The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease
- Sponsor
- Montefiore Medical Center
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Feasibility of dietary intervention
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
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 approximately 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •CKD stage 3 (estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m\^2 to \< 60 ml/min/1.73m\^2)
- •Residency in the Bronx
- •Sufficient hearing, vision, and proficiency in English or Spanish to comprehend dietary counseling and low-level printed educational materials
- •Provide written informed consent
Exclusion Criteria
- •History of hyperkalemia, or baseline serum potassium (K) \> 4.8
- •CKD stage 4 or higher estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73 m\^2
- •Unwillingness/inability to make dietary changes or if primarily interested in weight loss as judged by discussion with the participant
- •History of kidney transplant
- •Poorly controlled diabetes (HbA1c \>9%) or insulin use
- •Any severe chronic illness, low literacy, or other serious condition that precludes making dietary changes and requires strict dietary restrictions or completion of study activities
- •Plans to relocate out of New York City in the next 2 months
- •Visual, auditory, or motor impairment that precludes completion of the assessments
Outcomes
Primary Outcomes
Feasibility of dietary intervention
Time Frame: From baseline to 2 months post baseline
Feasibility of the dietary intervention will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index Diet (E-DII®) platform. The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. The EE-DII® is a scientific tool that quantifies the potential of a person's diet to cause inflammation, adjusting for total calorie intake for better accuracy. It assigns higher (positive) scores to pro-inflammatory diets (processed meats, sugary drinks) and lower (negative) scores to anti-inflammatory diets (leafy greens, fruits, fish). For this study scores at baseline (pre-intervention) will be compared to scores at 2 months using the E-DII®. The intervention will be considered feasible if ≥ 65% participants have a 2-point or more reduction from their baseline dietary inflammation score.
Acceptability of dietary intervention
Time Frame: 2 months post baseline
Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire. Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing, whether they liked the diet, in general, and liked using herbs/spices that they had not used before; and would recommend the diet to family/friends. Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree). The number/percentage of participants selecting each category will be tabulated.