It's Native: Nudging Healthy Ways

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Physical Activity; Diet, Healthy
• Intervention / Treatment: Behavioral: Move & Eat 2 Live

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39406
      • The University of Southern Mississippi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Move & Eat 2 Live; 12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.

Behavioral: Move & Eat 2 Live; 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.; Other Names: ME2L

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who attend each session	Calculated Attendance Rate of all 12 sessions	up to 12 weeks
Retention	Percent of sample that completed the program at 12 weeks compared to baseline	at 12 weeks

Collaborators and Investigators

• Sponsor: University of Southern Mississippi

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; nutrition; Native American
• Other Study ID Numbers: 22-880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No