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Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial.
Liu, S, Tanaka, R, Barr, S, Nolan, RP
Patient education and counseling. 2020;(3):635-641
Abstract
OBJECTIVE 1) Evaluate the efficacy of e-Counseling vs. Control to promote lifestyle behaviors at 4 and 12-month follow-ups, 2) examine whether these behaviors changes were associated with lower blood pressure (BP), and Framingham Risk Index (FRI) at 12-month. METHODS Hypertensive patients (n = 264) were randomized to the e-Counseling or the Control group. Primary trial outcome was BP and secondary outcomes included exercise and diet behaviors. This study presented the results of secondary outcomes. Linear mixed models evaluated treatment effects at 4 and 12-month. Treatment-by-sex exploratory analyses were conducted if no main treatment effect was observed. RESULTS Daily steps significantly improved in e-Counseling vs. Controls at 12-month. Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months. Improvements in steps and dietary sodium were significantly associated with improvements in BP and FRI at 12-month. CONCLUSION This hypertension e-Counseling protocol can promote long-term lifestyle behavior changes. Adherence to the lifestyle behavior change was associated with BP and FRI reduction at 12-month. PRACTICE IMPLICATIONS The hypertension e-counseling protocol has the potential to improve hypertension care and intervention reach.
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Effects of the DASH Diet and Sodium Intake on Bloating: Results From the DASH-Sodium Trial.
Peng, AW, Juraschek, SP, Appel, LJ, Miller, ER, Mueller, NT
The American journal of gastroenterology. 2019;(7):1109-1115
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INTRODUCTION Bloating is one of the most common gastrointestinal complaints. Evidence has linked fiber and sodium to bloating; however, randomized trials examining these diet components are lacking. Here, we used a randomized trial to examine the effects of the high-fiber DASH diet and dietary sodium intake on abdominal bloating. We hypothesized that both the high-fiber DASH diet and higher sodium intake would increase bloating. METHODS The DASH-Sodium trial (1998-1999) randomized healthy adults to a high-fiber (32 g/d) DASH or low-fiber (11 g/d) Western diet (control). On their assigned diet, participants ate 3 sodium levels (50, 100, and 150 mmol/d at 2100 kcal) in 30-day periods in random order, with 5-day breaks between each period. The participants reported the presence of bloating at baseline and after each feeding period. Statistical analyses included log-binomial models to evaluate the risk of bloating. RESULTS Of 412 participants (mean age 48 years; 57% women; 57% black), 36.7% reported bloating at baseline. Regardless of the diet, high sodium intake increased the risk of bloating (risk ratio = 1.27; 95% confidence interval: 1.06-1.52; P = 0.01). The high-fiber DASH diet also increased the risk of bloating over all sodium levels (risk ratio = 1.41; 95% confidence interval: 1.22-1.64; P < 0.001). The effect of high-fiber DASH on bloating was greater in men than in women (P for interaction = 0.001). DISCUSSION Higher dietary sodium increased bloating, as did the high-fiber DASH diet. Although healthful high-fiber diets may increase bloating, these effects may be partially mitigated by decreasing dietary sodium intake. Future research is needed to explore mechanisms by which sodium intake and diet can influence bloating.
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Impact of Moderate Sodium Restriction and Hydrochlorothiazide on Iodine Excretion in Diabetic Kidney Disease: Data from a Randomized Cross-Over Trial.
Binnenmars, SH, Corpeleijn, E, Kwakernaak, AJ, Touw, DJ, Kema, IP, Laverman, GD, Bakker, SJL, Navis, G
Nutrients. 2019;(9)
Abstract
Sodium restriction may potentially reduce iodine intake. This study aimed to determine the effect of sodium restriction (dietary counseling) on 24-h urinary iodine excretion. Diuretics provide an alternative to sodium restriction and are frequently added to sodium restriction, so the effects of hydrochlorothiazide (50 mg daily) and combined therapy were also studied. We performed a post-hoc analysis of a Dutch multi-center, randomized cross-over trial in 45 patients with diabetic kidney disease with a mean age of 65 ± 9 years, mean eGFR of 65 ± 27 mL/min/1.73 m2, median albuminuria of 648 [230-2008] mg/24 h and 84% were male. During regular sodium intake with placebo, mean 24 h urinary sodium and iodine excretion were 224 ± 76 mmol/24 h and 252 ± 94 ug/24 h, respectively (r = 0.52, p < 0.001). Mean iodine excretion did not change significantly if sodium restriction and hydrochlorothiazide were applied separately; mean difference -8 ug/day (95% CI -38, 22; p = 0.6) and 14 ug/day (95% CI -24, 52; p = 0.5), respectively. Combined therapy induced a significant decrease in mean iodine excretion (-37 ug/day; 95% CI -67, -7; p = 0.02), yet this was not seen to a clinically meaningful level. The number of patients with an estimated intake below recommended daily allowances did not differ significantly between the four treatment periods (p = 0.3). These findings show that sodium restriction is not a risk factor for iodine deficiency.
