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The goal of this study was to develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.
Background and Rationale
Decades of increasing incidence of type 2 diabetes (T2D) present a multifaceted challenge to the health of a growing number of Americans, affecting their diets and how they live life. Approximately 30 million (~9%) of all people in the US have T2D, and this number is expected to continue to rise. At the same time, 15 million (11.8%) US households experience food insecurity, which is associated with risk for T2D and other chronic diseases. Both T2D and food insecurity are even more prevalent in Arkansas, with rates of T2D and food insecurity at 12.2% and 17.3%, respectively.
Approximately 46 million Americans per year turn to food pantries and related programs to help meet household nutritional needs. However, food pantries are not a long-term solution to improve health for food insecure people with T2D. Most food pantries do not provide food of sufficient dietary quality to support a healthy lifestyle.
Diabetes self-management education (DSME) is an approach with documented efficacy in helping people manage T2D. DSME supports informed decision-making, encourages goal setting and problem solving, and improves self-care behaviors. Recent studies have shown promise for DSME among food pantry clients with T2D. However, studies have suffered from problems with attendance and retention.
We designed a study to develop and evaluate the efficacy of a plain-language DSME curriculum to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D. We home-delivered this curriculum along with T2D-appropriate healthy food boxes to mitigate difficulties associated with access to healthy food and attendance at DSME sessions outside of the home. We hypothesized that this approach will lead to improvements in participants' glycemic control, diet quality, and other outcomes.
Study Population Up to 110 study participants will be recruited from food pantries located in Benton and Washington Counties in northwest Arkansas.
Inclusion Criteria:
Exclusion Criteria:
Study Design and Procedures For each participant, participation took place over 22 weeks (Weeks 1-4: Pre-intervention data collection; Weeks 5-16: Intervention; Weeks 17-22: Post-intervention data collection). Data collection took place at pre-intervention and post-intervention for each participant. At enrollment (i.e., pre-intervention) and one week after the 12th food box delivery (i.e. post-intervention), participants provided data on glycemic control (measured by HbA1c), physical activity, body mass index (BMI), T2D self-management behaviors, T2D knowledge, T2D self-efficacy, and food security. To enhance the study's significance in characterizing the diet patterns and fruit and vegetable consumption of low-income food insecure people with T2D, we collected extensive diet quality data measures pre-intervention and post-intervention.
Data Analysis To examine the intervention's effect on the primary outcomes of glycemic control as measured by HbA1c and diet quality as measured by Healthy Eating Index-2015 (HEI) scores, we used mixed effects regression models for repeated measures. These analyses focused on testing for a statistically significant difference between pre-intervention versus post-intervention measures. Analyses included relevant covariates such as sex or age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Appropriate Food Boxes + Diabetes Education | Experimental | All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type 2 Diabetes Appropriate Food Boxes + Diabetes Education | Behavioral | All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c), % | A Siemens analyzer was utilized to measure HbA1c (%) via finger stick blood collection. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Quality | Total skin carotenoid level was measured using a Veggie Meter optical skin scanner using Raman Spectroscopy. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables. | Baseline; immediate post-intervention (approx. 20 weeks) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Krista N Langston, MBA | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences Northwest | Fayetteville | Arkansas | 72703 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 2 Diabetes Appropriate Food Boxes + Diabetes Education | All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. Type 2 Diabetes Appropriate Food Boxes + Diabetes Education: All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 2 Diabetes Appropriate Food Boxes + Diabetes Education | All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. Type 2 Diabetes Appropriate Food Boxes + Diabetes Education: All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1c (HbA1c), % | A Siemens analyzer was utilized to measure HbA1c (%) via finger stick blood collection. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline; immediate post-intervention (approx. 20 weeks) |
|
From enrollment to approximately 20 weeks post-intervention
Study staff assessed adverse events via regular contact with participants throughout the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 2 Diabetes Appropriate Food Boxes + Diabetes Education | All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. Type 2 Diabetes Appropriate Food Boxes + Diabetes Education: All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Langston | University of Arkansas for Medical Sciences | 479-713-8000 | KNLangston@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2023 | Oct 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2023 | Dec 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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All participants will be assigned to a single intervention arm.
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|
| Diet Quality (2) | 24 hour dietary recalls was collected using the Nutrition Data System for Research (NDSR). NDSR was used to calculate Healthy Eating Index-2015 (HEI) scores. HEI is a metric used to assess the quality of a person's diet by comparing their food intake to the Dietary Guidelines for Americans, with a higher score indicating a diet that more closely aligns with recommended nutritional guidelines. HEI scores range from 0 to 100, where a higher score is better. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Body Mass Index (BMI) | Weight and height was used to compute a continuous measure of BMI (kilograms per square meter). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Chronic Diseases | Self-report items from the Behavioral Risk Factor Surveillance System (BRFSS) survey assessed lifetime prevalence of chronic diseases. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Self-Efficacy | Self-efficacy for self-management of type 2 diabetes was assessed using the eight item Diabetes Self-Efficacy Scale (DSES). The DSES assesses confidence in a person's perceived capability to perform necessary type 2 diabetes self-care activities including, maintaining healthy diet, engaging in exercise, and performing blood sugar monitoring (0, Not at all confident to 10, Totally confident). The score for the scale is the mean of the eight items, producing a range of scores of 0-10, with higher scores indicating higher levels of confidence to perform diabetes self-management activities. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Oral Health | Oral health was assessed by a single self-report item from the BRFSS, asking length of time since a dental cleaning ("Within the past year=1; Within the past 2 years=2; Within the past 5 years=3; 5 or more years ago=4; Never=5"). A lower score indicates a better outcome (more recent dental cleaning). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes-related Distress | Psychological distress related to type 2 diabetes was assessed using the Problem Areas in Diabetes 5-item scale (PAID-5) scale. The PAID-5 is used to assess the emotional distress related to living with type 2 diabetes, consisting of five questions that focus on feelings like fear, depression, worry about future complications, feeling overwhelmed by diabetes management, and coping with diabetes complications; essentially measuring the psychological impact of managing diabetes on a person's daily life (0, Not a problem to 4, Serious problem). The sum of the items produces a total score that ranges from 0-20, with lower scores indicating less distress. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Food Security | Food security was assessed using the Hunger Vital Sign two-question screening tool. Food security was not assessed at post-intervention, therefore no data can be reported for this measure. | Baseline |
| Food Pantry Utilization | Food pantry utilization was assessed through a single survey item adapted from Feeding America's Hunger in America survey. The item asked how many times the participant got food from a food pantry in the past 30 days. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Medication Adherence | Type 2 diabetes medication adherence was collected using responses to six items (0, No; 1, Yes) from the National Health Interview Survey (NHIS). The survey items assess how well individuals with diabetes adhered to their prescribed medication regimen, specifically by measuring whether they are taking medications correctly and refilling prescriptions as directed versus using non-adherence strategies to lower the cost of their medications (e.g., skipping doses, taking less medicine than prescribed, delaying filling prescriptions). Scores ranged from 0-6, with lower scores on the scale indicating a better outcome (e.g., better adherence to medication regimens). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Cooking Skills and Knowledge (1) | Cooking skills and knowledge were assessed using two items. The first item asks "How confident do you feel being able to cook from raw or basic ingredients?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure. | Baseline |
| Cooking Skills and Knowledge (2) | Cooking skills and knowledge were assessed using two items. The second item asks "How confident do you feel about following a simple recipe?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure. | Baseline |
| Type 2 Diabetes Self-Management Behaviors - General Diet | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The General Diet subscale is 2 items assessing how many days participants adhered to a diet plan (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Specific Diet | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Specific Diet subscale is 2 items assessing how many days participants ate certain types of foods (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Exercise | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Exercise subscale is 2 items assessing how many days participants engaged in exercise (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Blood Glucose Testing subscale is 2 items assessing how many days participants tested their blood sugar (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Foot Care | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Foot Care subscale is 2 items assessing how many days participants performed a foot check and inspected the inside of their shoes (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Smoking | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. Smoking was assessed using a single yes/no item. | Baseline; immediate post-intervention (approx. 20 weeks) |
| Type 2 Diabetes Self-Management Behaviors - Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Medication Adherence subscale is 2 items assessing how many days participants adhered to taking recommended diabetes medications (0-7 days per week). | Baseline; immediate post-intervention (approx. 20 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (%) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
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| Secondary | Diet Quality | Total skin carotenoid level was measured using a Veggie Meter optical skin scanner using Raman Spectroscopy. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline; immediate post-intervention (approx. 20 weeks) |
|
|
|
|
| Secondary | Diet Quality (2) | 24 hour dietary recalls was collected using the Nutrition Data System for Research (NDSR). NDSR was used to calculate Healthy Eating Index-2015 (HEI) scores. HEI is a metric used to assess the quality of a person's diet by comparing their food intake to the Dietary Guidelines for Americans, with a higher score indicating a diet that more closely aligns with recommended nutritional guidelines. HEI scores range from 0 to 100, where a higher score is better. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | HEI score | Baseline; immediate post-intervention (approx. 20 weeks) |
|
|
|
|
| Secondary | Body Mass Index (BMI) | Weight and height was used to compute a continuous measure of BMI (kilograms per square meter). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | kilograms per square meter | Baseline; immediate post-intervention (approx. 20 weeks) |
|
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|
|
| Secondary | Chronic Diseases | Self-report items from the Behavioral Risk Factor Surveillance System (BRFSS) survey assessed lifetime prevalence of chronic diseases. | There was a high degree of missingness on these items at baseline and post-intervention. | Posted | Count of Participants | Participants | Baseline; immediate post-intervention (approx. 20 weeks) |
