It's Native: Nudging Healthy Ways

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470296
• Other study ID #: 22-880
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2022
• Source: University of Southern Mississippi
• Contact: Tammy Greer, PhD
• Phone: 6012666336
• Email: tammy.greer[@]usm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Southern Mississippi	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Mississippi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants who attend each session	Calculated Attendance Rate of all 12 sessions	up to 12 weeks
Other	Retention	Percent of sample that completed the program at 12 weeks compared to baseline	at 12 weeks
Primary	Added Sugar Intake	Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome	Change from Baseline Added Sugar Intake at 3 months
Primary	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	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
Secondary	Body Mass Index	ratio of weight (kg) to height (m2)	Change from Baseline Body Mass Index at 3 months