Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults.

BACKGROUND: Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. OBJECTIVES: This study sought to assess the effects of a salt substitute (62.5% NaCl, 25% KCl, and 12.5% flavorings) on incidence of hypertension and hypotension among older adults with normal blood pressure. METHOD: A post hoc analysis was conducted among older adults with normal blood pressure participating in DECIDE-Salt, a large, multicenter, cluster-randomized trial in 48 elderly care facilities for 2 years. We used the frailty survival model to compare risk of incident hypertension and the generalized linear mixed model to compare risk of hypotension episodes. RESULTS: Compared with usual salt group (n = 298), the salt substitute group (n = 313) had a lower hypertension incidence (11.7 vs 24.3 per 100 person-years; adjusted HR: 0.60; 95% CI: 0.39 to 0.92; P = 0.02) but did not increase incidence of hypotension episodes (9.0 vs 9.7 per 100 person-years; P = 0.76). Mean systolic/diastolic blood pressure did not increase from the baseline to the end of intervention in the salt substitute group (mean changes: -0.3 ± 11.9/0.2 ± 7.1 mm Hg) but increased in the usual salt group (7.0 ± 14.3/2.1 ± 7.5 mm Hg), resulting in a net reduction of -8.0 mm Hg (95% CI: -12.4 to -3.7 mm Hg) in systolic and -2.0 mm Hg (95% CI: -4.1 to 0.1 mm Hg) in diastolic blood pressure between intervention groups. CONCLUSIONS: In Chinese older adults with normal blood pressure, replacing usual salt with a salt substitute may reduce the incidence of hypertension without increasing hypotension episodes. This suggests a desirable strategy for population-wide prevention and control of hypertension and cardiovascular disease, deserving further consideration in future studies. (Diet Exercise and Cardiovascular Health [DECIDE]-Salt Reduction Strategies for the Elderly in Nursing Homes in China [DECIDE-Salt]; NCT03290716).

Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial.

Importance: Salt substitution has been reported to be a cost-saving sodium reduction strategy that has not yet been replicated in different contexts. Objective: To estimate the cost-effectiveness of sodium reduction strategies within the DECIDE-Salt trial. Design, Setting, and Participants: The DECIDE-Salt trial cluster randomized in a 1:1:1:1 ratio 48 eldercare facilities in China into 4 groups for evaluation of 2 sodium reduction strategies for 2 years: 1 with both strategies, 2 with either strategy, and 1 with neither strategy. The trial was conducted from September 25, 2017, through October 24, 2020. Interventions: The 2 intervention strategies were replacing regular salt with salt substitute and progressively restricting salt supply to kitchens. Main Outcomes and Measures: The main outcomes included per-participant costs of intervention implementation and medical treatments for hypertension and major adverse cardiovascular events (MACEs) against mean reductions in systolic blood pressure, hypertension prevalence, MACE incidence, and mortality. The incremental cost-utility ratio was then assessed as the additional mean cost per quality-adjusted life-year gained. Analyses were conducted separately for each strategy, comparing groups assigned and not assigned the test strategy. Disease outcomes followed the intention-to-treat principle and adopted different models as appropriate. One-way and probabilistic sensitivity analyses were conducted to explore uncertainty, and data analyses were performed between August 13, 2022, and April 5, 2023. Results: A total of 1612 participants (1230 males [76.3%]) with a mean (SD) age of 71.0 (9.5) years were enrolled. Replacing regular salt with salt substitute reduced mean systolic blood pressure by 7.14 (95% CI, 3.79-10.48) mm Hg, hypertension prevalence by 5.09 (95% CI, 0.37-9.80) percentage points, and cumulative MACEs by 2.27 (95% CI, 0.09-4.45) percentage points. At the end of the 2-year intervention, the mean cost was $25.95 less for the salt substitute group than the regular salt group due to substantial savings in health care costs for MACEs (mean [SD], $72.88 [$9.11] vs $111.18 [$13.90], respectively). Sensitivity analysis showed robust cost savings. By contrast, the salt restriction strategy did not show significant results. If the salt substitution strategy were rolled out to all eldercare facilities in China, 48 101 MACEs and 107 857 hypertension cases were estimated to be averted and $54 982 278 saved in the first 2 years. Conclusions and Relevance: The findings of this cluster randomized clinical trial indicate that salt substitution may be a cost-saving strategy for hypertension control and cardiovascular disease prevention for residents of eldercare facilities in China. The substantial health benefit savings in preventing MACEs and moderate operating costs offer strong evidence to support the Chinese government and other countries in planning or implementing sodium intake reduction and salt substitute campaigns. Trial Registration: ClinicalTrials.gov Identifier: NCT03290716.

