Trial Outcomes & Findings for Intervention to Reduce Dietary Sodium in Hemodialysis (NCT NCT01125202)

NCT ID: NCT01125202

Last Updated: 2017-08-15

Results Overview

Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.

Recruitment status

COMPLETED

Study phase

Target enrollment

179 participants

Primary outcome timeframe

Baseline

Results posted on

2017-08-15

Participant Flow

Participants were recruited from 17 dialysis centers, from the 3 corporate chains, between September 2009 and September 2012. Of the 848 HD patients available, 257 were eligible, 191 consented, 185 provided baseline data, 179 were randomized, and 160 (89.4%) completed the final 16-week measurement assessment.

Participant milestones

Participant milestones
Measure	Intervention Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.	Attention Control Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Overall Study STARTED	93	86
Overall Study COMPLETED	81	79
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention to Reduce Dietary Sodium in Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=93 Participants Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.	Attention Control n=85 Participants Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.	Total n=178 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 13.5 • n=5 Participants	60.8 years STANDARD_DEVIATION 13.4 • n=7 Participants	59.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	44 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants	83 Participants n=7 Participants	174 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	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	51 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	85 participants n=7 Participants	178 participants n=5 Participants
Etiology of ESRD Diabetes	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Etiology of ESRD Hypertension	19 Participants n=5 Participants	30 Participants n=7 Participants	49 Participants n=5 Participants
Etiology of ESRD Glomerular disease	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Etiology of ESRD Polycystic disease	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Etiology of ESRD Neoplasms/tumors	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Etiology of ESRD Other	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.

Outcome measures

Outcome measures
Measure	Intervention n=88 Participants Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.	Attention Control n=80 Participants Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Time Specific Interdialytic Weight Gain (Baseline)	1.2 kg/day Standard Deviation 0.6	1.2 kg/day Standard Deviation 0.5

PRIMARY outcome

Timeframe: 8 weeks

Population: Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.

Outcome measures

Outcome measures
Measure	Intervention n=81 Participants Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.	Attention Control n=80 Participants Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Time Specific Interdialytic Weight Gain (8 Weeks)	1.1 kg/day Standard Deviation 0.6	1.2 kg/day Standard Deviation 0.5

PRIMARY outcome

Timeframe: 12 weeks

Population: Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.

Outcome measures

Outcome measures
Measure	Intervention n=80 Participants Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.	Attention Control n=79 Participants Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Time Specific Interdialytic Weight Gain (12 Weeks)	1.2 kg/day Standard Deviation 0.5	1.2 kg/day Standard Deviation 0.5

PRIMARY outcome

Timeframe: 16 weeks

Population: Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.