The Okla Achokma Project
- Conditions
- HealthyDietPhysical Activity
- Interventions
- Behavioral: Behavioral Treatment
- Registration Number
- NCT06633939
- Lead Sponsor
- University of Southern Mississippi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Move & Eat 2 Live Behavioral Treatment 5, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.
- Primary Outcome Measures
Name Time Method Program engagement From first intervention session to the final (5th) intervention session at 10 weeks Program engagement will be measured by session attendance and program retention. Session attendance will be captured by the percentage of participants that attend each session. Retention will be examined based on three intervals. Interest retention will include the number of participants who completed the interest form versus those who expressed interest but did not complete the interest form, enrollment retention will include the number of participants who enrolled versus expressed interest but did not enroll, baseline retention will include number of participants who completed baseline data collection versus those who enrolled but did not complete baseline data collection.
Implementation fidelity from first intervention session to the final (5th) intervention session at 10 weeks To examine implementation fidelity, the initial four sessions will be randomly selected for in vivo observation by the primary investigator, co-investigators, and/or research staff. The assessment will be guided by a checklist that includes session information (time, place, session length, etc.), session components, and allows for account of session deviations, etc.
- Secondary Outcome Measures
Name Time Method High Density Lipoprotein Cholesterol at enrollment Lipid panel will be measured including cholesterol and High Density Lipoprotein Cholesterol using a portable analyzer and will require a small blood sample from a simple fingerstick.
Health-related quality of life at enrollment A 12-Item Short-Form Health Survey will be used to investigate individual's views about their health. This information will help keep track of how someone feels and how well they are able to do their usual activities.
Ware, J. E., Kosinski, M., \& Keller, S. D. (1996). A 12-Item Short-Form Health Survey: Construction of Scales and Preliminary Tests of Reliability and Validity. Medical Care, 34(3), 220-233. http://www.jstor.org/stable/3766749Blood Pressure at enrollment systolic and diastolic blood pressure measured in millimeters of mercury (mmHg)
Self-Efficacy at enrollment Validated self-efficacy questionnaire to measure diet and exercise behaviors. Sallis, J.F., Pinski, R.B., Grossman, R.M., Patterson,T.L., and Nader, P.R. (1988). The development of self-efficacy scales for health-related diet and exercise behaviors. Health Education Research, 3, 283-292.
Spirituality at enrollment Holistic assessment instrument focusing on beliefs, intuitions, lifestyle choices, practices, and rituals that represent the human spiritual dimension.
https://journals.sagepub.com/doi/pdf/10.1177/0898010105276180Disease Prevention Fatalism at enrollment Validated questionnaire to measure beliefs related to death and disease. Disease Prevention Fatalism: https://pubmed.ncbi.nlm.nih.gov/19908102/
Dietary Intake at enrollment DSQ Dietary Screener Questionnaires (DSQ) in the NHANES 2009-10: DSQ https://epi.grants.cancer.gov/nhanes/dietscreen/questionnaires.html#paper
Physcial Activity at enrollment Validated International Physical Activity Questionnaire, short form. IPAQ_English_telephone_short.pdf. (n.d.). https://www.google.com/url?sa=t\&source=web\&rct=j\&opi=89978449\&url=https://osf.io/6yfjf/\&ved=2ahUKEwiKn5S0l_OIAxXyG9AFHVV0OlsQFnoECBoQAQ\&usg=AOvVaw1JvoOLn0pQMye2UUBQt_DX
Trial Locations
- Locations (1)
The University of Southern Mississippi
🇺🇸Hattiesburg, Mississippi, United States