Experience with 2 years' intervention to progressively reduce salt supply to kitchens in elderly care facilities-challenges and further research: post hoc analysis of the DECIDE-Salt randomized clinical trial.

BACKGROUND: Progressive reduction of sodium intake is an attractive approach for addressing excessive salt intake, but evidence for this strategy in real practice is limited. We aimed to determine the feasibility, effectiveness, and safety of a progressive sodium intake reduction intervention in real-world setting. METHODS: We randomized 48 residential elderly care facilities in China, with 1612 participants aged 55 years and older, to either progressive reduction (PR, 24 facilities) or no reduction (NR, 24 facilities) of the supply of study salt to the kitchens of these facilities for 2 years. The primary efficacy outcome was systolic blood pressure (SBP) at any scheduled follow-up visit. Secondary efficacy outcomes included diastolic blood pressure (DBP) at any scheduled follow-up visit, and major adverse cardiovascular events (comprising non-fatal stroke, non-fatal myocardial infarction, hospitalized non-fatal heart failure, or vascular death) and total mortality. The perception of food saltiness, the addition of out-of-study salt in meals, and 24-h urinary sodium excretion were used as process indicators. RESULTS: Pre-specified analysis per randomization found no effect of the intervention on the 2-year overall mean systolic and diastolic blood pressure (SBP, DBP) and any other outcomes. However, post hoc analysis showed that the intervention effect on blood pressure varied over multiple follow-up visits (p for interaction < 0.046) and presented favorable differences at the 24-month visit (SBP = - 3.0 mmHg, 95%CI = - 5.6, - 0.5; p = 0.020; DBP = - 2.0 mmHg, 95%CI - 3.4, - 0.63; p = 0.004). The effect on 24-h sodium was non-significant (- 8.4 mmol, 95%CI = - 21.8 to 4.9, p = 0.216), though fewer participants with NR than with PR reported food tasting bland (odds ratio 0.46; 95%CI 0.29 to 0.73; p = 0.001). Reporting of bland food taste and other process measures indicated that intervention delivery and adherence were not fully achieved as designed. CONCLUSIONS: The experience of this real-world study demonstrated that achieving acceptability and sustainability of the progressive sodium intake reduction strategy among older adults was challenging, but it has shown potential for effectiveness in these and potentially other residential settings if the lessons of DECIDE-Salt are applied in further studies. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03290716).

Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey.

OBJECTIVES: Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions. DESIGN: A cross-sectional study conducted from September 2017 to March 2018. SETTING: 48 residential elderly care facilities in northern China. PARTICIPANTS: Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia. EXPOSURE: Potassium intake is measured by 24-hour urinary potassium. OUTCOMES: Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect. RESULTS: Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted ß=0.0040/L; p=0.017) and high (adjusted ß=0.0078/L; p=0.003) but not low (adjusted ß=0.0018/L; p=0.311) risk of hyperkalaemia. CONCLUSIONS: A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns. TRIAL REGISTRATION NUMBER: NCT03290716; Post-results.

Association of Peer Network with Childhood Obesity in DECIDE-Children Program.

