The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.
The primary objective of this study is to test the hypothesis that educating hypertensive chronic kidney disease (CKD) stage 3 and 4 patients on the benefit of a whole food plant based (WFPB) diet in the context of a 15-day educational program ("Jumpstart program") will lead to improved blood pressure control and will not increase rates of hyperkalemia. Other objectives: A) To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall. B) To test the effect of the Jumpstart program on other important outcomes in CKD in the following domains: 1. Body composition such as weight and body mass index (BMI). 2. Quality of life. 3. Laboratory tests including- serum levels of sodium, bicarbonate, chloride, Blood urea nitrogen, creatinine, calcium, phosphorus, magnesium, albumin, parathyroid hormone, fibroblast growth factor 23, lipids, C-reactive protein and erythrocyte sedimentation rate. C) To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Jumpstart educational program: https://www.rochesterlifestylemedicine.com/about-community-jumpstart/
Clinical Research Center of the University of Rochester Medical Center
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Mean change in systolic blood pressure
Unit of measurement - mm Hg
Time frame: Baseline to day 15
Mean change in diastolic blood pressure
Unit of measurement - mm Hg
Time frame: Baseline to day 15
Mean change in potassium levels
Unit of measurement - mEq/L
Time frame: Baseline to day 15
Proportion of participants developing hyperkalemia
Percentage
Time frame: Day 15
Mean Change in energy/day
Unit of measurement - kcal/day. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in energy/kg of body mass
Unit of measurement - kcal/kg/day. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
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Time frame: Baseline to day 15
Mean change in total fat
Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in % calories from fat
Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in % calories from carbohydrates
Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in % calories from protein
Unit of measurement - Percentage. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in Animal protein
Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in Vegetable protein
Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in cholesterol
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in Total dietary fiber
Unit of measurement - grams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in Total fiber per 1000 kcal
Unit of measurement - Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in calcium
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in phosphorous
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in magnesium
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in sodium
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in potassium
Unit of measurement - milligrams. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in body mass
Unit of measurement - kilograms. Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in body mass index
Unit of measurement - kg/m². Subjects completed a 3-day food record prior to intervention and during Jumpstart (or equivalent time for controls). Participants were given a recording form, and verbal and written instructions to record relevant details for all foods and beverages consumed. Portion size was estimated, using food visual aids, or measured, using weight scales or volume measures. A research dietitian (NW) provided the food record instruction and reviewed the completed records with participants to increase the quality of the report. The food record data was then entered into the Nutrition Data System for Research (NSDR, Nutrition Coordinating Center, University of Minnesota, Twin Cities) for calculation of nutrient intake.
Time frame: Baseline to day 15
Mean change in sodium measured in blood
Unit of measurement - mEq/L
Time frame: Baseline to day 15
Mean change in chloride measured in blood
Unit of measurement - mEq/L
Time frame: Baseline to day 15
Mean change in bicarbonate measured in blood
Unit of measurement - mEq/L
Time frame: Baseline to day 15
Mean change in blood urea nitrogen (BUN) measured
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in creatinine measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in glucose measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in calcium measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in phosphorous measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in parathyroid hormome (PTH) measured in blood
Unit of measurement - pg/mL
Time frame: Baseline to day 15
Mean change in albumin measured in blood
Unit of measurement - pg/mL
Time frame: Baseline to day 15
Mean change in magnesium measured in blood
Unit of measurement - mEq/L
Time frame: Baseline to day 15
Mean change in erythrocyte sedimentation rate (ESR) measured in blood
Unit of measurement - mm/hr
Time frame: Baseline to day 15
Mean change in fibroblast growth factor (FGF)-23 measured in blood
Unit of measurement - RU/ml
Time frame: Baseline to day 15
Mean change in total cholesterol measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in low density lipoprotein (LDL) measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in high density lipoprotein (HDL) measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in triglycerides measured in blood
Unit of measurement - mg/dl
Time frame: Baseline to day 15
Mean change in 8-isoprostane measured in urine
Unit of measurement - (ng/mg of creat)/kg
Time frame: Baseline to day 15
Mean change in symptoms
Higher scores indicate better health. Scores are transformed linearly to 0-100 range. The symptom list assesses the extent of bother (not at all, somewhat, moderately, very much, extremely) during the last 30 days in terms of issues particularly relevant to patients with kidney disease including soreness in muscles, pain (joint,back, chest), headaches, cramps during dialysis, bruising, itchy skin, shortness of breath, dizziness, lack of appetite, excessive thirst, numbness in hands or feet, trouble with memory, blurred vision, nausea, or other problems with the access site.
Time frame: Baseline to day 15
Mean change in effects of kidney disease
Higher scores indicate better health. Scores are transformed linearly to 0-100 range. Effects of kidney disease on daily life were assessed using the same five-point response scale used for the symptom/problem list and included restrictions on fluid and dietary intake, and impact on work, carrying out family responsibilities, travel, lifting objects, personal appearance, and time available to get things done.
Time frame: Baseline to day 15
Mean change in burden of kidney disease
Higher scores indicate better health. Scores are transformed linearly to 0-100 range. The burden of kidney disease scale assesses perceptions of frustration and interference of kidney disease in one's life using a definitely true to definitely false response scale (interferes too much with life, too much time spent dealing with it, feel frustrated dealing with it, feel like a burden on family).
Time frame: Baseline to day 15
Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite
Higher scores indicate better health. Scores are transformed linearly to 0-100 range. Physical composite includes questions on how you feel about your physical health. In the survey, participants are asked if they could do things like climb stairs, move a table, or push a vacuum. How well they think they feel physically is a key measure of their health.
Time frame: Baseline to day 15
Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite
Higher scores indicate better health. Scores are transformed linearly to 0-100 range. Mental composite includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities.
Time frame: Baseline to day 15