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Cooking for Health

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ClinicalTrials.gov Identifier: NCT03699709
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Medstar Health Research Institute
Missouri Breaks Industries Research, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Amanda Fretts, University of Washington

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Budgeting, purchasing and cooking educational intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to one of two arms: intervention or control group
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cooking for Health in a Large American Indian Community in the North-Central United States
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
Experimental: Intervention Arm Behavioral: Budgeting, purchasing and cooking educational intervention
Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum

No Intervention: Control Arm



Primary Outcome Measures :
  1. 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 [ Time Frame: measured at baseline, and months 6 and 12 ]
    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.

  2. change (from baseline) in self-reported intake (grams/day) of processed foods (measured using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Processed foods will be defined as self-reported intake of processed/pre-prepared foods and snacks included on the food frequency questionnaire. Intake of processed foods 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 food on the food frequency questionnaire by the recalled portion size, and then summing for all processed foods. 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 processed foods, lower (i.e., more negative) after - before differences represent a better outcome.

  3. change (from baseline) in food budgeting skills (measured using the Food Resource Management Scale) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    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 assessed individually, as well as averaged (primary outcome) 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.

  4. change (from baseline) in cooking skills (measured using the Cooking Confidence Scale) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change in cooking skills will be estimated using 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 assessed individually, as well as averaged (primary outcome). 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.

  5. change (from baseline) in healthy and unhealthy food purchases (measured using the Healthy/Unhealthy Food Acquisition Survey) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change in healthy and unhealthy food purchases will be estimated using the Healthy/Unhealthy Food Acquisition Survey. The survey includes a list of 44 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 44 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.


Secondary Outcome Measures :
  1. change (from baseline) in self-reported intake (servings/day) of fruits and vegetables (measured using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Intake of fruits and vegetables will be estimated using measures of consumption frequency (i.e., never, a few times per year, once per month, 2-3 times per month, once per week, twice per week, 2-3 times per week, 5-6 times per week, once per day, two or more times per day) and portion size (small, medium, or large). 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 food on the food frequency questionnaire by the recalled portion size, and then summing foods. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase intake of fruits and vegetables, higher after - before differences represent a better outcome.

  2. change (from baseline) in self-reported intake (grams/day) of whole grains (measured using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Intake of whole grains will be estimated using measures of consumption frequency (i.e., never, a few times per year, once per month, 2-3 times per month, once per week, twice per week, 2-3 times per week, 5-6 times per week, once per day, two or more times per day) and portion size (small, medium, or large). 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 food on the food frequency questionnaire by nutrient content of the recalled portion size, and then summing for all foods. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase intake of whole grains, higher after - before differences represent a better outcome.

  3. change (from baseline) in self-reported intake (grams/day) of legumes (measured using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Intake of legumes will be estimated using measures of consumption frequency (i.e., never, a few times per year, once per month, 2-3 times per month, once per week, twice per week, 2-3 times per week, 5-6 times per week, once per day, two or more times per day) and portion size (small, medium, or large). 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 food on the food frequency questionnaire by the recalled portion size, and then summing foods. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase intake of legumes, higher after - before differences represent a better outcome.

  4. change (from baseline) in cooking skills (using alternate scale—Healthy Food Preparation Scale) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change in cooking skills will be estimated using the Healthy Food Preparation Scale. The Healthy Food Preparation Scale includes 8 questions related to healthy food practices, including reading food nutrition labels and eating a balanced diet. It is a Likert-type scale with responses ranging from 1 (never) to 5 (always) or 1 (not at all confident) to 5 (very confident). Responses to the questions will be assessed individually. 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.

  5. change (from baseline) in food beliefs and attitudes at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change in food beliefs and attitudes will be estimated using 9 questions adapted from the Cooking Matters Cooking Confidence/Healthy Food Barriers Scale and the Food Beliefs and Attitudes Questionnaire. The 9 questions utilize a Likert-type scale with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Responses to the questions will be assessed individually. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase healthy food beliefs and attitudes, higher after - before differences represent a better outcome.