Some studies have found associations between the peer network and childhood obesity. The present study aimed to analyze the association of the peer network with obesity-related cognition, behaviors and adiposity indicators, and explore whether peer network influences the effect of a childhood-obesity intervention. Based on DECIDE-Children, 1392 children's friendship nominations within the class were collected and peer network indicators including the network size, network density, and in- and out-degree centrality were calculated. The linear mixed model was used to analyze the association between peer network indicators and children's cognition, behaviors and adiposity indicators (body mass index (BMI), BMI z score, the prevalence of overweight and obesity). Children with a higher in-degree centrality had 34.4% (95%CI: 17.4% to 48.1%) lower risk of overweight or obesity. The baseline degree centrality was inversely associated with the BMI and BMI z score at the end of the trial. For each unit increase in in-degree centrality at baseline, the BMI at the end of the trial decreased by 0.047 (95%CI: 0.015 to 0.080), and the BMI z score decreased by 0.015 (95%CI: 0.003 to 0.028). Children's popularity reflected by centrality in their peer network was associated with cognition, behaviors, and adiposity indicators. Future childhood-obesity intervention research could pay more attention to socially inactive children.

Effect of a Multifaceted Intervention on Children's Body Image and the Mediating Role of Body Image in Changes in Adiposity Indicators.

Besides genetic factors and energy-related behaviors, psycho-cultural factors are also important in obesity etiology. Previous studies have suggested that improving body image might be an effective method for managing body weight. Thus, this study aimed to evaluate the effects of a multifaceted intervention on the body image of children and explore whether body image played a mediating role in changes in adiposity indicators. This study was embedded in a cluster randomized controlled trial, involving 1287 children from 24 primary schools in three cities in China (Beijing, Changzhi and Urumqi). The 9-month multifaceted intervention on childhood obesity included five components (three targeted children and two targeted environments), and randomization was performed by an independent person who was blinded to the schools. Two indicators (body size perception and body size expectation) were chosen to characterize body image and were measured by Ma figural stimuli at baseline and the end of the trial. Changes in body image indicators were classified as conducive to weight loss or not. Other anthropometric measures and self-reported behaviors were also collected at both time points. Generalized linear mixed models were used in the analyses. Compared to the controls (n = 648), the proportion of body size perception conducive to weight loss increased in the intervention group (n = 639), with an odds ratio of 2.42 (95%CI: 1.70~3.45, p < 0.001). The proportion of body size expectation conducive to weight loss also increased more in the intervention group than in the controls (OR = 1.74, 95%CI: 1.14~2.66, p = 0.010). In children whose baseline nutritional status was "normal weight with higher BMI" or "overweight/obese", the improvements in body size perception and body size expectation partly mediated the association between the intervention and changes in BMI, BMI Z score, waist circumference and body fat percentage (p < 0.05). This multifaceted study effectively improved the body image of children, which, in turn, led to beneficial changes in adiposity indicators. For the first time, body size perception and body size expectation have been confirmed to be important factors associated with the beneficial effect of a childhood obesity intervention, suggesting that body image components should be generalized in the future.

Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial.

There is a paucity of high-quality evidence on the effectiveness and safety of salt reduction strategies, particularly for older people, who have the most to benefit but are at higher risk of adverse effects. Here, we conducted a clinical trial in which 48 residential elderly care facilities in China (1,612 participants including 1,230 men and 382 women, 55 years or older) were cluster-randomized using a 2 × 2 factorial design to provision of salt substitute (62.5% NaCl and 25% KCl) versus usual salt and to a progressively restricted versus usual supply of salt or salt substitute for 2 years. Salt substitute compared with usual salt lowered systolic blood pressure (-7.1 mmHg, 95% confidence interval (CI) -10.5 to -3.8), meeting the primary outcome of the trial, whereas restricted supply compared with usual supply of salt or salt substitute had no effect on systolic blood pressure. Salt substitute also lowered diastolic blood pressure (-1.9 mmHg, 95% CI -3.6 to -0.2) and resulted in fewer cardiovascular events (hazard ratio (HR) 0.60, 95% CI 0.38-0.96), but had no effect on total mortality (HR 0.84, 95% CI 0.63-1.13). From a safety standpoint, salt substitute increased mean serum potassium and led to more frequent biochemical hyperkalemia, but was not associated with adverse clinical outcomes. In contrast, salt restriction had no effect on any study outcome. The results of this trial indicate that use of salt substitute, but not efforts to restrict salt supply, may achieve blood pressure lowering and deliver health benefits to residents of elderly care facilities in China. Clinicaltrials.gov registration: NCT03290716.