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Relationship of Sodium Intake and Blood Pressure Varies With Energy Intake: Secondary Analysis of the DASH (Dietary Approaches to Stop Hypertension)-Sodium Trial.
Murtaugh, MA, Beasley, JM, Appel, LJ, Guenther, PM, McFadden, M, Greene, T, Tooze, JA
Hypertension (Dallas, Tex. : 1979). 2018;(5):858-865
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Dietary Na recommendations are expressed as absolute amounts (mg/d) rather than as Na density (mg/kcal). Our objective was to determine whether the strength of the relationship of Na intake with blood pressure (BP) varied with energy intake. The DASH (Dietary Approaches to Stop Hypertension)-Sodium trial was a randomized feeding trial comparing 2 diets (DASH and control) and 3 levels of Na density. Participants with pre- or stage 1 hypertension consumed diets for 30 days in random order; energy intake was controlled to maintain body weight. This secondary analysis of 379 non-Hispanic black and white participants used mixed-effects models to assess the association of Na and energy intakes with BP. The relationships between absolute Na and both systolic and diastolic BP varied with energy intake. BP rose more steeply with increasing Na at lower energy intake than at higher energy intake (P interaction<0.001). On the control diet with 2300 mg Na, both systolic and diastolic BP were higher (3.0 mm Hg; 95% confidence interval, 0.2-5.8; and 2.7 mm Hg; 95% confidence interval, 1.0-4.5, respectively) among those with lower energy intake (higher Na density) than among those with higher energy intake (lower Na density). The association of Na with systolic BP was stronger at lower levels of energy intake in both blacks and whites (P<0.001). The association of Na and diastolic BP varied with energy intake only among blacks (P=0.001). Sodium density should be considered as a metric for expressing dietary Na recommendations.
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Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).
Colin-Ramirez, E, Ezekowitz, JA, ,
American heart journal. 2018;:87-96
Abstract
BACKGROUND Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. METHODS The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients. CONCLUSIONS The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
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Rationale, design, and baseline characteristics of the Salt Substitute and Stroke Study (SSaSS)-A large-scale cluster randomized controlled trial.
Neal, B, Tian, M, Li, N, Elliott, P, Yan, LL, Labarthe, DR, Huang, L, Yin, X, Hao, Z, Stepien, S, et al
American heart journal. 2017;:109-117
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Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data.
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Family partnership and education interventions to reduce dietary sodium by patients with heart failure differ by family functioning.
Dunbar, SB, Clark, PC, Stamp, KD, Reilly, CM, Gary, RA, Higgins, M, Kaslow, N
Heart & lung : the journal of critical care. 2016;(4):311-8
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OBJECTIVES Determine if family functioning influences response to family-focused interventions aimed at reducing dietary sodium by heart failure (HF) patients. BACKGROUND Lowering dietary sodium by HF patients often occurs within the home and family context. METHODS Secondary analysis of 117 dyads randomized to patient and family education (PFE), family partnership intervention (FPI) or usual care (UC). Dietary sodium measures were obtained from 3-day food record and 24-h urine samples. RESULTS In the poor family functioning groups, FPI and PFE had lower mean urine sodium than UC (p < .05) at 4 months, and FPI remained lower than UC at 8 months (p < .05). For good family functioning groups, FPI and PFE had lower mean sodium levels by 3-day food record at 4 and 8 months compared to the UC group. CONCLUSION Optimizing family-focused interventions into HF clinical care maybe indicated.
