Addressing Diabetes by Elevating Access to Nutrition

Study Overview
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Brief Summary
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The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes. Specifically, ADELANTE aims to determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months, examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.

Detailed Description
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Participants and up to two of their household members will be randomized to one of two groups: healthy food box home delivery for 12 weeks plus a 12-month remotely delivered lifestyle behavioral intervention, Vida Sana, which incorporates family members and is aligned with Latino cultural values, or a wait list control group who will receive the food box deliveries 6 months later (but not the Vida Sana intervention). The first 6 months will evaluate the effects of receiving Vida Sana plus food delivery versus being randomized to control (no intervention); the final 6 months will evaluate receiving food delivery with versus without Vida Sana. VIDA SANA (intervention arm): The Vida Sana intervention is a cultural adaptation of Group Lifestyle Balance, a 12-month group program in turn adapted from the NIH/NIDDK-supported Diabetes Prevention Program (DPP). It has been shown to be effective in promoting clinically significant, modest weight loss and significant improvements in moderate-intensity physical activity. Participants receive a total of 23 group sessions over 12 months with a trained health coach who provides personalized feedback based on self-tracking. The program emphasizes a) moderate caloric reduction by 500-1,000 calories per day through healthy substitutions, b) incremental increases in moderate physical activity such as brisk walking, and c) behavioral strategies to support successful adoption and maintenance of healthy behaviors. These behavioral strategies include realistic goal setting, fostering social support, and stress management. Study health coaches will also add COVID-specific topics to ensure that participants are equipped to change behavior and manage stress during the pandemic. FOOD BOXES (intervention arm (immediately) and control arm (6 months later)): Each healthy food box delivery will include a variety of seasonal produce and a rotation of different whole grain foods (3+ grams of fiber/serving) such as cereal, pasta, tortillas, bread, and crackers. Participants will receive familiar foods as well as (intentionally) unfamiliar items to encourage them to try new foods. All items are also available at low-cost grocery stores so participants can continue to purchase them after the end of the study if they wish. The quantity is scaled to three household sizes. It is intended to supplement a family's food supply and provide opportunities for trying new fiber-rich foods recommended by the Vida Sana intervention.

Official Title
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Addressing Diabetes by Elevating Access to Nutrition: The ADELANTE Study

Conditions
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Diabetes, Obesity, Lifestyle, Healthy

Intervention / Treatment
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* Behavioral: Vida Sana (a Group Lifestyle Intervention)
* Behavioral: Supplemental Healthy Food Deliveries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For main study (index/intervention) participants: Age at enrollment: 18+ years Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value Have indicated food insecurity according to the screening 2-item Hunger Vital Sign questionnaire Have a Body Mass Index (BMI) => 25 Receiving care at our partnering community health centers (e.g., Clinica de la Raza) Currently residing in Alameda or Contra Costa County and not expecting to relocate in the next 6-12 months Have access to phone or computer, email, and some internet for access to remote intervention and completion of follow-up measures For household members: Age at enrollment: 12+ years Significantly involved in supporting nutrition in the home including food shopping, preparation, social support for healthy nutrition Willing to complete some questionnaires and attend a single group session. For all participants: Able and willing to provide informed consent Exclusion Criteria: Unable to provide informed consent Unable to speak, read, or understand English and/or Spanish Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments Lacking mailing address for delivery of food box Planning to relocate out of area within the next 12 months Index participant only: Pregnant or planning to become pregnant within the next 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to receive household food deliveries and intensive lifestyle intervention OR to a waitlist control group who only receives the household food deliveries (after a 6 month wait). Both groups will be followed for 12 months. Both groups will continue usual primary care for their diabetes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food and Lifestyle Intervention Group<br>The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach. | Behavioral: Vida Sana (a Group Lifestyle Intervention)<br>* Vida Sana is a Group Lifestyle intervention that has been shown to be effective among patients with type 2 diabetes (T2DM). Vida Sana includes 23 group sessions with a trained health coach: Months 1-4: 1 family-wide orientation + 12 weekly sessions Months 5-6: 4 bimonthly group sessions Months 7-12: 6 monthly group sessions All regular primary care and diabetes care will remain as usual.<br>Behavioral: Supplemental Healthy Food Deliveries<br>* Participants will receive 12 weeks of weekly food deliveries from Dig Deep Farms. Each delivery will include a selection of seasonal fresh vegetables and a rotation of either a whole grain or a whole-grain food (3+ grams of fiber/serving). Whole grains will include brown rice, oatmeal, barley, quinoa; whole grain foods will include cereal, pasta, tortillas, bread, crackers. Delivery sizes will be scaled to the three corresponding household sizes: 2-3 people; 4-5 people; or 6 or more people. Food will be delivered by Dig Deep Farms, which already has an established food subscription delivery system. (Control group participants will receive the same delivery schedule, but delayed to begin 6 months after their study enrollment.)<br>|
| Experimental: Waitlist Control Group<br>The waitlist control will continue usual care with no intervention for 6 months. To balance rigor with ethical considerations, they will receive the healthy food box deliveries after a 6 month waiting period. | Behavioral: Supplemental Healthy Food Deliveries<br>* Participants will receive 12 weeks of weekly food deliveries from Dig Deep Farms. Each delivery will include a selection of seasonal fresh vegetables and a rotation of either a whole grain or a whole-grain food (3+ grams of fiber/serving). Whole grains will include brown rice, oatmeal, barley, quinoa; whole grain foods will include cereal, pasta, tortillas, bread, crackers. Delivery sizes will be scaled to the three corresponding household sizes: 2-3 people; 4-5 people; or 6 or more people. Food will be delivered by Dig Deep Farms, which already has an established food subscription delivery system. (Control group participants will receive the same delivery schedule, but delayed to begin 6 months after their study enrollment.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgbA1c | Study staff will gather fingerstick blood samples for HgbA1c. | Baseline through 12 months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nonHDL Cholesterol | Study staff will gather fingerstick blood samples for lipid measurements, focusing on non- HDL cholesterol (total minus HDL cholesterol) which is a valuable marker of atherogenic dyslipidemia in diabetic individuals that does not require a fasting state. | Baseline through 12 months post-enrollment | 
| Blood Pressure | Blood pressure will be measured with an automated cuff with digital readout, or using a traditional sphygmomanometer. A study staff member will conduct the reading. Both systolic and diastolic pressure will be measured. | Baseline through 12 months post-enrollment | 
| Change in Body Mass Index (BMI) | Weight (kg) and height (cm) will be measured and Body Mass Index (BMI) will be calculated in kg/m^2. Height and weight will be gathered using standardized protocols with a portable scale and stadiometer. At baseline, these will be measured in triplicate for accuracy. | Baseline through 12 months post-enrollment | 
| Change in waist-height ratio | Waist-height ratio (cm) will be calculated and compared over time. Waist circumference (cm) will be measured at iliac crest. Height (cm) will be measured using standardized protocols. | Baseline through 12 months post-enrollment | 
| Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C) | Participants will answer 10 questions about their stress related to the pandemic. Scale is made up of 10 items, each of which offers five response options: never, almost never, occasionally, almost always and always. Items 1, 2, 3, 6, 9 and 10 are scored directly from 0 to 4 and items 4, 5, 7 and 8, conversely, from 4 to 0. Scores range from 0 to 40, higher scores indicating greater stress. The PSS-10-C was adapted from the Scale of Perceived Stress (PSS-10) and independently validated during March 2020 in response to government-mandated COVID-19 quarantines in Columbia (see Campo-Arias et al 2020 in the references section) | Baseline through 12 months post-enrollment | 
| Type 2 Diabetes Mellitus Related Stress | Diabetes-related stress will be measured using the validated 20-item Problem Areas in Diabetes Survey (PAID) questionnaire. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score. Scores range from 0 to 100, higher scores reflecting greater emotional distress. | Baseline through 12 months post-enrollment | 
