Diabetes Mellitus, Type 2NCT03699709
Cooking for Health
A study testing Budgeting, purchasing and cooking educational intervention in people with Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Budgeting, purchasing and cooking educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 26 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Breaks Industries Research Inc
Eagle Butte, South Dakota, 57625
About this study
Official title: Cooking for Health in a Large American Indian Community in the North-Central United States
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Budgeting, purchasing and cooking educational intervention
- Keywords
- diet, cooking skills
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budgeting, purchasing and cooking educational interventionBehavioural
Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Behavioral: Budgeting, purchasing and cooking educational intervention |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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
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: 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
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: measured at baseline, and months 6 and 12
Process Evaluation: Intervention Reach
The proportion of those approached that were eligible for the intervention (and the number who subsequently participate) will be used as a marker of intervention reach.
Measured: Years 2020-2023
Process Evaluation: Intervention Fidelity
The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.
Measured: through study completion, estimated 12 months to complete intervention per participant
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.
Measured: Semi-structured interviews will be done at months 6 and 12.
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
Measured: through study completion, estimated 12 months to complete intervention per participant
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
Measured: through study completion, estimated 12 months to complete intervention per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start27 Feb 2020
- Primary completion26 Nov 2023
- Study completion26 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to one of two arms: intervention or control group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute, Missouri Breaks Industries Research, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Amanda Fretts, University of Washington
- Investigators
- Amanda M Fretts, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699709
- Sponsor's protocol ID
- STUDY00004114
- Other IDs
- R01MD011596
- Status last verified
- Feb 2025
- First submitted
- 2 Oct 2018
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green SA, O'Leary R, Huber CM, Thorndike AN, Best LG, Brown MC, O'Leary M, Umans J, Hager A, Whitebull R, Beresford S, Fretts AM. Recruitment strategies for a randomized controlled trial in a rural American Indian community: the Cooking for Health Study. Trials. 2026 Jun 27. doi: 10.1186/s13063-026-09874-2. Online ahead of print.
PubMed 42365364Hawley 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.
PubMed 33588808
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooking for Health in a Large American Indian Community in the North-Central United States
- ClinicalTrials.gov ID
- NCT03699709
- Acronym / sponsor ID
- STUDY00004114
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diet, cooking skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute, Missouri Breaks Industries Research, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 26 Nov 2023 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to one of two arms: intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Budgeting, purchasing and cooking educational intervention |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- pregnant
- history of bariatric surgery
- chronic kidney disease
- on dialysis
- cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budgeting, purchasing and cooking educational interventionReceive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum | Behavioural | Intervention Arm |
Primary outcome
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.
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 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.
7 secondary outcomes
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 (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
Process Evaluation: Intervention Reach
Time frame: Years 2020-2023
Process Evaluation: Intervention Fidelity
Time frame: through study completion, estimated 12 months to complete intervention per participant
Process Evaluation: Intervention Satisfaction (Among Those in the Intervention Arm)
Time frame: Semi-structured interviews will be done at months 6 and 12.
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42365364Green SA, O'Leary R, Huber CM, Thorndike AN, Best LG, Brown MC, O'Leary M, Umans J, Hager A, Whitebull R, Beresford S, Fretts AM. Recruitment strategies for a randomized controlled trial in a rural American Indian community: the Cooking for Health Study. Trials. 2026 Jun 27. doi: 10.1186/s13063-026-09874-2. Online ahead of print.
- Derived from this study: PubMed 33588808Hawley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda M Fretts, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budgeting, purchasing and cooking educational intervention in people with Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: measured at baseline, and months 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699709, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.