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HealthyOkla AchokmaNCT06633939

The Okla Achokma Project

A study testing Behavioral Treatment in people with Healthy and Diet, run by University of Southern Mississippi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Diet, Physical Activity
What is being tested?
Behavioral Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
30 May 2024to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • The University of Southern Mississippi

    Hattiesburg, Mississippi, 39406

Other trials in United States

About this study

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.

Read the 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.

Being tested
Behavioral Treatment
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral TreatmentBehavioural

    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.

Study groups in NCT06633939
Study groupRoleWhat they receive
Move & Eat 2 LiveOther5, 1-hour sessions with an education and motivational component and focused on nutrition, physical activity and healthy weight.
Receives: Behavioral: Behavioral Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Program engagement

    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.

    Measured: From first intervention session to the final (5th) intervention session at 10 weeks

  2. Implementation fidelity

    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.

    Measured: from first intervention session to the final (5th) intervention session at 10 weeks

Secondary outcomes (8)

  1. High Density Lipoprotein Cholesterol

    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.

    Measured: at enrollment

  2. Health-related quality of life

    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

    Measured: at enrollment

  3. Blood Pressure

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

    Measured: at enrollment

  4. Self-Efficacy

    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.

    Measured: at enrollment

  5. Spirituality

    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

    Measured: at enrollment

  6. Disease Prevention Fatalism

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

    Measured: at enrollment

  7. Dietary Intake

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

    Measured: at enrollment

  8. Physcial Activity

    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

    Measured: at enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start30 May 2024
  3. Primary completion6 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633939
Sponsor's protocol ID
22-880-08
Other IDs
1R56HL164335-01A1
Acronym
Okla Achokma
Status last verified
Sep 2024
First submitted
26 Sep 2024
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29755046

  • 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.

    PubMed 35628038

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Treatment in people with Healthy and Diet, run by University of Southern Mississippi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program engagement (time frame: From first intervention session to the final (5th) intervention session at 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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