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The Okla Achokma Project

University of Southern Mississippi logo

University of Southern Mississippi

Status

Completed

Conditions

Healthy
Physical Activity
Diet

Treatments

Behavioral: Behavioral Treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06633939
1R56HL164335-01A1 (U.S. NIH Grant/Contract)
22-880-08

Details and patient eligibility

About

Deep South Native Americans disparately suffer from diabetes, hypertension, and obesity with only 5-10% of Native Americans living past age 65 compared to 15-17% of Whites. Standard lifestyle interventions to improve diet and physical activity behaviors have shown improvement in weight and other cardiometabolic outcomes among Native Americans. The impact of lifestyle interventions on preventable chronic diseases among Native Americans is limited by the exclusion of a multi-level approach with cultural and social enhancements that address the spiritual and social domains of physical health. Therefore, there is an urgent need to determine how spiritual and social domains of health at individual and family levels may advance lifestyle management interventions.

Full description

The overall objective for this study is to determine the effectiveness of a more holistic intervention targeting the individual and family levels to enhance health outcomes and program engagement among Native Americans in the Deep South compared to standard approaches. Our central hypothesis is that the integration of spiritual and social domains of health into the standard lifestyle intervention approach will significantly improve attendance, retention, and cardiometabolic profiles of Deep South Native Americans. This hypothesis is supported by our own preliminary data that health behaviors of Deep South Native Americans are fostered by family support and hindered by fatalistic attitudes. The rationale that underlies the proposed research is that demonstration of the feasibility and effectiveness of an intervention that integrates spiritual and social domains will provide new opportunities for its continued development as a strategy to improve disease management/prevention best practices in Deep South Native Americans.

The specific aims for the study are to develop a conceptual model to define spiritual factors and spiritually- and socially-enhanced intervention components that could advance lifestyle management interventions among Native Americans in the Deep South and to determine feasibility of lifestyle intervention components and study instruments among Native Americans in the Deep South. The plan is to to pilot recruitment methods, standard lifestyle intervention components, and implementation protocol and procedures to assess acceptability, optimize population engagement, and improve fidelity of delivery.

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • men or women who self-identify as Native American
  • current resident of the Mississippi study site
  • at least 18 years of age or older at the time of enrollment
  • BMI ≥ 24kg/m2.

Exclusion criteria

  • individuals with complicated or contraindicated disease diagnosis (i.e., kidney failure or insulin dependent type 2 diabetes) or who are pregnant or within six weeks postpartum

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

280 participants in 1 patient group

Move & Eat 2 Live
Other group
Description:
5, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.
Treatment:
Behavioral: Behavioral Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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