Brief Summary
This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.
Brief Title
Multicultural Healthy Diet in Chronic Kidney Disease
Detailed Description
This is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. The study will recruit 20 adult participants with chronic kidney disease (CKD) from nephrology clinics in the Bronx. The diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with CKD. The investigative team will assess whether the diet is feasible, acceptable, and safe in patients with CKD through dietary intake assessments, questionnaires and serum biomarkers. Information from study will help inform the study design and intervention of a future large-scale, study aimed at improving CKD outcomes. The clinical site for the proposed study is at the Albert Einstein College of Medicine and Montefiore Medical Center.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* CKD stage 3 (estimated glomerular filtration rate (GFR) \< 60 - \>30 ml/min/1.73m2)
* Residency in the Bronx
* English or Spanish speaking
* Provide written informed consent
Exclusion Criteria:
* History of hyperkalemia, or baseline serum potassium (K) \> 4.8
* CKD stage 4 or higher (eGFR \<30 ml/min/1.73 m\^2)
* Unwillingness to make dietary changes
* History of kidney transplant
* Poorly controlled diabetes (HbA1c \>9%) or insulin use
* Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities
* Age ≥18 years
* CKD stage 3 (estimated glomerular filtration rate (GFR) \< 60 - \>30 ml/min/1.73m2)
* Residency in the Bronx
* English or Spanish speaking
* Provide written informed consent
Exclusion Criteria:
* History of hyperkalemia, or baseline serum potassium (K) \> 4.8
* CKD stage 4 or higher (eGFR \<30 ml/min/1.73 m\^2)
* Unwillingness to make dietary changes
* History of kidney transplant
* Poorly controlled diabetes (HbA1c \>9%) or insulin use
* Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities
Inclusion Criteria
Inclusion Criteria:
* Age ≥18 years
* CKD stage 3 (estimated glomerular filtration rate (GFR) \< 60 - \>30 ml/min/1.73m2)
* Residency in the Bronx
* English or Spanish speaking
* Provide written informed consent
* Age ≥18 years
* CKD stage 3 (estimated glomerular filtration rate (GFR) \< 60 - \>30 ml/min/1.73m2)
* Residency in the Bronx
* English or Spanish speaking
* Provide written informed consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT05504850
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12753
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease
Primary Outcomes
Outcome Description
Change in dietary inflammatory score (Dietary intake will be scored using a dietary inflammation index). The scores at baseline (pre-intervention) will be compared to scores at 2 months. A lower score indicates a more anti-inflammatory dietary pattern. The intervention will be considered feasibile if ≥65% participants have a 2-point or more reduction from their baseline dietary inflammation score.
Outcome Measure
Feasibility of dietary intervention
Outcome Time Frame
2 months post baseline
Outcome Description
This will be assessed using questionnaires and structured interviews about the dietary intervention
Outcome Measure
Acceptability
Outcome Time Frame
2 months post baseline
Secondary Ids
Secondary Id
K23DK124644-01A1
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tanya Johns
Investigator Email
tjohns@montefiore.org
Investigator Phone
718-430-8913