It's Native: Nudging Healthy Ways

NCT05470296 | Withdrawn

• 1 other identifier: 22-880
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy; Physical Activity

Keywords

Native American; nutrition; physical activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Physical Activity

  Change from Baseline Physical Activity at 3 months

• Body Mass Index

  Change from Baseline Body Mass Index at 3 months

Other Outcomes (2)

• Number of Participants who attend each session

  up to 12 weeks

• Retention

  at 12 weeks

Study Arms (1)

Move & Eat 2 Live

OTHER

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

Behavioral: Move & Eat 2 Live

Interventions

Move & Eat 2 Live 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.

Also known as: ME2L

Move & Eat 2 Live

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead

Study Sites (1)

The University of Southern Mississippi

Hattiesburg, Mississippi, 39406, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-/post design

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 22, 2022
• Study Start: November 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)