  6. change (from baseline) in body mass index (kg/m2) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Body mass index is a measure of obesity. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower BMI, lower (i.e., more negative) after - before differences represent a better outcome.

  7. change (from baseline) in waist circumference (cm) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower waist circumference, lower (i.e., more negative) after - before differences represent a better outcome.

  8. change (from baseline) in diabetes control (measured with hemoglobin A1c (%)) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Hemoglobin A1c is a measure of blood glucose levels over the past 8-12 weeks. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower HbA1c, lower (i.e., more negative) after - before differences represent a better outcome.

  9. change (from baseline) in fasting glucose (mg/dl) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower fasting glucose levels, lower (i.e., more negative) after - before differences represent a better outcome.

  10. change (from baseline) in diabetes medication usage at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower the number and/or dose of prescribed diabetes medications, lower dose or number of medications (i.e., more negative) after - before differences represent a better outcome.

  11. change (from baseline) in high density lipoproteins(mg/dL) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase HDL cholesterol, higher after- before differences represent a better outcome.

  12. change (from baseline) in triglycerides (mg/dL) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower triglycerides, lower (ie more negative) after - before differences represent a better outcome.

  13. change (from baseline) in low density lipoprotein (mg/dL) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower low density lipoprotein levels, lower (i.e., more negative) after - before differences represent a better outcome.

  14. change (from baseline) in blood pressures (i.e., systolic blood pressure and diastolic blood pressure) at 6 months and 12 months [ Time Frame: measured at baseline, and months 6 and 12 ]
    Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to lower both systolic and diastolic blood pressure, lower (i.e., more negative) after - before differences represent a better outcome.

  15. Process evaluation: intervention reach [ Time Frame: through study completion, estimated 12 months to complete intervention per participant ]
    The proportion of those approached that participate in intervention (and the number who subsequently participate) will be used as a marker of intervention reach.

  16. Process evaluation: intervention fidelity [ Time Frame: through study completion, estimated 12 months to complete intervention per participant ]
    The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.

  17. Process evaluation: intervention satisfaction (among those in the intervention arm) [ Time Frame: Semi-structured interviews will be done at months 6 and 12. ]
    Participants in the intervention arm will complete satisfaction questionnaires after the completion of each monthly lesson. Additionally, during the in-person visits at months 6 and 12, a sub-sample of study participants in the intervention arm will meet with study staff for semi-structured interviews to evaluate the overall intervention. Qualitative analyses will assess participant's satisfaction with the intervention.

  18. Process evaluation: intervention dose delivered (i.e., number of lessons included in the curriculum available for participants) [ Time Frame: through study completion, estimated 12 months to complete intervention per participant ]
    Dose will be assessed in the intervention arm only

  19. Process evaluation: intervention dose received (i.e., number of lessons included in the curriculum completed by participants) [ Time Frame: through study completion, estimated 12 months to complete intervention per participant ]
    Dose will be assessed in the intervention arm only



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years
  • self-reported type 2 diabetes
  • reside on reservation where study is being conducted
  • self-identify as person who holds the most responsibility for household budgeting, shopping, and cooking

Exclusion Criteria:

  • pregnant
  • history of bariatric surgery
  • chronic kidney disease
  • on dialysis
  • cognitively impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699709


Contacts
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Contact: Amanda M Fretts, PhD 206-543-9236 amfretts@uw.edu

Locations
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United States, South Dakota
Missouri Breaks Industries Research Inc Not yet recruiting
Eagle Butte, South Dakota, United States, 57625
Sponsors and Collaborators
University of Washington
Medstar Health Research Institute
Missouri Breaks Industries Research, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)

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Responsible Party: Amanda Fretts, Assistant Professor, School of Public Health: Epidemiology, University of Washington
ClinicalTrials.gov Identifier: NCT03699709     History of Changes
Other Study ID Numbers: STUDY00004114
R01MD011596 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Amanda Fretts, University of Washington:
diet
cooking skills

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases