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It's Native: Nudging Healthy Ways

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05470296
Enrollment
0
Registered
2022-07-22
Start date
2024-11-01
Completion date
2024-11-30
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Physical Activity

Keywords

Native American, nutrition, physical activity

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.

Interventions

BEHAVIORALMove & 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.

Sponsors

University of Southern Mississippi
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Pre-/post design

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Added Sugar IntakeChange from Baseline Added Sugar Intake at 3 monthsScale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome
Red and Processed Meat ConsumptionChange from Baseline Red and Processed Meat Intake at 3 monthsScale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome

Secondary

MeasureTime frameDescription
Physical ActivityChange from Baseline Physical Activity at 3 monthsMetabolic Equivalent of Task (MET Minutes) scale from the International Physical Activity Questionnaire with higher scores indicating better outcome
Body Mass IndexChange from Baseline Body Mass Index at 3 monthsratio of weight (kg) to height (m2)

Other

MeasureTime frameDescription
Number of Participants who attend each sessionup to 12 weeksCalculated Attendance Rate of all 12 sessions
Retentionat 12 weeksPercent of sample that completed the program at 12 weeks compared to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026