Cooking for Health

NCT ID: NCT03699709

Last Updated: 2025-03-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2023-11-26

Brief Summary

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Type 2 diabetes is a leading cause of morbidity and mortality among American Indians (AIs) in the United States. Although healthy diet is a key component of diabetes management programs, many AIs face barriers to adopting a healthy diet including: difficulty budgeting for food on low-incomes, low literacy and numeracy when purchasing food, and limited cooking skills. The proposed project will evaluate a culturally-targeted healthy foods budgeting, purchasing, and cooking skills intervention aimed at improving the cardio-metabolic health of AIs with type 2 diabetes who live in rural areas.

Detailed Description

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The research activities proposed in this application address a pressing need in American Indian (AI) communities - the evaluation of a culturally-tailored healthy food budgeting, purchasing, and cooking intervention to see whether it can improve diet and health among AIs with type 2 diabetes.

This randomized clinical trial will compare the efficacy of a culturally-tailored healthy food budgeting, purchasing, and cooking program on: (1) diet quality (i.e., intake of sugar-sweetened beverages, processed foods) and (2) healthy food budgeting and cooking skills, among AIs with type 2 diabetes who reside in a large AI community in the north-central United States. Additionally, the investigators will conduct a mixed methods process evaluation to assess intervention reach, fidelity, and participant satisfaction. Curriculum will be tailored to an AI population with diabetes, and directly address major barriers to healthy eating that were identified by community members and tribal leaders in recent focus groups including: (1) difficulty budgeting for food on low-incomes; (2) low literacy and numeracy when purchasing food (e.g., inability to use in-store scales to convert foods priced "per pound" to dollar values); (3) limited cooking skills. The investigators expect that implementation of a culturally-tailored diet intervention will be effective in promoting positive diet change, and increase healthy food budgeting and cooking skills.

Poorly controlled diabetes affects the health/longevity of those afflicted, and has profound effects on healthcare costs. Greater efforts are needed to encourage healthy eating in underserved communities with a high burden of diabetes. Improving healthy food budgeting, purchasing, and cooking skills among AIs with diabetes should improve diet and diabetes management. If successful, this program can be extended to other AI communities.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to one of two arms: intervention or control group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Group Type EXPERIMENTAL

Budgeting, purchasing and cooking educational intervention

Intervention Type BEHAVIORAL

Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum

Control Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Budgeting, purchasing and cooking educational intervention

Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* American Indian
* 18+ years
* self-reported type 2 diabetes
* reside on reservation where study is being conducted
* self-identify as person who holds most of the responsibility for household budgeting, shopping, and cooking

Exclusion Criteria

* pregnant
* history of bariatric surgery
* chronic kidney disease
* on dialysis
* cognitively impaired
* individuals without a reliable place to cook or store food (e.g., homeless)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role collaborator

Missouri Breaks Industries Research, Inc.

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Amanda Fretts

Assistant Professor, School of Public Health: Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda M Fretts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Missouri Breaks Industries Research Inc

Eagle Butte, South Dakota, United States

Site Status

Countries

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United States

References

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Hawley CN, Huber CM, Best LG, Howard BV, Umans J, Beresford SAA, McKnight B, Hager A, O'Leary M, Thorndike AN, Ornelas IJ, Brown MC, Fretts AM. Cooking for Health: a healthy food budgeting, purchasing, and cooking skills randomized controlled trial to improve diet among American Indians with type 2 diabetes. BMC Public Health. 2021 Feb 15;21(1):356. doi: 10.1186/s12889-021-10308-8.

Reference Type DERIVED
PMID: 33588808 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MD011596

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004114

Identifier Type: -

Identifier Source: org_study_id

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