Comparison of the performance of HPV DNA chip test and HPV PCR test in cervical cancer screening in rural China.

Background: This study aimed to evaluate the performance of two different principles of HPV testing in primary cervical cancer screening and ASC-US triage in rural areas. Methods: 3,328 and 3,913 women were enrolled in Shanxi, China in 2017 and 2018, respectively, and screened using liquid-based cytology and different HPV tests with a 4-year follow-up. Different screening methods commonly used in clinical practice were evaluated. Results: In the HPV PCR test cohort, the prevalence of HPV infection was 14.90%. A total of 38 cases of CIN2+ were identified at baseline, 2 of which were in the HPV-negative cohort and the rest in the HPV-positive cohort (2 = 186.85, p < 0.001). Fifty-three cases of CIN2+ were accumulated over 4 years. The HPV infection rate in the HPV DNA chip test cohort was 21.10%. A total of 26 CIN2+ cases were identified at baseline, all in the HPV-positive population (2 = 92.96, p < 0.001). 54 CIN2+ cases were cumulative over 4 years. At 4-year follow-up, HPV-negative results were significantly more protective against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) than normal cytologic results at baseline. HPV screening was more sensitive and specific than cytologic screening (using ASC-US as the threshold) and performed better on the HPV DNA microarray test. In addition, compared with HPV 16/18 testing, sensitivity increases and specificity decreases when using HPV testing for cytologic ASC-US triage, regardless of which HPV test is used. Conclusion: In the rural areas where we implemented the study, HPV tests performed well for screening than LBC and HPV DNA chip testing performed better than HPV PCR testing in the screening cohort. Optimal screening was achieved technically when used in combination with LBC for ASC-US population triage, without thinking the feasibility for resource availability.

A Method for Estimating 24 h Urinary Sodium and Potassium Excretion by Spot Urine Specimen in Stroke Patients.

Spot urine specimens have been used to estimate 24 h urinary sodium (Na) excretion (24UNaV) and potassium (K) excretion (24UKV). However, the validity is limited for 24UNaV and unknown for 24UKV in stroke patients, using the existing formulas. Herein, we developed and validated a new formula for 24UNaV and 24UKV by spot urine specimens in stroke patients. Spot and 24 h urine samples were collected from 970 stroke patients. The models of 24UNaV and 24UKV were developed using stepwise multivariate linear regression in 689 patients. The performance of different formulas was internally validated in 281 patients at the population and individual levels. The obtained new formulas were: (1) estimated 24UNaV (mmol/day): -0.191 × Age + 4.349 × BMI + 0.229 × SpotNa + 1.744 × SpotNa/Spot creatinine (Cr) + 41.492 (for male); -1.030 × Age + 2.011 × BMI + 0.143 × SpotNa + 1.035 × SpotNa/SpotCr + 147.159 (for female); and (2) estimated 24UKV (mmol/day): -0.052 × Age + 0.410 × BMI + 0.031 × SpotK + 33.280 × Ln (spotK/spot Cr) - 5.789 × Ln (spotNa/spot Cr) - 1.035 (for male); -0.235 × Age + 0.530 × BMI + 0.040 × SpotK + 30.990 × Ln (spot K/spot Cr) - 7.837 × Ln (spotNa/spotCr) + 4.318 (for female). The new formula obtained the lowest mean bias (5.17 mmol/day for 24UNaV and 0.85 mmol/day for 24UKV) and highest proportion at the cutoff under the ±30% level for the estimation of 24UNaV (59.43%) and 24UKV (70.11%). The new formula provides a meaningful exploration to estimate 24UNaV and 24UKV in stroke patients by using spot urine specimens.

Comparison of primary cytology, primary HPV testing and co-testing as cervical cancer screening for Chinese women: a population-based screening cohort.

