It's Native: Nudging Healthy Ways

NCT ID: NCT05470296

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2024-11-30

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.

Conditions

Diet, Healthy; Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Move & Eat 2 Live

12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.

Group Type: OTHER

Move & Eat 2 Live

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ME2L

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern Mississippi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Southern Mississippi

Hattiesburg, Mississippi, United States

Countries

United States

Other Identifiers

22-880

Identifier Type: -

Identifier Source: org_study_id