Skip to main content
OpenTrials
Completed

NCT Number: NCT06633939

The Okla Achokma Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Diet Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Southern Mississippi

Hattiesburg, Mississippi, 39406, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment

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.

Primary outcomes

  1. Program engagement

    Time frame: 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.

  2. Implementation fidelity

    Time frame: 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 outcomes

  1. High Density Lipoprotein Cholesterol

    Time frame: 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.

  2. Health-related quality of life

    Time frame: 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/3766749

  3. Blood Pressure

    Time frame: at enrollment

    systolic and diastolic blood pressure measured in millimeters of mercury (mmHg)

  4. Self-Efficacy

    Time frame: 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.

  5. Spirituality

    Time frame: 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/10.1177/0898010105276180

  6. Disease Prevention Fatalism

    Time frame: at enrollment

    Validated questionnaire to measure beliefs related to death and disease. Disease Prevention Fatalism: https://pubmed.ncbi.nlm.nih.gov/19908102/

  7. Dietary Intake

    Time frame: at enrollment

    DSQ Dietary Screener Questionnaires (DSQ) in the NHANES 2009-10: DSQ https://epi.grants.cancer.gov/nhanes/dietscreen/questionnaires.html#paper

  8. Physcial Activity

    Time frame: 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

Other outcomes

  1. Girth circumference

    Time frame: at enrollment

    Waist, abdomen, and hip circumferences will be measured with a plastic, non-flexible, circumference measuring tape as the participant exhales.

  2. Weight

    Time frame: at enrollment

    Measured in lightweight clothing without shoes to the nearest 0.1kg/%.

  3. Height

    Time frame: enrollment

    Height will be measured without shoes using a stadiometer in ft and inches.

Sponsors and collaborators

Lead sponsor

University of Southern Mississippi

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: Okla Achokma

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.