Trial · NCT07911969
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
NCT07911969, Not applicable, Not yet recruiting, Baylor College of Medicine
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease. Trials, record NCT07911969. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
- NCT number
- NCT07911969
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Baylor College of Medicine
- Conditions
- End Stage Kidney Disease (ESKD)
- Interventions
- Culinary Medicine Intervention, Pre-prepared MTMs
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility - Recruitment | through study completion, an average of 1 year | Recruitment feasibility will be assessed by staff logs. Records will include number of families contacted, the number who qualified; the number who did not qualify and the reasons; and of those who qualified - number who agreed to participate; the number who did not participate and reasons; and the number who completed and return enrollment package and were enrolled. CRITERION: recruitment goals are met (n=30 parent-child dyads). Investigators will determine if this criterion was met by comparing the number of families enrolled to the criterion. |
| Primary | Feasibility - Participation in intervention activities | up to 12 weeks of intervention | Participation in intervention activities will be assessed through REDCap surveys. Culinary medicine (CM) participants will receive weekly text messages linking to surveys assessing session attendance, activity participation, and meal feedback. Participants receiving pre-prepared medically tailored meals (MTMs) will scan QR codes on meal boxes to complete meal-specific feedback surveys. Pre- and post-meal photographs will help estimate meal consumption and assess intervention adherence. Criteria: CM participants will achieve ≥75% adherence to intervention activities, calculated as the average number of activities completed divided by the total activities offered, based on session logs and participant feedback. For the pre-prepared MTM group, the target is consumption of ≥70% of meals provided by the enrolled child, assessed through participant feedback and meal photographs. |
| Primary | Feasibility - Attrition | Baseline to 12 weeks | Attrition rate is defined as the number of participants who did not complete the intervention (i.e. weekly CM sessions and MTMs) and all data collection activities (i.e. baseline, post intervention). It will be calculated by dividing the total number of participants who completed these activities by the total number providing informed consent. CRITERION: overall attrition rate is \<10%. Investigators will determine if this criterion was met by dividing the number of families who completed all intervention and data collection activities by the total number of families enrolled and comparing the result to the criterion. |
| Primary | Acceptability - Program satisfaction | At 12 weeks from baseline | Program satisfaction will be assessed at post intervention with a 10-item measure of satisfaction. Items will be rated using a 2-point Likert scale (no, yes). Scores can range from 10-20, with higher scores representing higher satisfaction. CRITERION: \>80% for both children and parents. Investigators will determine if this criterion was met by determining the average satisfaction score for parents and children separately and comparing the results to the criterion. |
| Primary | Feasibility - Data completeness | Baseline and at 12 weeks | Data completeness is defined as the percentage of participants with complete self-report data at all assessment points (baseline, post intervention). These data will be obtained from the missing data in data files. CRITERION: \>80% of data are collected at baseline and post intervention. Investigators will determine if this criterion was met by calculating the number of families with complete data and comparing it to the criterion. |
| Primary | Acceptability - Feedback interviews | At 12 weeks from baseline | Post intervention interviews with parents and children will seek to obtain a better understanding of the acceptability of the intervention, participants' experiences, preferences, and challenges encountered during the program. |
| Secondary | Child's metabolic profile | Up to 12 weeks from baseline | The EMR will be queried to obtain laboratory results including serum sodium, potassium, phosphorus, parathyroid hormone (PTH) and protein catabolic rate (nPCR) performed monthly as standard of care in the outpatient dialysis unit. Blood pressure information will be collected weekly on a day where the patient has not received hemodialysis in 48 hours (for the HD cohort). Pre and post dialysis weights would be collected weekly on day where the patient has not received hemodialysis in 48 hours (HD cohort). Dry weights would also be collected to assess fluid overload. Medication lists will be reviewed and information on number of antihypertensive medications and use of short acting anti-hypertensive medication collected. Information on phosphate binder use will also be collected. |
| Secondary | Diet quality | Baseline and at 12 weeks | To assess usual dietary intake, investigators will obtain two 24-hour dietary recalls (1 week day; 1 weekend day) over the telephone at each data collection (baseline, post-intervention). Investigators will obtain the dietary recalls (24hdr) by telephone on non- consecutive days at each observation. Children 8 years and older can give a reasonably accurate self-report of intake, For younger children, parent-reported dietary recalls will be conducted to ensure data validity. Dietary intake data gathered by interview is governed by a multiple-pass interview approach. Multiple 24-hour dietary recalls are considered the gold-standard for dietary assessment, and in addition to the calories and servings consumed, will allow us to compute a Healthy Eating Index (HEI-2015), a measure of diet quality. The recalls will be collected by trained staff using Nutrition Data System for Research (NDS-R, 2019 version). |
| Other | Demographics | Baseline | Parents will complete a standard demographic survey assessing parent, child, and family characteristics at baseline. These will include: age of the child, date of birth, sex, school attendance, grade level, race, ethnicity, total number of people in the household - adults and children, language spoken at home, marital status, employment status, education, total annual household income, housing status, transportation, zip code of residence. Socio-demographic measures were obtained from the TCH EMR (age, gender, race/ethnicity). Any discrepancies in the responses will be clarified with the participant. For this study, the item assessing parent and child sex will be revised to be more gender inclusive: "What gender do you identify with (fill in response)" and "What sex was documented on your/your child's original birth certificate? (response options - male/female). |
| Other | Food security | Baseline | Parents will complete the 18-item USDA household food security questionnaire at baseline. It contains a series of questions about conditions and behaviors occurred at any time during the previous 12 months that characterize households when they are having difficulty meeting basic food needs. The series includes three questions about food conditions of the household, seven about food conditions of adults in the household, and an additional eight questions about children's food conditions. Participants will be categorized into food secure and food insecure depending on their responses. Food insecurity status was also obtained at baseline from the TCH EMR. TCH screens for food insecurity status system-wide using the two-item Hunger Vital Sign measures. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| R01DK141577 | Comparative feasibility and effectiveness of medically tailored meals approaches for pediatric end stage kidney disease | DAVE, JAYNA MARKAND; ONUGHA, ELIZABETH ANYAEGBU | BAYLOR COLLEGE OF MEDICINE | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT07911969/registered