Trial Outcomes & Findings for Five, Plus Nuts and Beans for Kidneys (NCT NCT03299816)
NCT ID: NCT03299816
Last Updated: 2023-06-22
Results Overview
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
Baseline, 4 months
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Coaching DASH Group (C-DASH)
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Phase 1: 4-month Intervention Period
STARTED
|
70
|
72
|
|
Phase 1: 4-month Intervention Period
COMPLETED
|
69
|
72
|
|
Phase 1: 4-month Intervention Period
NOT COMPLETED
|
1
|
0
|
|
Phase 2: 12-month Follow-up Period
STARTED
|
52
|
56
|
|
Phase 2: 12-month Follow-up Period
COMPLETED
|
49
|
53
|
|
Phase 2: 12-month Follow-up Period
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Coaching DASH Group (C-DASH)
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Phase 1: 4-month Intervention Period
Withdrawal by Subject
|
1
|
0
|
|
Phase 2: 12-month Follow-up Period
Withdrawal by Subject
|
1
|
0
|
|
Phase 2: 12-month Follow-up Period
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Five, Plus Nuts and Beans for Kidneys
Baseline characteristics by cohort
| Measure |
Coaching DASH Group (C-DASH)
n=70 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=72 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Baseline Urinary albumin-to-creatine (ACR)
|
99.8 mg/g
n=5 Participants
|
98.8 mg/g
n=7 Participants
|
99.5 mg/g
n=5 Participants
|
|
Systolic Blood Pressure
|
128.1 mmHg
STANDARD_DEVIATION 14.4 • n=5 Participants
|
130.8 mmHg
STANDARD_DEVIATION 12.8 • n=7 Participants
|
129.4 mmHg
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Diastolic Blood Pressure
|
72.3 mmHg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
74.4 mmHg
STANDARD_DEVIATION 11.2 • n=7 Participants
|
73.3 mmHg
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Diabetes (Self-report)
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Urinary albumin-to-creatine ratio category
<30 mg/g
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Urinary albumin-to-creatine ratio category
30 to <300 mg/g
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Urinary albumin-to-creatine ratio category
>=300 mg/g
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 monthsPopulation: For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study and 2 were lost to follow-up.
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=67 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=72 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Urinary Albumin Excretion From Baseline to 4 Months
|
-28.6 mg/g
Standard Error 12.0
|
-5.6 mg/g
Standard Error 11.6
|
SECONDARY outcome
Timeframe: Baseline,4 monthsPopulation: For C-DASH, 4 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 1 was due to measurement error. For S-DASH, 5 participants were excluded: 4 were due to measurement error, and 1 due to an out-of-range baseline reading.
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=66 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=67 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 4 Months
|
-1.4 mm Hg
Standard Error 1.8
|
0.9 mm Hg
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline, end of study (approximately 12 months)Population: For C-DASH, 9 participants were excluded from analysis: 1 withdrew from Phase 2 of the study, 3 were lost to follow-up, 1 due to measurement error, 1 moved out of state, and 3 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 12 participants were excluded: 4 were lost to follow-up, 5 due to measurement error, and 3 were restricted from in-person data collection due to the pandemic.
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=43 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=44 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 12 Months
|
1.5 mm Hg
Standard Error 2.3
|
-1.6 mm Hg
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Baseline, end of study (approximately 12 months)Population: For C-DASH, 7 participants were excluded from analysis: 1 withdrew during Phase 2 of the study, 2 were lost to follow-up, and 4 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 8 participants were excluded: 3 were lost to follow-up, 1 sample was lost due to lab error, and 4 were restricted due to the pandemic.
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=45 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=48 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Urinary Albumin Excretion From Baseline to 12 Months
|
-11.5 mg/g
Standard Error 14.1
|
-1.4 mg/g
Standard Error 13.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 monthPopulation: For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study, and 2 were lost to follow-up. For S-DASH, 1 participant was excluded from analysis due to an invalid urine sample.
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=67 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=71 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Urinary Albumin Excretion From Baseline to 1 Month
|
-14.8 mg/g
Standard Error 10.1
|
-19.6 mg/g
Standard Error 9.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 monthPopulation: For C-DASH, 7 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 4 were due to measurement error. For S-DASH, 4 participants were excluded: 3 were due to measurement error, and 1 due to an out-of-range at baseline reading.
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Outcome measures
| Measure |
Coaching DASH Group (C-DASH)
n=63 Participants
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=68 Participants
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 1 Month
|
-1.1 mm Hg
Standard Error 1.6
|
-0.3 mm Hg
Standard Error 1.5
|
Adverse Events
Coaching DASH Group (C-DASH)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Self-Shopping DASH Group (S-DASH)
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coaching DASH Group (C-DASH)
n=70 participants at risk
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=72 participants at risk
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/70 • Number of events 4 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Surgical and medical procedures
Cardiac Catheterization
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Injury, poisoning and procedural complications
Angioneurotic edema
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Renal and urinary disorders
Acute kidney failure
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Vascular disorders
Cerebral infarction, unspecified
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Gastrointestinal disorders
Chronic pancreatitis
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Infections and infestations
COVID-19
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Endocrine disorders
Diabetes mellitus with ketoacidosis
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Nervous system disorders
Mechanical complication of ventricular intracranial (communicating) shunt
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Moderate persistent asthma with (acute) exacerbation
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Vascular disorders
Angina pectoris
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Vascular disorders
Aortic aneurysm and dissection
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Gastrointestinal disorders
Chest pain, unspecified
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Vascular disorders
Non-ST elevation myocardial infarction
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Blood and lymphatic system disorders
Thrombophilia
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Musculoskeletal and connective tissue disorders
Thrombotic microangiopathy
|
0.00%
0/70 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
1.4%
1/72 • Number of events 2 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Vascular disorders
Type 2 Subsequent non-ST elevation myocardial infarction
|
1.4%
1/70 • Number of events 1 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
0.00%
0/72 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
Other adverse events
| Measure |
Coaching DASH Group (C-DASH)
n=70 participants at risk
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
|
Self-Shopping DASH Group (S-DASH)
n=72 participants at risk
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
|
|---|---|---|
|
Vascular disorders
Hypertensive Urgency
|
4.3%
3/70 • Number of events 4 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
13.9%
10/72 • Number of events 14 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
7/70 • Number of events 9 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
8.3%
6/72 • Number of events 6 • The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
|
Additional Information
Deidra C. Crews, MD, ScM
Johns Hopkins University School of Medicine
Phone: 410-502-0518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place