Cooking for Health

NCT03699709 | Completed Results

• 2 other identifiers: STUDY00004114R01MD011596
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diet; cooking skills

Outcome Measures

Primary Outcomes (2)

• 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

  Sugar-sweetened beverages include self-reported intake of fruit drinks, sugar-based energy drinks, and soda. Intake of sugar-sweetened beverages will be estimated using measures of consumption frequency and portion size. Average intakes will be calculated for each study participant using the University of Minnesota Nutrition Data Systems for Research Software by multiplying the frequency response for each beverage on the food frequency questionnaire by the recalled portion size, and then summing for all relevant beverages. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to decrease intake of sugar-sweetened beverages, lower (i.e., more negative) after - before differences represent a better outcome.

  measured at baseline, and months 6 and 12

• Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months

  Change in healthy and unhealthy food purchases will be estimated using the Healthy/Unhealthy Food Acquisition Survey. The survey includes a list of 47 healthy and unhealthy foods commonly consumed in the community. At each exam (baseline, month 6, month 12), participants will report the number of times he/she acquired each of the 47 foods in the past 30 days. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase the number of healthy food purchases and decrease the number of unhealthy food purchases, higher after - before differences represent a better outcome for healthy foods and lower after - before differences represent a better outcome for unhealthy foods.

  measured at baseline, and months 6 and 12

Secondary Outcomes (7)

• Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months

  measured at baseline, and months 6 and 12

• Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months

  measured at baseline, and months 6 and 12

• Process Evaluation: Intervention Reach

  Years 2020-2023

• Process Evaluation: Intervention Fidelity

  through study completion, estimated 12 months to complete intervention per participant

• Process Evaluation: Intervention Satisfaction (Among Those in the Intervention Arm)

  Semi-structured interviews will be done at months 6 and 12.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Behavioral: Budgeting, purchasing and cooking educational intervention

Control Arm

NO INTERVENTION

Interventions

Budgeting, purchasing and cooking educational intervention BEHAVIORAL

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Indian
• + 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Medstar Health Research Institute: collaborator
• Missouri Breaks Industries Research, Inc.: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Missouri Breaks Industries Research Inc

Eagle Butte, South Dakota, 57625, United States

Location

Related Publications (1)

• 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.

  PMID: 33588808 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Budgets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Financial Management; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Amanda Fretts
• Organization: University of Washington School of Public Health Department of Epidemiology

amfretts@uw.edu

2065431065

Study Officials

• Amanda M Fretts, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health: Epidemiology

Model Details: Randomization to one of two arms: intervention or control group

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: February 27, 2020
• Primary Completion: November 26, 2023
• Study Completion: November 26, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)