Clinical trial NCT06633939: The Okla Achokma Project
Official title: The Okla Achokma Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Diet
Physical Activity
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Program engagement
timeFrame: From first intervention session to the final (5th) intervention session at 10 weeks
measure: Implementation fidelity
timeFrame: from first intervention session to the final (5th) intervention session at 10 weeks
Secondary outcomes:
measure: High Density Lipoprotein Cholesterol
timeFrame: at enrollment
measure: Health-related quality of life
timeFrame: at enrollment
measure: Blood Pressure
timeFrame: at enrollment
measure: Self-Efficacy
timeFrame: at enrollment
measure: Spirituality
timeFrame: at enrollment
measure: Disease Prevention Fatalism
timeFrame: at enrollment
measure: Dietary Intake
timeFrame: at enrollment
measure: Physcial Activity
timeFrame: at enrollment
Other outcomes:
measure: Girth circumference
timeFrame: at enrollment
measure: Weight
timeFrame: at enrollment
measure: Height
timeFrame: enrollment
Locations:
city: Hattiesburg
country: United States
facility: The University of Southern Mississippi
state: Mississippi
Study officials:
affiliation: The University of Southern Mississippi
name: Jennifer L Lemacks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemacks JL, James RE, Abbott L, Choi H, Parker A, Bryant A, Ralston PA, Rigsby AG, Gilner P. The Church Bridge Project: An Academic-Community Perspective of a Church-Based Weight Management Pilot Intervention among Young Adult African Americans. Prog Community Health Partnersh. 2018;12(1S):23-34. doi: 10.1353/cpr.2018.0018.
citation: Abbott L, Lemacks J, Greer T. Development and Evaluation of a Measure for Social Support Provided by Friends during Lifestyle Management Programs. Healthcare (Basel). 2022 May 13;10(5):901. doi: 10.3390/healthcare10050901.