The Okla Achokma Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Community Intervention to Improve CVD Risk Factor Control in Young American Indians

NCT06230705

Cholesterol, Elevated Diabetes Mellitus

NOT_YET_RECRUITING NA

Family-Centered Diabetes Project

NCT00006159

Diabetes

COMPLETED NA

Indigenous Supported Agriculture "Go Healthy"

NCT05773833

Diet, Healthy Blood Pressure Overweight or Obesity +2 more

COMPLETED NA

Food Resource Equity and Sustainability for Health

NCT03251950

BMI Blood Pressure

COMPLETED NA

Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

NCT06077162

Type 2 Diabetes

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Diet Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Move & Eat 2 Live

5, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.

Group Type OTHER

Behavioral Treatment

Intervention Type BEHAVIORAL

The theoretical framework for the Move \& Eat 2 Live intervention is guided by the health belief model (HBM), socioecological model (SEM) and motivational interviewing (MI) approach. Tailoring to the target community will include a standard cultural adaptation that will replace curriculum content and examples with Native American relevant foods, physical activities, and representation in materials. For this study, the intervention will be piloted in the target population and will include the first 5 sessions of the original 12-session program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Treatment

The theoretical framework for the Move \& Eat 2 Live intervention is guided by the health belief model (HBM), socioecological model (SEM) and motivational interviewing (MI) approach. Tailoring to the target community will include a standard cultural adaptation that will replace curriculum content and examples with Native American relevant foods, physical activities, and representation in materials. For this study, the intervention will be piloted in the target population and will include the first 5 sessions of the original 12-session program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes