La Clínica Monument
Concord, California, 94518, United States
Location status: Recruiting
NCT Number: NCT05228860
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
1. 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, 2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and 3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Concord, California, 94518, United States
Location status: Recruiting
Participants and up to two of their household members will be randomized to one of two groups:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
All regular primary care and diabetes care will remain as usual.
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.)
Time frame: Baseline through 12 months post-enrollment
Study staff will gather fingerstick blood samples for HgbA1c.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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)
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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).
Time frame: Baseline through 12 months post-enrollment
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).
Time frame: Baseline through 12 months post-enrollment
We will create a multi-part questionnaire to assess diet-related behaviors:
Time frame: 6 months through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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:
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
Participants will be asked a three part-questionnaire about control and food choices in the past 6 months:
Time frame: Baseline through 12 months post-enrollment
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:
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
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.
Time frame: Baseline through 12 months post-enrollment
Participants are asked whether their household currently receives (or has received in the past 6 months) various sorts of food assistance, such as:
There is no scoring rubric, results are descriptive.
Contact information is provided by the study sponsor or research team.
Stanford University
Other
Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study
Acronym: ADELANTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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