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The study was disrupted by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Move & Eat 2 Live | Other | 12, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Metabolic Equivalent of Task (MET Minutes) scale from the International Physical Activity Questionnaire with higher scores indicating better outcome | Change from Baseline Physical Activity at 3 months |
| Body Mass Index |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who attend each session | Calculated Attendance Rate of all 12 sessions | up to 12 weeks |
| Retention | Percent of sample that completed the program at 12 weeks compared to baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Southern Mississippi | Hattiesburg | Mississippi | 39406 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Pre-/post design
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ratio of weight (kg) to height (m2)
| Change from Baseline Body Mass Index at 3 months |
| at 12 weeks |