OBJECTIVES: We compared clinical performance of three strategies of primary human papillomavirus (HPV) testing, primary cytology and co-testing for cervical cancer screening. DESIGN: A population-based prospective cohort study of clinical performance of screening strategy. SETTING: Patients recruited from community in Changzhi County, Shanxi Province, China. PATIENT: 3209 women aged 30-64 years without gynaecological issues. PRIMARY AND SECONDARY OUTCOME MEASURES: The performance of different screening strategies for detecting cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). RESULTS: A total of 53 CIN2+ and 31 CIN3+ cases are detected. For CIN2+, sensitivity of primary HPV (95.9%) and co-testing (98.0%) are not statistically different, but significantly higher than primary cytology (48.0%). Specificity (86.8%), colposcopy referral rate (7.8%) and number of colposcopies required to detect one case (9.8) for primary HPV are better than co-testing (79.8%, 11.9%, 14.3%, respectively). For CIN3+, primary HPV, co-testing have 100% of sensitivity and specificity, which is significantly higher than primary cytology (56.7% and 90.2%). Number of colposcopies required to detect one case for primary HPV (15.9) is better than co-testing (23.8). CONCLUSIONS: Compared with co-testing, HPV primary screening had comparable sensitivity and higher specificity for CIN2+ detection, and both of them showed better performance than cytology primary screening in cervical cancer screening.

Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population.

As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major issue involves validating more HPV tests. In recent years, some HPV tests are used for clinical performance verification in China. The purpose of this study was to explore whether the BD Onclarity (Becton, Dickinson and Company)HPV assay differs from the Roche cobas (Roche Molecular Systems)HPV assay, as determined using 944 cervical samples, including 588 with sequencing results. In the nucleic acid assay accuracy verification, the assays showed excellent concordance for detection of HPV16 (κ = 0.93, 95% confidence interval [CI]: 0.89-0.97) and HPV18 (κ = 0.90, 95% CI: 0.83-0.97), and very good concordance for the 12 other high-risk types (HPV31/33/35/39/45/51/52/56/58/59/66/68, κ = 0.79, 95% CI: 0.75-0.83). The overall agreement for HPV DNA detection between Onclarity and cobas was very good (κ = 0.7755). No difference for ≥CIN2 sensitivity was observed between Onclarity and cobas (both 96.5%), whereas the ≥CIN2 specificity for detection of Onclarity (16.6%, 95% CI: 13.7-19.9) was higher than that of cobas (11.5%, 95% CI: 9.1-14.5). Onclarity exhibited comparable screening performance and triage efficiency compared to cobas in the detection of cervical disease in Chinese women.

The Effect of a Multifaceted Intervention on Dietary Quality in Schoolchildren and the Mediating Effect of Dietary Quality between Intervention and Changes in Adiposity Indicators: A Cluster Randomized Controlled Trial.

Some studies have found associations between dietary quality and obesity and their concurrent changes were observed in a few interventions. The present study aimed to assess the effect of a multifaceted intervention for childhood obesity on dietary quality and examine the mediating effect of dietary quality between the intervention and changes in adiposity indicators. Based on the social ecological model, the cluster randomized controlled trial included five components (three targeted children and two targeted their environment). In total, 1176 children from three cities in China participated in a baseline (2018) and end-of-trial (2019) examination, including 605 children in the intervention group and 571 in the control group. Self-reported behavior and anthropometric measures were collected at both time points. The Diet Balance Index Revision (DBI-07) was calculated to assess dietary quality. Generalized linear mixed models were used to estimate the intervention effect on dietary quality and its mediating effects were examined. Compared to the controls, the proportion of sugar-sweetened beverage (SSB) intake (OR = 0.27, p < 0.001, corrected p < 0.001) decreased in the intervention group. Higher bound scores (HBS) of the DBI-07 indicating over-intake decreased in the intervention group compared to the controls (mean difference = −1.52, p = 0.005, corrected p = 0.015). Changes in the HBS partially mediated the associations between the intervention and changes in body mass index, waist circumference, and body fat percentage. Future intervention should promote knowledge, attitudes, and behaviors related to dietary quality.

Cost-Effectiveness of a Household Salt Substitution Intervention: Findings From 20 995 Participants of the Salt Substitute and Stroke Study.

BACKGROUND: SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among individuals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention. METHODS: A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models. RESULTS: Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77-0.96]; P=0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a >99.9% probability of being cost-effective. CONCLUSIONS: Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants.

