Cooking for Health

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Cooking for Health in a Large American Indian Community in the North-Central United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699709
• Other study ID #: STUDY00004114
• Secondary ID: R01MD011596
• Status: Completed
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: November 26, 2023

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 26, 2023
• Est. primary completion date: November 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Budgeting, purchasing and cooking educational intervention
Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum

Locations

Country	Name	City	State
United States	Missouri Breaks Industries Research Inc	Eagle Butte	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Medstar Health Research Institute, Missouri Breaks Industries Research, Inc., National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	change (from baseline) in food budgeting skills (measured using the Food Resource Management Scale) at 6 months and 12 months	Change in food budgeting skills will be estimated using the Food Resource Management Scale. The scale includes 4 questions related to shopping behaviors to maximize food resources. The Food Resource Management Scale is a Likert-type scale with responses ranging from 1 (never) to 5 (always). Responses to the four questions will be averaged to create a total Food Resource Management Score. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase food budgeting skills, higher after-before differences represent a better outcome.	measured at baseline, and months 6 and 12
Secondary	change (from baseline) in cooking skills (measured using the Cooking Confidence Scale) at 6 months and 12 months	Change in cooking skills will be estimated using a minor modification of the Cooking Confidence Scale. The Cooking Confidence Scale includes 6 questions related to confidence in preparing healthy foods. It is a Likert-type scale with responses ranging from 1 (not at all confident) to 5 (very confident). Responses to the questions will be averaged. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase cooking skills, higher after - before differences represent a better outcome.	measured at baseline, and months 6 and 12
Secondary	Process evaluation: intervention reach	The proportion of those approached that participate in intervention (and the number who subsequently participate) will be used as a marker of intervention reach.	through study completion, estimated 12 months to complete intervention per participant
Secondary	Process evaluation: intervention fidelity	The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.	through study completion, estimated 12 months to complete intervention per participant
Secondary	Process evaluation: intervention satisfaction (among those in the intervention arm)	During months 6 and 12, a sub-sample of study participants in the intervention arm will meet with study staff by phone for semi-structured interviews to evaluate the overall intervention. Qualitative analyses will assess participant's satisfaction with the intervention.	Semi-structured interviews will be done at months 6 and 12.
Secondary	Process evaluation: intervention dose delivered (i.e., number of lessons included in the curriculum available for participants)	Dose will be assessed in the intervention arm only	through study completion, estimated 12 months to complete intervention per participant
Secondary	Process evaluation: intervention dose received (i.e., number of lessons included in the curriculum completed by participants)	Dose will be assessed in the intervention arm only	through study completion, estimated 12 months to complete intervention per participant