|
|
|
| Secondary | Type 2 Diabetes Self-Management Self-Efficacy | Self-efficacy for self-management of type 2 diabetes was assessed using the eight item Diabetes Self-Efficacy Scale (DSES). The DSES assesses confidence in a person's perceived capability to perform necessary type 2 diabetes self-care activities including, maintaining healthy diet, engaging in exercise, and performing blood sugar monitoring (0, Not at all confident to 10, Totally confident). The score for the scale is the mean of the eight items, producing a range of scores of 0-10, with higher scores indicating higher levels of confidence to perform diabetes self-management activities. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline; immediate post-intervention (approx. 20 weeks) |
|
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|
|
| Secondary | Oral Health | Oral health was assessed by a single self-report item from the BRFSS, asking length of time since a dental cleaning ("Within the past year=1; Within the past 2 years=2; Within the past 5 years=3; 5 or more years ago=4; Never=5"). A lower score indicates a better outcome (more recent dental cleaning). | Analysis used all available data from participants. | Posted | Count of Participants | Participants | Baseline; immediate post-intervention (approx. 20 weeks) |
|
|
|
|
| Secondary | Type 2 Diabetes-related Distress | Psychological distress related to type 2 diabetes was assessed using the Problem Areas in Diabetes 5-item scale (PAID-5) scale. The PAID-5 is used to assess the emotional distress related to living with type 2 diabetes, consisting of five questions that focus on feelings like fear, depression, worry about future complications, feeling overwhelmed by diabetes management, and coping with diabetes complications; essentially measuring the psychological impact of managing diabetes on a person's daily life (0, Not a problem to 4, Serious problem). The sum of the items produces a total score that ranges from 0-20, with lower scores indicating less distress. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Food Security | Food security was assessed using the Hunger Vital Sign two-question screening tool. Food security was not assessed at post-intervention, therefore no data can be reported for this measure. | Results are for baseline only. Food security was not assessed at post-intervention due to survey programming errors, therefore no outcome data can be reported for this measure. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Food Pantry Utilization | Food pantry utilization was assessed through a single survey item adapted from Feeding America's Hunger in America survey. The item asked how many times the participant got food from a food pantry in the past 30 days. | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | times visited food pantry, past 30 days | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Medication Adherence | Type 2 diabetes medication adherence was collected using responses to six items (0, No; 1, Yes) from the National Health Interview Survey (NHIS). The survey items assess how well individuals with diabetes adhered to their prescribed medication regimen, specifically by measuring whether they are taking medications correctly and refilling prescriptions as directed versus using non-adherence strategies to lower the cost of their medications (e.g., skipping doses, taking less medicine than prescribed, delaying filling prescriptions). Scores ranged from 0-6, with lower scores on the scale indicating a better outcome (e.g., better adherence to medication regimens). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline; immediate post-intervention (approx. 20 weeks) |
|
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|
|
| Secondary | Cooking Skills and Knowledge (1) | Cooking skills and knowledge were assessed using two items. The first item asks "How confident do you feel being able to cook from raw or basic ingredients?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure. | Cooking skills and knowledge were not assessed at post-intervention due to survey programming errors, therefore no outcome data can be reported for this measure. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Cooking Skills and Knowledge (2) | Cooking skills and knowledge were assessed using two items. The second item asks "How confident do you feel about following a simple recipe?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure. | Cooking skills and knowledge were not assessed at post-intervention due to survey programming errors, therefore no outcome data can be reported for this measure. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - General Diet | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The General Diet subscale is 2 items assessing how many days participants adhered to a diet plan (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Specific Diet | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Specific Diet subscale is 2 items assessing how many days participants ate certain types of foods (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Exercise | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Exercise subscale is 2 items assessing how many days participants engaged in exercise (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Blood Glucose Testing subscale is 2 items assessing how many days participants tested their blood sugar (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Foot Care | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Foot Care subscale is 2 items assessing how many days participants performed a foot check and inspected the inside of their shoes (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Smoking | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. Smoking was assessed using a single yes/no item. | Analysis used all available data from participants. | Posted | Count of Participants | Participants | Baseline; immediate post-intervention (approx. 20 weeks) |
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| Secondary | Type 2 Diabetes Self-Management Behaviors - Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Medication Adherence subscale is 2 items assessing how many days participants adhered to taking recommended diabetes medications (0-7 days per week). | Analysis used all available data from participants. | Posted | Mean | Standard Deviation | days per week | Baseline; immediate post-intervention (approx. 20 weeks) |
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| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
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| D004700 | Endocrine System Diseases |
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| Post-intervention |
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| Within the past 5 years |
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| 5 or more years ago |
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| Never |
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| Post-intervention |
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| Post-intervention |
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| Not confident at all |
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| Post-intervention |
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| Not confident at all |
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| Post-intervention |
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| Post-intervention |
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