It's Native: Nudging Healthy Ways

Study Overview
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Brief Summary
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Native Americans suffer disproportionately from chronic diseases that may be prevented by achieving a healthy diet, physical activity and weight. For this pilot study, the aim is to examine the effectiveness and feasibility of a standard lifestyle management program implemented in community based settings among Native Americans.

Detailed Description
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A pilot study will be implemented to establish comparison data for the delivery of a standard lifestyle management program among Southeastern Native Americans. The program addresses the physical and intellectual domains. The ultimate goal will be to use focus group data and this pilot pre-post clinical trial to inform further cultural and social adaptations that could advance the effectiveness of lifestyle management programs in Southeastern Native Americans.

Official Title
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It's Native: Nudging Towards Healthy Ways in Southeastern American Indian Country

Conditions
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Diet, Healthy, Physical Activity

Intervention / Treatment
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* Behavioral: Move & Eat 2 Live


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not pregnant and more than 6 months postpartum Without complicated disease (ie. renal failure, cancer) Identify as Native American Resident of study area Adults 18-50 years Exclusion Criteria: Pregnant or within 6 months postpartum Complicated diseases states that are contraindications for the program goals Not Native American Not permanent resident of study area Less than 18 years of age or older than 50 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-/post design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Move & Eat 2 Live<br>12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight. | Behavioral: Move & Eat 2 Live<br>* American Indians suffer disproportionately from several chronic diseases that may be prevented with healthier modifiable factors. Nutrition, physical activity and a healthy weight are key factors that may prevent and reduce risk of disease incidence. The major goals of this project are to develop a culturally adapted intervention that addresses barriers and uses positive cultural values as guiding principles for behavior changes to enhance program retention and improve behaviors. This project will pilot a 12-week standard lifestyle intervention in American Indians.<br>* Other names: ME2L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Added Sugar Intake | Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome | Change from Baseline Added Sugar Intake at 3 months | 
| Red and Processed Meat Consumption | Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome | Change from Baseline Red and Processed Meat Intake at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Metabolic Equivalent of Task (MET Minutes) scale from the International Physical Activity Questionnaire with higher scores indicating better outcome | Change from Baseline Physical Activity at 3 months | 
| Body Mass Index | ratio of weight (kg) to height (m2) | Change from Baseline Body Mass Index at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Native American, nutrition, physical activity