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Cooking for Health

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Budgeting, purchasing and cooking educational intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring diet, cooking skills

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Missouri Breaks Industries Research Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Process evaluation: intervention fidelity
The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.
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.
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
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

Full Information

First Posted
October 2, 2018
Last Updated
November 2, 2022
Sponsor
University of Washington
Collaborators
Medstar Health Research Institute, Missouri Breaks Industries Research, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03699709
Brief Title
Cooking for Health
Official Title
Cooking for Health in a Large American Indian Community in the North-Central United States
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Medstar Health Research Institute, Missouri Breaks Industries Research, Inc., National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diet, cooking skills

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to one of two arms: intervention or control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Budgeting, purchasing and cooking educational intervention
Intervention Description
Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
measured at baseline, and months 6 and 12
Title
change (from baseline) in healthy and unhealthy food purchases (measured using the Healthy/Unhealthy Food Acquisition Survey) at 6 months and 12 months
Description
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.
Time Frame
measured at baseline, and months 6 and 12
Secondary Outcome Measure Information:
Title
change (from baseline) in food budgeting skills (measured using the Food Resource Management Scale) at 6 months and 12 months
Description
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.
Time Frame
measured at baseline, and months 6 and 12
Title
change (from baseline) in cooking skills (measured using the Cooking Confidence Scale) at 6 months and 12 months
Description
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.
Time Frame
measured at baseline, and months 6 and 12
Title
Process evaluation: intervention reach
Description
The proportion of those approached that participate in intervention (and the number who subsequently participate) will be used as a marker of intervention reach.
Time Frame
through study completion, estimated 12 months to complete intervention per participant
Title
Process evaluation: intervention fidelity
Description
The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.
Time Frame
through study completion, estimated 12 months to complete intervention per participant
Title
Process evaluation: intervention satisfaction (among those in the intervention arm)
Description
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.
Time Frame
Semi-structured interviews will be done at months 6 and 12.
Title
Process evaluation: intervention dose delivered (i.e., number of lessons included in the curriculum available for participants)
Description
Dose will be assessed in the intervention arm only
Time Frame
through study completion, estimated 12 months to complete intervention per participant
Title
Process evaluation: intervention dose received (i.e., number of lessons included in the curriculum completed by participants)
Description
Dose will be assessed in the intervention arm only
Time Frame
through study completion, estimated 12 months to complete intervention per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda M Fretts, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missouri Breaks Industries Research Inc
City
Eagle Butte
State/Province
South Dakota
ZIP/Postal Code
57625
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33588808
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.
Results Reference
derived

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Cooking for Health

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