Clinical trial NCT03699709: Cooking for Health
Official title: Cooking for Health in a Large American Indian Community in the North-Central United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diet
cooking skills
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
name: Missouri Breaks Industries Research, Inc.
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-10-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to one of two arms: intervention or control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change (From Baseline) in Self-reported Intake (Servings/Day) of Sugar-sweetened Beverages (Measured Using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 Months and 12 Months
timeFrame: measured at baseline, and months 6 and 12
measure: Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months
timeFrame: measured at baseline, and months 6 and 12
Secondary outcomes:
measure: Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months
timeFrame: measured at baseline, and months 6 and 12
measure: Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months
timeFrame: measured at baseline, and months 6 and 12
measure: Process Evaluation: Intervention Reach
timeFrame: Years 2020-2023
measure: Process Evaluation: Intervention Fidelity
timeFrame: through study completion, estimated 12 months to complete intervention per participant
measure: Process Evaluation: Intervention Satisfaction (Among Those in the Intervention Arm)
timeFrame: Semi-structured interviews will be done at months 6 and 12.
measure: Process Evaluation: Intervention Dose Delivered (i.e., Number of Lessons Included in the Curriculum Available for Participants)
timeFrame: through study completion, estimated 12 months to complete intervention per participant
measure: Process Evaluation: Intervention Dose Received (i.e., Number of Lessons Included in the Curriculum Completed by Participants)
timeFrame: through study completion, estimated 12 months to complete intervention per participant
Other outcomes:
Locations:
city: Eagle Butte
country: United States
facility: Missouri Breaks Industries Research Inc
state: South Dakota
Study officials:
affiliation: University of Washington
name: Amanda M Fretts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.