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Impact of Dietary Sodium Restriction on Heart Failure Outcomes.
Doukky, R, Avery, E, Mangla, A, Collado, FM, Ibrahim, Z, Poulin, MF, Richardson, D, Powell, LH
JACC. Heart failure. 2016;(1):24-35
Abstract
OBJECTIVES This study sought to evaluate the impact of sodium restriction on heart failure (HF) outcomes. BACKGROUND Although sodium restriction is advised for patients with HF, data on sodium restriction and HF outcomes are inconsistent. METHODS We analyzed data from the multihospital HF Adherence and Retention Trial, which enrolled 902 New York Heart Association functional class II/III HF patients and followed them up for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/d) and unrestricted (≥2,500 mg/d) groups. Study groups were propensity score matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization. RESULTS Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity matched into sodium restricted (n = 130) and sodium unrestricted (n = 130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.21 to 2.84; p = 0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR: 1.82; 95% CI: 1.11 to 2.96; p = 0.015) and a nonsignificant increase in the rate of cardiac death (HR: 1.62; 95% CI: 0.70 to 3.73; p = 0.257) and all-cause mortality (p = 0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (HR: 5.78; 95% CI: 1.93 to 17.27; p = 0.002). CONCLUSIONS In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management. (A Self-management Intervention for Mild to Moderate Heart Failure [HART]; NCT00018005).
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Moderate dietary sodium restriction added to angiotensin converting enzyme inhibition compared with dual blockade in lowering proteinuria and blood pressure: randomised controlled trial.
Slagman, MC, Waanders, F, Hemmelder, MH, Woittiez, AJ, Janssen, WM, Lambers Heerspink, HJ, Navis, G, Laverman, GD, ,
BMJ (Clinical research ed.). 2011;:d4366
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OBJECTIVE To compare the effects on proteinuria and blood pressure of addition of dietary sodium restriction or angiotensin receptor blockade at maximum dose, or their combination, in patients with non-diabetic nephropathy receiving background treatment with angiotensin converting enzyme (ACE) inhibition at maximum dose. DESIGN Multicentre crossover randomised controlled trial. SETTING Outpatient clinics in the Netherlands. PARTICIPANTS 52 patients with non-diabetic nephropathy. INTERVENTIONS All patients were treated during four 6 week periods, in random order, with angiotensin receptor blockade (valsartan 320 mg/day) or placebo, each combined with, consecutively, a low sodium diet (target 50 mmol Na(+)/day) and a regular sodium diet (target 200 mmol Na(+)/day), with a background of ACE inhibition (lisinopril 40 mg/day) during the entire study. The drug interventions were double blind; the dietary interventions were open label. MAIN OUTCOME MEASURES The primary outcome measure was proteinuria; the secondary outcome measure was blood pressure. RESULTS Mean urinary sodium excretion, a measure of dietary sodium intake, was 106 (SE 5) mmol Na(+)/day during a low sodium diet and 184 (6) mmol Na(+)/day during a regular sodium diet (P<0.001). Geometric mean residual proteinuria was 1.68 (95% confidence interval 1.31 to 2.14) g/day during ACE inhibition plus a regular sodium diet. Addition of angiotensin receptor blockade to ACE inhibition reduced proteinuria to 1.44 (1.07 to 1.93) g/day (P=0.003), addition of a low sodium diet reduced it to 0.85 (0.66 to 1.10) g/day (P<0.001), and addition of angiotensin receptor blockade plus a low sodium diet reduced it to 0.67 (0.50 to 0.91) g/day (P<0.001). The reduction of proteinuria by the addition of a low sodium diet to ACE inhibition (51%, 95% confidence interval 43% to 58%) was significantly larger (P<0.001) than the reduction of proteinuria by the addition of angiotensin receptor blockade to ACE inhibition (21%, (8% to 32%) and was comparable (P=0.009, not significant after Bonferroni correction) to the reduction of proteinuria by the addition of both angiotensin receptor blockade and a low sodium diet to ACE inhibition (62%, 53% to 70%). Mean systolic blood pressure was 134 (3) mm Hg during ACE inhibition plus a regular sodium diet. Mean systolic blood pressure was not significantly altered by the addition of angiotensin receptor blockade (131 (3) mm Hg; P=0.12) but was reduced by the addition of a low sodium diet (123 (2) mm Hg; P<0.001) and angiotensin receptor blockade plus a low sodium diet (121 (3) mm Hg; P<0.001) to ACE inhibition. The reduction of systolic blood pressure by the addition of a low sodium diet (7% (SE 1%)) was significantly larger (P=0.003) than the reduction of systolic blood pressure by the addition of angiotensin receptor blockade (2% (1)) and was similar (P=0.14) to the reduction of systolic blood pressure by the addition of both angiotensin receptor blockade and low sodium diet (9% (1)), to ACE inhibition. CONCLUSIONS Dietary sodium restriction to a level recommended in guidelines was more effective than dual blockade for reduction of proteinuria and blood pressure in non-diabetic nephropathy. The findings support the combined endeavours of patients and health professionals to reduce sodium intake. Trial registration Netherlands Trial Register NTR675.