| Health-related quality of life (adult participants only) | Index participants and adult household members will receive the Short Form-8 (SF-8) questionnaire. SF-8 is an 8-item instrument that measures general aspects of health-related quality of life. Each item covers a different domain: overall health, physical functioning, role physical (difficulties with daily work because of physical pain), bodily pain, vitality, social functioning, mental health, and role emotional (absence from daily activities because of emotional problems). Items are assessed individual 5- or 6-point Likert scales, a higher score on each question indicates poorer quality of life in that domain. | Baseline through 12 months post-enrollment | 
| Health-related quality of life (adolescent household members only) | Instead of the SF-8 (see previous outcome), adolescent household members will receive the Kid-Screen-10, a questionnaire is designed for children ages 8-18 to assess subjective health and psychological, mental, and social well-being. Scores range from 10 to 50, with higher scores indicating higher health-related quality of life. | Baseline through 12 months post-enrollment | 
| Depression | Possible depression will be measured using the Patient Health Questionnaire (PHQ-8), which measures 8 criteria from the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders). Each criteria is scored from 0 (not at all) to 3 (nearly every day). Range is 0-24, higher total score indicates more severe depression. | Baseline through 12 months post-enrollment | 
| Depression (index participant only) | For index participants, depression will be measured using the Patient Health Questionnaire (PHQ-9), which measures 8 criteria from the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and a ninth question on suicidal thoughts. Each criteria is scored from 0 (not at all) to 3 (nearly every day). Range is 0-27, higher total score indicates more severe depression. | Baseline through 12 months post-enrollment | 
| Anxiety | Level of anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). This is a 7 item instrument that uses some of the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) criteria for General Anxiety Disorder along with measuring anxiety symptom severity. Scores range from 0 to 21, higher scores indicate more severe anxiety. | Baseline through 12 months post-enrollment | 
| Self-reported Loneliness | The validated UCLA 3 item Loneliness Scale will be used. The scale is designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as hardly ever (1), some of the time (2), or often (3). Scores range from 3 to 9, higher scores indicate greater levels of loneliness. | Baseline through 12 months post-enrollment | 
| Dietary Intake Over 24 Hour Period (index participants only) | Index participants will complete three 24-hour diet recalls using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool. The module includes multiple-pass methodology to capture all foods eaten in the previous 24 hours. A researcher will administer the tool to reduce respondent burden. Output for 24-hour diet recall is extensive, but will include our key dietary outcomes for daily (averaged) intakes of: total vegetables, dark green vegetables, beans/legumes, and whole grains. Scores: Healthy Eating Index (HEI): 0 to 100, higher indicates greater alignment with healthy dietary guidelines Fruit & vegetable: 0-20 servings/day, higher scores preferred Total calorie intake: 1000-6000 kcal/day Total fat: 0-400 g/day Interview method adapted from Conway et al 2004 (see references section). | Baseline through 12 months post-enrollment | 
| Dietary Intake (household members only) | Household members will be given the 10-item Dietary Screener Questionnaire (DSQ-10). The questionnaire will capture consumption of fruit/vegetables, fiber, whole grains, and added sugars. Scores range from 0 to 100, higher scores indicate more frequent consumption of healthy foods. They will also be asked additional questions about whole grain foods, which will be scored the same way. These will be based on the dietary screener developed by Thompson and colleagues (see Thompson et al 2017 in references section). | Baseline through 12 months post-enrollment | 
| Diet-Related Behaviors: Food Preferences & Consumption | We will create a multi-part questionnaire to assess diet-related behaviors: Self-efficacy to eat fruits/vegetables will be measured using selected items from the National Cancer Institute's Food Attitudes and Behaviors Survey. Scores range from 7 to 35, higher score indicates greater self-efficacy/confidence in ability to consume fresh fruits and veg. To assess food preferences, participants will be asked Likert-style questions about specific vegetables and whole grains. Higher score indicates stronger liking. To assess healthy food consumption, participants will be asked a series of questions about whether they ate specific whole grain foods in the past 7 days. Higher score indicates more frequent consumption. There will also be three questions specifically about participants use of brown rice (regular and instant). Individual answers will be compared across time points. | Baseline through 12 months post-enrollment | 