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

Importance: A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited. Objective: To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children. Design, Setting, and Participants: A cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol. Twenty-four schools were randomly allocated (1:1) to the intervention or the control group, with 1392 eligible children aged 8 to 10 years participating. Data from the intent-to-treat population were analyzed from October 1 to December 31, 2019. Interventions: A multifaceted intervention targeted both children (promoting healthy diet and physical activity) and their environment (engaging schools and families to support children's behavioral changes). The intervention was novel in its strengthening of family involvement with the assistance of a smartphone app. The control schools engaged in their usual practices. Main Outcomes and Measures: The primary outcome was the change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters) from baseline to the end of the trial. Secondary outcomes included changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness. Generalized linear mixed models were used in the analyses. Results: Among the 1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses. From baseline to the end of the trial, the mean BMI decreased in the intervention group, whereas it increased in the control group; the mean between-group difference in BMI change was -0.46 (95% CI, -0.67 to -0.25; P < .001), which showed no evidence of difference across different regions, sexes, maternal education levels, and primary caregivers (parents vs nonparents). The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group. The intervention also improved other adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure. No adverse events were observed during the intervention. Conclusions and Relevance: The multifaceted intervention effectively reduced the mean BMI and obesity prevalence in primary school children across socioeconomically distinct regions in China, suggesting its potential for national scaling. Trial Registration: ClinicalTrials.gov Identifier: NCT03665857.

Factors Associated With the Use of a Salt Substitute in Rural China.

Importance: Lowering sodium intake reduces blood pressure and may reduce the risk of cardiovascular diseases. The use of reduced-sodium salt (a salt substitute) may achieve sodium reduction, but its effectiveness may be associated with the context of its use. Objective: To identify factors associated with the use of salt substitutes in rural populations in China within the Salt Substitute and Stroke Study, a large-scale cluster randomized trial. Design, Setting, and Participants: This sequential mixed-methods qualitative evaluation, conducted from July 2 to August 28, 2018, in rural communities across 3 provinces in China, included a quantitative survey, collection of 24-hour urine samples, and face-to-face interviews. A random subsample of trial participants, selected from the 3 provinces, completed the quantitative survey (n = 1170) and provided urine samples (n = 1025). Interview respondents were purposively selected from the intervention group based on their different ranges of urinary sodium excretion levels. Statistical analysis was performed from September 18, 2018, to February 22, 2019. Exposures: The intervention group of the Salt Substitute and Stroke Study was provided with the free salt substitute while the control group continued to use regular salt. Main Outcomes and Measures: Knowledge, attitudes, and behaviors regarding the use of the salt substitute were measured using quantitative surveys, and urinary sodium levels were measured using 24-hour urine samples. Contextual factors were explored through semistructured interviews and integrated findings from surveys and interviews. Results: A total of 1170 individuals participated in the quantitative survey. Among the 1025 participants with successful urine samples, the mean (SD) age was 67.4 (7.5) years, and 502 (49.0%) were female. The estimated salt intake of participants who believed that high salt intake was good for health was higher; however, it was not significantly different (0.84 g/d [95% CI, -0.04 to 1.72 g/d]) from those who believed that high salt intake was bad for health. Thirty individuals participated in the qualitative interviews (18 women [60.0%]; mean [SD] age, 70.3 [6.0] years). Quantitative and qualitative data indicated high acceptability of and adherence to the salt substitute. Contextual factors negatively associated with the use of the salt substitute included a lack of knowledge about the benefits associated with salt reduction and consumption of high-sodium pickled foods. In addition, reduced antihypertensive medication was reported by a few participants using the salt substitute. Conclusions and Relevance: This study suggests that lack of comprehensive understanding of sodium reduction and salt substitutes and habitual consumption of high-sodium foods (such as pickled foods) were the main barriers to the use of salt substitutes to reduce sodium intake. These factors should be considered in future population-based, sodium-reduction interventions.

Effect of Salt Substitution on Cardiovascular Events and Death.

BACKGROUND: Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain. METHODS: We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia. RESULTS: A total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76). CONCLUSIONS: Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt. (Funded by the National Health and Medical Research Council of Australia; SSaSS ClinicalTrials.gov number, NCT02092090.).