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The PREMIER intervention helps participants follow the Dietary Approaches to Stop Hypertension dietary pattern and the current Dietary Reference Intakes recommendations.
Lin, PH, Appel, LJ, Funk, K, Craddick, S, Chen, C, Elmer, P, McBurnie, MA, Champagne, C
Journal of the American Dietetic Association. 2007;(9):1541-51
Abstract
OBJECTIVE To examine the influence of the PREMIER study lifestyle interventions on dietary intakes and adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and the Dietary Reference Intakes (DRI). DESIGN An 18-month multicenter, randomized controlled trial comparing two multicomponent lifestyle intervention programs to an advice only control group. SUBJECTS/SETTING A total of 810 participants were recruited from local communities and randomized into the study. Individuals were eligible if they were aged 25 years or older, had body mass index between 18.5 and 45.0, not taking antihypertensive medication, and had prehypertension or stage 1 hypertension (systolic blood pressure 120 to 159 mm Hg and diastolic blood pressure 80 to 95 mm Hg). INTERVENTION The two active intervention programs were a behavioral lifestyle intervention that implements established recommendations, and an established intervention plus the DASH dietary pattern. Both interventions consisted of intensive group and individual counseling sessions. The control group received a brief advice session after randomization and again after 6 months of data collection. Dietary intakes were collected by two random 24-hour recalls at baseline, 6 months, and 18 months. MAIN OUTCOME MEASURES The primary outcome of the PREMIER study was change in systolic blood pressure at 6 months. The main outcomes examined here include dietary variables collected by 24-hour recall at each time point. STATISTICAL ANALYSES Nutrient intakes were calculated and compared among the time points and the three intervention groups using mixed models with repeated measures at 6 and 18 months. Proportion of participants who met or achieved the original DASH nutrient intake levels and the DRIs were calculated and compared among the three intervention groups. P<0.01 was considered statistically significant. RESULTS Participants in both the established intervention and established intervention plus DASH dietary pattern groups substantially reduced energy, total fat, saturated fat, and sodium intake and these reductions persisted throughout the study. Established intervention plus DASH dietary pattern group participants increased intakes of fruits, vegetables, dairy, and many vitamins and minerals; these increases were significantly greater than that of the control and established intervention groups. A majority of established intervention plus DASH dietary pattern group participants achieved at least two thirds of the DRI recommendations for most nutrients at 6 months, despite their reduction in total energy intake. Some but relatively small recidivism occurred at 18 months. CONCLUSIONS Both the established intervention and established intervention plus DASH dietary pattern group intervention were effective in helping participants follow established recommendations to control blood pressure. The advice-only control group also made some behavior changes, mainly decreasing energy and sodium intake. Only the established intervention plus DASH dietary pattern group significantly increased intakes of DASH-specific food groups, including fruits, vegetables, and dairy products, and nutrients, including protein, fiber, calcium, potassium, and magnesium. Most of the increases did not reach the levels consumed in the original DASH feeding studies. Whereas the established intervention plus DASH dietary pattern group intervention provides a useful platform to achieve the DASH dietary pattern and current DRI recommendations, intervention enhancements, including a greater emphasis on nutrient-dense foods, would likely improve this intervention.