-list group receiving the mNDPR nutrition protocol through weekly coaching sessions by trained students using Motivational Interviewing techniques.

What are the potential side effects?

As this is a nutritional intervention focusing on micronutrient-dense plant-rich foods rather than medication or surgery, significant side effects are not anticipated. However, changes in diet may cause temporary digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery, such as gastric bypass or sleeve.

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I rely on insulin for my diabetes management.

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I can attend weekly group coaching sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change from baseline Blood lipids at week 13 and week 26

Change from baseline Fasting Glucose at week 13 and week 26

Change from baseline Fasting Insulin at week 13 and week 26

+3 more

Other study objectives

Change from baseline diet at week 13 and week 26

Change from baseline weight at week 13 and week 26

Height

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Micronutrient-dense plant-rich InterventionExperimental Treatment1 Intervention

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.

Group II: Wait-list ControlActive Control1 Intervention

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.

0 / 4Eligibility criteria met