It's Native: Nudging Healthy Ways

Not Applicable

Withdrawn

• Conditions: Diet, Healthy; Physical Activity

• 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• Status: WITHDRAWN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

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