CClinicalTrials.gg
WithdrawnNCT05470296Updated Nov 13, 2024

It's Native: Nudging Healthy Ways

An interventional study of Move & Eat 2 Live in Diet, Healthy and Physical Activity, sponsored by University of Southern Mississippi. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by University of Southern Mississippi · Not applicable, Interventional, and Prevention

Why this study was withdrawn
The study was disrupted by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diet, Healthy
  • Physical Activity

Keywords

  • Native American
  • nutrition
  • physical activity
03

In context

Lead sponsor

University of Southern Mississippi is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Move & Eat 2 Live

    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

  • 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.

    Also known as: ME2L

06

What researchers measure

Primary outcomes

  1. Added Sugar Intake

    Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome

    Time frame: Change from Baseline Added Sugar Intake at 3 months

  2. Red and Processed Meat Consumption

    Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome

    Time frame: Change from Baseline Red and Processed Meat Intake at 3 months

Secondary outcomes

  1. Physical Activity

    Metabolic Equivalent of Task (MET Minutes) scale from the International Physical Activity Questionnaire with higher scores indicating better outcome

    Time frame: Change from Baseline Physical Activity at 3 months

  2. Body Mass Index

    ratio of weight (kg) to height (m2)

    Time frame: Change from Baseline Body Mass Index at 3 months

Other outcomes

  1. Number of Participants who attend each session

    Calculated Attendance Rate of all 12 sessions

    Time frame: up to 12 weeks

  2. Retention

    Percent of sample that completed the program at 12 weeks compared to baseline

    Time frame: at 12 weeks

07

Study locations

1 site
  • The University of Southern Mississippi
    Hattiesburg, Mississippi 39406, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05470296
Lead sponsor
University of Southern Mississippi
Responsible party
Sponsor
First posted
Jul 22, 2022
Start date
Nov 1, 2024 (estimated)
Primary completion
Nov 30, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Nov 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion