Diabetes Mellitus, Type 2
Conditions
Keywords
diet, cooking skills
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.
Interventions
BEHAVIORALBudgeting, purchasing and cooking educational intervention
Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum
Sponsors
Medstar Health Research Institute
Missouri Breaks Industries Research, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomization to one of two arms: intervention or control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Process Evaluation: Intervention Reach | Years 2020-2023 | 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. |
| Process Evaluation: Intervention Fidelity | 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. |
| 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 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. |
| Process Evaluation: Intervention Dose Delivered (i.e., Number of Lessons Included in the Curriculum Available for Participants) | through study completion, estimated 12 months to complete intervention per participant | 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) | through study completion, estimated 12 months to complete intervention per participant | Dose will be assessed in the intervention arm only |
| Process Evaluation: Intervention Satisfaction (Among Those in the Intervention Arm) | Semi-structured interviews will be done at months 6 and 12. | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
No significant events after participant enrollment, but prior to randomization to intervention or control arm.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum | 88 |
| Control Arm No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study) | 88 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | incarcerated | 1 | 0 |
| Overall Study | Lost to Follow-up | 10 | 3 |
| Overall Study | scheduled, but no show | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 11.9 | 48.3 years STANDARD_DEVIATION 11.2 | 49.7 years STANDARD_DEVIATION 11.6 |
| Healthy Food Purchases | 62.4 purchases per 30 days STANDARD_DEVIATION 56 | 88.0 purchases per 30 days STANDARD_DEVIATION 75.2 | 75.3 purchases per 30 days STANDARD_DEVIATION 67.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 88 Participants | 88 Participants | 176 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 69 Participants | 58 Participants | 127 Participants |
| Sex: Female, Male Male | 19 Participants | 30 Participants | 49 Participants |
| Sugar-sweetened beverages | 1.2 servings per day STANDARD_DEVIATION 2.4 | 1.1 servings per day STANDARD_DEVIATION 1.6 | 1.2 servings per day STANDARD_DEVIATION 2 |
| Unhealthy Food Purchases | 39.4 purchases per 30 days STANDARD_DEVIATION 34.7 | 51.2 purchases per 30 days STANDARD_DEVIATION 38.2 | 45.3 purchases per 30 days STANDARD_DEVIATION 36.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 88 | 2 / 88 |
| other Total, other adverse events | 0 / 88 | 0 / 88 |
| serious Total, serious adverse events | 0 / 88 | 0 / 88 |
Outcome results
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.
Time frame: measured at baseline, and months 6 and 12
Population: Participants who completed the healthy and unhealthy food purchases questionnaire at the baseline and month 6 exam or the baseline and month 12 exam
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 12 months-baseline, unhealthy food purchases | -7.4 purchases per 30 days | Standard Error 3.3 |
| Intervention Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 6 months-baseline, unhealthy food purchases | -6.42 purchases per 30 days | Standard Error 4.92 |
| Intervention Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 12 months-baseline, healthy food purchases | 7.24 purchases per 30 days | Standard Error 4.95 |
| Intervention Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 6 months-baseline, healthy food purchases | 0.84 purchases per 30 days | Standard Error 6.3 |
| Control Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 6 months-baseline, healthy food purchases | -10.5 purchases per 30 days | Standard Error 0.84 |
| Control Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 12 months-baseline, unhealthy food purchases | -10.1 purchases per 30 days | Standard Error 3.7 |
| Control Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 12 months-baseline, healthy food purchases | -16.3 purchases per 30 days | Standard Error 8.56 |
| Control Arm | Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months | 6 months-baseline, unhealthy food purchases | -9.91 purchases per 30 days | Standard Error 4.25 |
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.
Time frame: measured at baseline, and months 6 and 12
Population: Participants who completed the food frequency questionnaire at the baseline and month 6 exam or the baseline and month 12 exam
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | 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 | 12 months-baseline | -0.13 servings | Standard Error 0.38 |
| Intervention Arm | 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 | 6 months-baseline | -0.22 servings | Standard Error 0.23 |
| Control Arm | 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 | 12 months-baseline | -0.11 servings | Standard Error 0.28 |
| Control Arm | 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 | 6 months-baseline | -0.28 servings | Standard Error 0.21 |
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.
Time frame: measured at baseline, and months 6 and 12
Population: Participants who completed the Cooking Confidence Scale questions at the baseline and month 6 exam or the baseline and month 12 exam
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months | 12 months-baseline | 0.16 score on a scale | Standard Error 0.08 |
| Intervention Arm | Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months | 6 months-baseline | 0.21 score on a scale | Standard Error 0.06 |
| Control Arm | Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months | 12 months-baseline | -0.18 score on a scale | Standard Error 0.09 |
| Control Arm | Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months | 6 months-baseline | -0.06 score on a scale | Standard Error 0.08 |
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.
Time frame: measured at baseline, and months 6 and 12
Population: Participants who completed the Food Resource Management questions at the baseline and month 6 exam or the baseline and month 12 exam
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months | 12 months-baseline | 0.28 score on a scale | Standard Error 0.11 |
| Intervention Arm | Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months | 6 months-baseline | 0.08 score on a scale | Standard Error 0.12 |
| Control Arm | Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months | 12 months-baseline | -0.08 score on a scale | Standard Error 0.1 |
| Control Arm | Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months | 6 months-baseline | 0.05 score on a scale | Standard Error 0.1 |
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
Time frame: 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
Time frame: 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.
Time frame: through study completion, estimated 12 months to complete intervention per participant
Secondary
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.
Time frame: Years 2020-2023
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.
Time frame: Semi-structured interviews will be done at months 6 and 12.