The Okla Achokma Project

NCT06633939 | Completed

• 2 other identifiers: 22-880-081R56HL164335-01A1
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Diet; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (8)

• High Density Lipoprotein Cholesterol

  at enrollment

• Health-related quality of life

  at enrollment

• Blood Pressure

  at enrollment

• Self-Efficacy

  at enrollment

• Spirituality

  at enrollment

Other Outcomes (3)

• Girth circumference

  at enrollment

• Weight

  at enrollment

• Height

  enrollment

Study Arms (1)

Move & Eat 2 Live

OTHER

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

Behavioral: Behavioral Treatment

Interventions

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.

Move & Eat 2 Live

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of Southern Mississippi

Hattiesburg, Mississippi, 39406, United States

Location

Related Publications (2)

• 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.

  PMID: 29755046 BACKGROUND

• 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.

  PMID: 35628038 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer L Lemacks, PhD

  The University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: May 30, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 31, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-09

Locations

US (1)