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Indigenous Supported Agriculture "Go Healthy" (ISA)

Primary Purpose

Diet, Healthy, Blood Pressure, Overweight or Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Go Healthy" program
Sponsored by
Oklahoma State University Center for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet, Healthy focused on measuring Blood Pressure, Obesity, CBPR, American Indian, BMI, Food Environment, Blood Lipids

Eligibility Criteria

3 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Adult Participant Inclusion Criteria: 18-75 years of age Identify as Native American (index adult participant only) Reside in Osage Nation Plan to stay in Osage Nation in the next year Overweight ot obesity, defined as BMI >= 25 kg/m2, measured by research staff (index adult participant only) Willing and able to follow study procedures Child Participant Inclusion Criteria: 3-17 years of age Reside in Osage Nation Plan to stay in Osage Nation in the next year Willing and able to follow study procedures Exclusion Criteria: Those that are pregnant or planning to become pregnant during the study period

Sites / Locations

  • The Osage NationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

"Go Healthy" Intervention Group

Wait-list Control Group

Arm Description

"Go Healthy" program

Monetary compensation equal in value to the "Go Healthy" program

Outcomes

Primary Outcome Measures

Diet using Healthy Eating Index scores
Change in vegetable and fruit intake using the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24) 2022. This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI score will constitute our primary outcome.
Blood pressure (adults only)
Change in systolic and diastolic blood pressure
HDL (adults only)
Change in HDL levels measured in mg/dL
LDL (adults only)
Change in LDL levels measured in mg/dL
Total cholesterol (adults only)
Change in total cholesterol levels measured in mg/dL
Glucose (adults only)
Change in glucose levels measured in mg/dL
Triglycerides (adults only)
Change in triglyceride levels measured in mg/dL

Secondary Outcome Measures

BMI status using CDC guidelines
Change in BMI will be calculated by dividing weight in kilograms by height in meters squared. Using CDC guidelines, adults will be categorized into the following groups based 1) underweight (BMI < 18.5); 2) healthy weight (BMI = 18.5-24.9); 3) overweight (BMI = 25.0-29.9); 4) obese (BMI = 30.0-39.9), and 5) morbidly obese (BMI ≥ 40.0). Child BMI will be calculated as a continuous variable using the CDC Child and Teen BMI Calculator.
HbA1c (adults only)
Change in HbA1c levels
Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module
Change in food insecurity using the Household Food Security Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members. To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative. Consistent with USDA guidelines, 0-2 affirmatives indicate food security, and 3 or more affirmatives indicate food insecurity.
Overall health status using the Short Form-36
Change in overall health status with answer options of excellent, very good, good, fair, or poor using the Short Form-36.
Skin Carotenoids
Change in skin carotenoid score using the Veggie Meter instrument (scale ranging from 0 to 800). Higher scores indicate better outcome.

Full Information

First Posted
February 24, 2023
Last Updated
March 6, 2023
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Washington State University, University of Oklahoma, Osage Nation
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1. Study Identification

Unique Protocol Identification Number
NCT05773833
Brief Title
Indigenous Supported Agriculture "Go Healthy"
Acronym
ISA
Official Title
Osage Community Supported Agriculture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Washington State University, University of Oklahoma, Osage Nation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.
Detailed Description
The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings. Specific Aims: Conduct a randomized controlled trial to test the newly developed ISA program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity; Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Blood Pressure, Overweight or Obesity, Food Insecurity, Health Status
Keywords
Blood Pressure, Obesity, CBPR, American Indian, BMI, Food Environment, Blood Lipids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Go Healthy" Intervention Group
Arm Type
Experimental
Arm Description
"Go Healthy" program
Arm Title
Wait-list Control Group
Arm Type
No Intervention
Arm Description
Monetary compensation equal in value to the "Go Healthy" program
Intervention Type
Behavioral
Intervention Name(s)
"Go Healthy" program
Intervention Description
Weekly food boxes of fresh fruits and vegetables for 16 weeks; healthy eating and traditional foods curriculum available inside the box; monthly in-person healthy eating and traditional Indigenous foods cooking workshop; Indigenous cooking demonstration video website links to accompany recipes; and a kitchen starter kit with kitchen cooking supplies
Primary Outcome Measure Information:
Title
Diet using Healthy Eating Index scores
Description
Change in vegetable and fruit intake using the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24) 2022. This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI score will constitute our primary outcome.
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Blood pressure (adults only)
Description
Change in systolic and diastolic blood pressure
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
HDL (adults only)
Description
Change in HDL levels measured in mg/dL
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
LDL (adults only)
Description
Change in LDL levels measured in mg/dL
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Total cholesterol (adults only)
Description
Change in total cholesterol levels measured in mg/dL
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Glucose (adults only)
Description
Change in glucose levels measured in mg/dL
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Triglycerides (adults only)
Description
Change in triglyceride levels measured in mg/dL
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Secondary Outcome Measure Information:
Title
BMI status using CDC guidelines
Description
Change in BMI will be calculated by dividing weight in kilograms by height in meters squared. Using CDC guidelines, adults will be categorized into the following groups based 1) underweight (BMI < 18.5); 2) healthy weight (BMI = 18.5-24.9); 3) overweight (BMI = 25.0-29.9); 4) obese (BMI = 30.0-39.9), and 5) morbidly obese (BMI ≥ 40.0). Child BMI will be calculated as a continuous variable using the CDC Child and Teen BMI Calculator.
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
HbA1c (adults only)
Description
Change in HbA1c levels
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module
Description
Change in food insecurity using the Household Food Security Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members. To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative. Consistent with USDA guidelines, 0-2 affirmatives indicate food security, and 3 or more affirmatives indicate food insecurity.
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Overall health status using the Short Form-36
Description
Change in overall health status with answer options of excellent, very good, good, fair, or poor using the Short Form-36.
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)
Title
Skin Carotenoids
Description
Change in skin carotenoid score using the Veggie Meter instrument (scale ranging from 0 to 800). Higher scores indicate better outcome.
Time Frame
Measured at baseline and immediately post-intervention (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adult Participant Inclusion Criteria: 18-75 years of age Identify as Native American (index adult participant only) Reside in Osage Nation Plan to stay in Osage Nation in the next year Overweight ot obesity, defined as BMI >= 25 kg/m2, measured by research staff (index adult participant only) Willing and able to follow study procedures Child Participant Inclusion Criteria: 3-17 years of age Reside in Osage Nation Plan to stay in Osage Nation in the next year Willing and able to follow study procedures Exclusion Criteria: Those that are pregnant or planning to become pregnant during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Plante Burks, MPH
Phone
918-561-1580
Email
splante@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tori Taniguchi, MPH
Phone
918-561-1575
Email
tori.taniguchi@okstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valarie Jernigan, DrPH
Organizational Affiliation
Oklahoma State University Center for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Osage Nation
City
Pawhuska
State/Province
Oklahoma
ZIP/Postal Code
74056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jann Hayman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Indigenous Supported Agriculture "Go Healthy"

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