Diet, HealthyNCT05470296
It's Native: Nudging Healthy Ways
A study testing Move & Eat 2 Live in people with Diet, Healthy and Physical Activity, run by University of Southern Mississippi at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Physical Activity
- What is being tested?
- Move & Eat 2 Live
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Southern Mississippi
Hattiesburg, Mississippi, 39406
About this study
Official title: It's Native: Nudging Towards Healthy Ways in Southeastern American Indian Country
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.
- Conditions
- Diet, Healthy, Physical Activity
- Being tested
- Move & Eat 2 Live
- Keywords
- Native American, nutrition, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move & Eat 2 LiveBehavioural
Also called ME2L
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.
| Study group | Role | What they receive |
|---|---|---|
| Move & Eat 2 Live | Other | 12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight. Receives: Behavioral: Move & Eat 2 Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Added Sugar Intake
Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome
Measured: 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
Measured: Change from Baseline Red and Processed Meat Intake at 3 months
Secondary outcomes (2)
Physical Activity
Metabolic Equivalent of Task (MET Minutes) scale from the International Physical Activity Questionnaire with higher scores indicating better outcome
Measured: Change from Baseline Physical Activity at 3 months
Body Mass Index
ratio of weight (kg) to height (m2)
Measured: Change from Baseline Body Mass Index at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Nov 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Why it stopped: The study was disrupted by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-/post design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470296
- Sponsor's protocol ID
- 22-880
- Status last verified
- Nov 2024
- First submitted
- 15 Jul 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It's Native: Nudging Towards Healthy Ways in Southeastern American Indian Country
- ClinicalTrials.gov ID
- NCT05470296
- Acronym / sponsor ID
- 22-880
- Conditions
- Diet, Healthy, Physical Activity
- Keywords
- Native American, nutrition, physical activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was disrupted by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-/post design
| Arm | Type | Receives |
|---|---|---|
| Move & Eat 2 Live | Other | Behavioral: Move & Eat 2 Live12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Move & Eat 2 LiveAlso: ME2LAmerican 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. | Behavioural | Move & Eat 2 Live |
Primary outcome
Added Sugar Intake
Time frame: Change from Baseline Added Sugar Intake at 3 months
Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome
Red and Processed Meat Consumption
Time frame: Change from Baseline Red and Processed Meat Intake at 3 months
Scale from NHANES Dietary Screener Questionnaire with higher scores meaning worse outcome
2 secondary outcomes
Physical Activity
Time frame: Change from Baseline Physical Activity at 3 months
Body Mass Index
Time frame: Change from Baseline Body Mass Index at 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Move & Eat 2 Live in people with Diet, Healthy and Physical Activity, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Added Sugar Intake (time frame: Change from Baseline Added Sugar Intake at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.