Addressing Diabetes by Elevating Access to Nutrition

Obesity Clinical Trial

— ADELANTE  

Official title:

Addressing Diabetes by Elevating Access to Nutrition: The ADELANTE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228860
• Other study ID #: 62283
• Secondary ID: 1R01MD016738-01
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: September 2027

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: Study Coordinator
• Phone: 650-725-5180
• Email: morizaga[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Participants and up to two of their household members will be randomized to one of two groups:

1. 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

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Lifestyle, Healthy
• Obesity

Intervention

Behavioral:
• Vida Sana (a Group Lifestyle Intervention)
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.
• Supplemental Healthy Food Deliveries
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.)

Locations

Country	Name	City	State
United States	La Clínica Monument	Concord	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Dig Deep Farms, La Clínica de La Raza Inc., National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (13)

Blair SN, Haskell WL, Ho P, Paffenbarger RS Jr, Vranizan KM, Farquhar JW, Wood PD. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985 Nov;122(5):794-804. doi: 10.1093/oxfordjournals.aje.a114163. — View Citation

Calloway EE, Carpenter LR, Gargano T, Sharp JL, Yaroch AL. Development of new measures to assess household nutrition security, and choice in dietary characteristics. Appetite. 2022 Dec 1;179:106288. doi: 10.1016/j.appet.2022.106288. Epub 2022 Aug 29. — View Citation

Campo-Arias A, Pedrozo-Cortes MJ, Pedrozo-Pupo JC. Pandemic-Related Perceived Stress Scale of COVID-19: An exploration of online psychometric performance. Rev Colomb Psiquiatr (Engl Ed). 2020 Oct-Dec;49(4):229-230. doi: 10.1016/j.rcp.2020.05.005. Epub 2020 Jul 17. No abstract available. English, Spanish. — View Citation

Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007. — View Citation

Domel SB, Baranowski T, Davis H, Leonard SB, Riley P, Baranowski J. Measuring fruit and vegetable preferences among 4th- and 5th-grade students. Prev Med. 1993 Nov;22(6):866-79. doi: 10.1006/pmed.1993.1078. — View Citation

Ellison B, McFadden B, Rickard BJ, Wilson N. Examining food purchase behavior and food values during the COVID-19 pandemic. Applied Economic Perspectives and Policy. 2021;43(1):58-72. http://dx.doi.org/10.1002/aepp.13118

Marin G, Gamba RJ. A new measurement of acculturation for Hispanics: The Bidimensional Acculturation Scale for Hispanics (BAS). Hispanic Journal of Behavioral Sciences. 1996;18(3):297-316. http://dx.doi.org/10.1177/07399863960183002

Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754. — View Citation

Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2. — View Citation

Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3. — View Citation

Sarkar U, Schillinger D, Lopez A, Sudore R. Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265-71. doi: 10.1007/s11606-010-1552-1. Epub 2010 Nov 6. — View Citation

Thompson FE, Midthune D, Kahle L, Dodd KW. Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms. J Nutr. 2017 Jun;147(6):1226-1233. doi: 10.3945/jn.116.246058. Epub 2017 May 10. — View Citation

Zuazagoitia A, Montoya I, Grandes G, Arietaleanizbeascoa MS, Arce V, Martinez V, Sanchez M, Sanchez A. Reliability and validity of the 7-day Physical Activity Recall interview in a Spanish population. Eur J Sport Sci. 2014;14 Suppl 1:S361-8. doi: 10.1080/17461391.2012.705332. Epub 2012 Jul 25. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HgbA1c	Study staff will gather fingerstick blood samples for HgbA1c.	Baseline through 12 months post-enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Environmental Influences on Child-wide Health Outcomes (ECHO). COVID-19 Questionnaire - Adult Primary Version. ECHO-wide Cohort Version 01.30. April 9, 2020. Published 2020.
•   Tuft University Friedman School of Nutrition Science & Policy. Public Impact Initiative: Food is Medicine. Resources Page. Accessed April 20, 2023.