It's Native: Nudging Healthy Ways

Not Applicable

Withdrawn

• Conditions: Diet, Healthy; Physical Activity
• Interventions: Behavioral: Move & Eat 2 Live

• Registration Number: NCT05470296
• Lead Sponsor: University of Southern Mississippi

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Added Sugar Intake	Change from Baseline Added Sugar Intake at 3 months	Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome
Red and Processed Meat Consumption	Change from Baseline Red and Processed Meat Intake at 3 months	Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Southern Mississippi; 🇺🇸 Hattiesburg, Mississippi, United States