| Changes in Diet-Related Behaviors | Participants will be asked a series of questions designed by the research team to examine changes in their whole grain and vegetable consumption over the past 6 months. Higher score is generally a better outcome as it indicates increase in consumption of these healthy foods. | 6 months through 12 months post-enrollment | 
| Change in physical activity | Using the 7-day Physical Activity Recall, each participant will complete a semi-structured interview that estimates their time spent doing physical and sleep activities in the past 7 days. Scores are: Leisure time moderate and vigorous physical activity, ranging from 0-1500 min/week, higher scores preferred Total energy expenditure, ranging from 06-60 kcal per kg per day, lower scores preferred. | Baseline through 12 months post-enrollment | 
| Food Neophobia Scale (FNS) | Comprises 10 items to which responses are given on a seven-point Likert scale ranging from strongly disagree to strongly agree. Score ranges from 10 to 70, a higher total score indicates greater food neophobia level and lower tendency to try unfamiliar foods. | Baseline through 12 months post-enrollment | 
| Control Over Food Choices | Participants will be asked a three part-questionnaire about control and food choices in the past 6 months: Nutrition security is measured with 4 items about food choice availability. Answers are never, rarely, sometimes, often, or always; higher rankings indicates greater nutrition insecurity. Scores range 0-16. Healthfulness Control is measured with 2 items about sense of control over what they ate or served to their families. Answers are never, rarely, sometimes, often, or always; higher rankings indicates greater control. Scores range 0-8. Utilization barriers are measured with 2 items about whether participants are able to select healthy foods and make healthy meals. Each item is ranked never true, sometimes true, often true; higher ranking indicates greater utilization barrier. Scores range 0-8. | Baseline through 12 months post-enrollment | 
| Nutrition Security Screener | The Nutrition Security Screener (NSS) was developed by Tufts University, Kaiser Permanente, and Los Angeles Department of Public Health. The questionnaire contains 14 questions, divided into two sections: How hard was it for you or your household to regularly get and eat healthy foods? Answers are very hard (0) , hard (1), somewhat hard(2) not very hard (3) and not hard at all. (4). Participants are asked rate 13 different barriers to being able to eat or prepare healthy meals. Each item is ranked very little or not at all, somewhat or a great deal. Question 1 will be scored on a scale of 1-4 to indicate if food security is very low, low, marginal, or secure. Measure designers have not validated a scale for question 2, so it will be analyzed descriptively. | Baseline through 12 months post-enrollment | 
| Interest in Community Supported Agriculture (CSA) Programs | Community Supported Agriculture (CSA) is a local farm-to-table model where customers can sign up for a subscription with a local farm and receive a weekly box of seasonal fruits and vegetables. Participants will be asked a 4 item questionnaire to gauge their experiences with, and interest in, such food boxes, including how much they would be willing to spend for one (e.g. $10-20 per bag). There is no scoring rubric, results are descriptive. | Baseline through 12 months post-enrollment | 
| Household Food Insecurity | Each participant will complete the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form to measure household food security. Raw scores are converted into food security status as follows: 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security. | Baseline through 12 months post-enrollment | 
| Food Assistance Programs | Participants are asked whether their household currently receives (or has received in the past 6 months) various sorts of food assistance, such as: Women, Infants and Children Program (WIC) government food assistance programs known as CalFresh, SNAP (Supplemental Nutrition Assistance Program), EBT (Electronic Benefits Transfer), or food stamps other sources of free food within the last 6 months such as church, food pantry / food bank, soup kitchen, etc, including an open-ended question There is no scoring rubric, results are descriptive. | Baseline through 12 months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food insecurity, community health worker, health coach, weight loss, HbA1c, T2DM, glycemic control, multilevel