Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
NCT07918508, Not applicable, Not yet recruiting, Florida International University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health | ClinicalTrials.gov |
| NCT number | NCT07918508 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Florida International University | ClinicalTrials.gov |
| Conditions | Hypertension (HTN), CKD - Chronic Kidney Disease, Cardio-Renal Syndrome, Food Insecurity, Type 2 Diabetes | ClinicalTrials.gov |
| Interventions | INTEGRATE-CHW, Usual Care | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Nutrition Self-Efficacy Scale Score at Week 12 | Baseline and Week 12 | 5-item Nutrition Self-Efficacy Scale, which measures confidence in maintaining healthy eating behaviors despite common barriers. Interviewer-administered in English or Spanish. | ClinicalTrials.gov |
| Primary | Change From Baseline in Short Food Literacy Questionnaire (SFLQ) Score at Week 12 | Baseline and Week 12 | 12-item Short Food Literacy Questionnaire (SFLQ), which evaluates the ability to interpret nutrition information, read labels, and make balanced food choices. Interviewer-administered in English or Spanish. | ClinicalTrials.gov |
| Primary | Change From Baseline in Healthy Eating Index-2020 (HEI-2020) Total Score at Week 12 | Baseline and Week 12 | Healthy Eating Index-2020 (HEI-2020) total score, derived from two 24-hour dietary recalls. | ClinicalTrials.gov |
| Secondary | Change From Baseline in USDA Six-Item Food Security Module Score at Week 12 | Baseline and Week 12 | USDA six-item food security module. | ClinicalTrials.gov |
| Secondary | Change From Baseline in HbA1c (%) at Week 12 | Baseline and Week 12 | Glycated hemoglobin (%), extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Systolic Blood Pressure (mmHg) at Week 12 | Baseline and Week 12 | Systolic blood pressure (mmHg), extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Diastolic Blood Pressure (mmHg) at Week 12 | Baseline and Week 12 | Diastolic blood pressure (mmHg), extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Body Mass Index (kg/m²) at Week 12 | Baseline and Week 12 | Body mass index (kg/m²), extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Lipid Profile at Week 12 | Baseline and Week 12 | Lipid profile, extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in eGFR (mL/min/1.73 m²) at Week 12 | Baseline and Week 12 | eGFR (mL/min/1.73 m²), extracted from the electronic medical record. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Urinary Albumin-to-Creatinine Ratio (mg/g) at Week 12 | Baseline and Week 12 | uACR (mg/g), extracted from the electronic medical record; log-transformed and reported as ratios of geometric means. | ClinicalTrials.gov |
| Other | Feasibility: Proportion of Eligible Patients Who Enroll and Complete Follow-up | Enrollment through Week 12 follow-up | Proportion of eligible patients who enroll and complete follow-up. | ClinicalTrials.gov |
| Other | Reach: Demographic Comparability of Enrolled Participants With the Clinic's CKM Population | Enrollment period | Demographic comparability between enrolled participants and the clinic's CKM population. | ClinicalTrials.gov |
| Other | Fidelity: Percentage of CHW Sessions Meeting All Required Elements | Weeks 1-12 | Percentage of CHW sessions meeting all required elements, assessed through CHW session checklists, direct observation, and periodic audio review. | ClinicalTrials.gov |
| Other | Acceptability: Theoretical Framework of Acceptability (TFA) Survey Score | Week 12 | Theoretical Framework of Acceptability (TFA) survey completed by intervention participants. | ClinicalTrials.gov |
| Other | Adoption: Proportion of RDs, CHWs, and Food Partners Delivering the Program as Intended | Up to 21 months (intervention delivery period) | Proportion of participating registered dietitians, CHWs, and food partners delivering the program as intended. | ClinicalTrials.gov |
| Other | Incremental Cost per Participant (US Dollars) | 12 weeks | Estimated from staff time, session duration, and supply costs, with cost per unit outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)