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| Name | Class |
|---|---|
| Harris Health | UNKNOWN |
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This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.
This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the likelihood of kidney injury progression.
The program components were design to reduce barriers to a) eating healthier, kidney-friendly foods through the direct provision of fruits and vegetables, grocery store e-gift cards, kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the role of healthy eating in slowing its progression through educational materials; and c) social connection through empathetic relational phone calls and SMS texts from a dedicated "Health Partner".
Over a period of 6 months (26 weeks), participants randomized to the intervention arm will receive:
Researchers will see if participation in the program (intervention) reduces markers of kidney injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet (particularly fruits and vegetables intake) and mental health when compared to usual care (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Intervention + usual care | Experimental |
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| Arm 2: Educational materials + usual care | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. Welcome package | Behavioral | At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes:
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| Measure | Description | Time Frame |
|---|---|---|
| Urine albumin:creatinine ratio (UACR) | Marker of kidney damage and a useful predictor of cardiovascular (CV) events in adults. Uses spot urine to estimate 24-hour urine albumin excretion. UACR > 30 mg/g indicates kidney damage. | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Finger stick point-of-care portable device. Measures the average blood sugar levels over the past 3 months with a result in %. Higher A1C levels indicate poorer glycemic control and higher risk of diabetes complications. | Baseline, 3 months, 6 months |
| Blood pressure (systolic/diastolic) |
| Measure | Description | Time Frame |
|---|---|---|
| Social engagement as measured by the Lubben Social Network scale 6-item | Self-administered. The LSNS-6 is a self-report measure of social engagement with family and friends. The sum of the all items yields a total score that ranges between 0 and 30, with a higher score indicating more social engagement. | Baseline, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Mulligan, MA | Contact | 512-522-4349 | Courtney.Mulligan@austin.utexas.edu | |
| Nicole Clark, MBA | Contact | 210-316-5443 | nicole.clark@austin.utexas.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maninder Kahlon, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris Health System's Outpatient Center | Recruiting | Houston | Texas | 77026 | United States | |
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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 | Sep 12, 2023 |
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Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.
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Research staff responsible for biomedical data collection at the sites are blinded to the participant's allocation group. Surveys are primarily self-administered on an electronic mobile device (e.g., tablet, laptop). For participants who require help reading and/or using the device, survey data will be collected via structured interview.
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| 2. Welcome information (phone or text) | Behavioral | Those allocated to the intervention arm will receive a welcome call from the Program Staff to provide further details and expectations about the program (such as delivery details and schedule). Those allocated to the control arm will receive an SMS text that informs them of their arm allocation, what to expect and a phone number to call for questions. |
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| 3. Produce delivery + Recipes customized to produce | Behavioral |
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| 4. E-gift cards to a grocery store of choice | Behavioral | Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency:
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| 5. Personalized practical & emotional support through a dedicated health partner | Behavioral |
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Direct measurement with automatic blood pressure cuff. |
| Baseline, 3 months, 6 months |
| Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10 | 30-day food frequency questionnaire (screener) that asks for frequency of intake in the past month (per month, per week, or per day) of 28 items such as cereal, red meat, fruits and vegetables. This study includes four food items linked to kidney health (and mostly acid-inducing): eggs, chicken/turkey, fish, and cheese. Questions are asked in the same fashion as the other questions in the tool. | Baseline, 3 months, 6 months |
| Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption | Changes in diet quality will be measured by obtaining individual mean dietary intake from the Dietary Screener Questionnaire, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported per fruits and vegetables as cup equivalents/day. | Baseline, 3 months, 6 months |
| Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7) | Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms). | Baseline, 3 months, 6 months |
| Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8) | Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). The sum of responses to each item yields a total score that screens for depression and its severity: not depressed (0-2), mild (3-5), moderate (6-8), and severe (9-12). | Baseline, 3 months, 6 months |
| Loneliness measured by scores on the 3-item UCLA Loneliness Scale | Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness. | Baseline, 3 months, 6 months |
| Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire |
Self-administered. Answers are on a 0-10 sliding scale, except for one open-ended ranking question. Increases in item scores represent linear increases in the dimension measured. It contains 9 questions addressing the individual's cognitive perceptions, control over illness, beliefs about the effectiveness of treatment, experience of symptoms and emotional aspects. To better tailor it to the study population, "illness" was replaced by "kidney problem". And one question about perceived impact of food on disease was added to tailor it to the intervention. |
| Baseline, 6 months |
| General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12) | Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health. | Baseline, 6 months |
| Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form | Self-administered. Self-report assessment of access to food in the past 30 days. The sum of affirmative responses to the six questions in the module yields the household's raw score on the scale. Scores can range from 0 to 6, with higher scores indicating lower food security. | Baseline, 6 months |
| Estimated Glomerular Filtration Rate (eGFR) | Obtained from Electronic Health Records. Any lab result available from 18 months prior to and 15 month post enrollment date will be obtained for study participants. | As available 18 months before enrollment in the study and 15 months after study participation ends |
| Changes in diet quality as estimates of individual mean dietary intake and frequency of dairy consumption | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Food group of dairy is reported as cup equivalents/day. | Baseline, 3 months, 6 months |
| Changes in diet quality as estimates of individual mean dietary intake of added sugars | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported added sugars as teaspoon equivalents/day. | Baseline, 3 months, 6 months |
| Changes in diet quality as estimates of individual mean dietary intake and frequency of whole grains | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported whole grains as ounce equivalents/day. | Baseline, 3 months, 6 months |
| Changes in diet quality as estimates of individual mean dietary intake of fiber | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported fiber as g/day. | Baseline, 3 months, 6 months |
| Changes in diet quality as estimates of individual mean dietary intake of calcium | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Reported calcium as mg/day. | Baseline, 3 months, 6 months |
| Changes in diet quality as frequency of red and processed meat consumption | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. And reported red meat and processed meat as frequencies (times per day). | Baseline, 3 months, 6 months |
| Changes in frequency and intake of eggs | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its acid-inducing properties in chronic kidney disease. Reported as frequencies only (times per day) and amount. | Baseline, 3 months, 6 months |
| Changes in frequency and intake of chicken/turkey | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its acid-inducing properties in chronic kidney disease. Reported as frequencies only (times per day). | Baseline, 3 months, 6 months |
| Changes in frequency and intake of fish | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Added for its association with reduced CVD risk. Reported as frequencies only (times per day). | Baseline, 3 months, 6 months |
| Changes in type of cheese consumption when reported | Changes in diet quality will be measured by obtaining individual mean dietary intake, as well as frequency of food group consumption, as per analytical instructions in the National Cancer Institute, using USDA nutrient database. Soft vs. hard cheese types added for the acid-inducing properties of hard cheese in chronic kidney disease. Reported as type associated with dairy consumption. | Baseline, 3 months, 6 months |
| Harris Health System's Martin Luther King Jr. Health Center |
| Recruiting |
| Houston |
| Texas |
| 77047 |
| United States |
| Harris Health System's Smith Clinic | Recruiting | Houston | Texas | 77054 | United States |
| Oct 10, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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