Randomised trial on effect of involving media reporters in salt reduction programme to increase media reports and the public's knowledge, belief and behaviors on salt and health: Changzhi reporters trial.

OBJECTIVE: To assess the effects of a novel mass media intervention in increasing media reports on salt and health by involving media reporters in a scientifically well designed salt reduction trial. METHODS: We recruited and trained 66 media reporters in Changzhi, Shanxi province, China to conduct a randomized controlled trial on blood pressure lowering effect of salt substitute in Dec, 2012 and Jan 2013 among their own relatives or friends (253 from 129 families in the salt substitute arm and 263 from 133 families in the control arm for two months). We shared trial results and other information on salt and health with the reporters within a month after the trial. We monitored all local newspapers for the number of relevant articles in 3 months before, 3 months during and 3 months after the intervention and at the 6th, 12th, 18th, 24th and 48th months after the intervention. Additionally, we conducted two independent surveys on knowledge, belief and behaviours of salt and health among local citizens before and after the intervention. RESULTS: As expected, systolic blood pressure was reduced significantly more in the salt substitute than the control group (-4.7±11.0 mmHg vs -2.6±10.3 mmHg, p<0.001) in the randomized trial. The monthly mean number of relevant articles increased from 0.7 before to 1.7 during (p = 0.263), and further to 6.0 after the intervention (p<0.001), and varied from 2 (p = 0.170) to 4 (p = 0.008) from the 6th to 48th month; the awareness of knowledge on salt and health among local citizens improved significantly after the intervention. CONCLUSIONS: Media reporters' participation in a well-designed salt reduction trial significantly increased the number of relevant media reports, and the effect was sustained for a prolonged period. Future mass media public health education programs should consider this innovative strategy for better and sustained impacts.

Protocol for the economic evaluation of the China Salt Substitute and Stroke Study (SSaSS).

INTRODUCTION: Cardiovascular diseases (CVDs) are the leading causes of death and disability worldwide. Reducing dietary salt consumption is a potentially cost-effective way to reduce blood pressure and the burden of CVD. To date, economic evidence has focused on sodium reduction in food industry or processed food with blood pressure as the primary outcome. This study protocol describes the planned within-trial economic evaluation of a low-sodium salt substitute intervention designed to reduce the risk of stroke in China. METHODS AND ANALYSES: The economic evaluation will be conducted alongside the Salt Substitute and Stroke Study: a 5-year large scale, cluster randomised controlled trial. The outcomes of interest are quality of life measured using the EuroQol-5-Dimensions and major adverse cardiovascular events. Costs will be estimated from a healthcare system perspective and will be sought from the routinely collected data available within the New Rural Cooperative Medical Scheme. Cost-effectiveness and cost-utility analyses will be conducted, resulting in the incremental cost-effectiveness ratio expressed as cost per cardiovascular event averted and cost per quality-adjusted life year gained, respectively. ETHICS AND DISSEMINATION: The trial received ethics approval from the University of Sydney Ethics Committee (2013/888) and Peking University Institutional Review Board (IRB00001052-13069). Informed consent was obtained from each study participant. Findings of the economic evaluation will be published in a peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02092090).

Compliance and associated factors of smartphone application usage in child dietary and exercise intervention / 中国学校卫生

Objective@#To study the compliance and associated factors of smartphone application (APP) usage in childhood dietary and exercise intervention.@*Methods@#Based on one childhood intervention of diet and exercise in Beijing, Changzhi of Shanxi Province and Urumqi of Xinjiang Province, 694 children (and their primary caregivers) in the intervention group were investigated regarding usage of APP during the intervention. Compliance of APP usage was evaluated by the click times of APP, and Logistic regression models were used to analyze influencing factors of the compliance.@*Results@#The median (inter quartile range) click times of APP in the four modules (information dissemination, behavior monitoring, homework uploading and feedback) were 10 (5，21), 20 (14，26), 7(4，10), 26 (15，53), respectively. Multivariable logistic regression analysis found that compliance of APP usage was higher among subjects in Changzhi region ( OR =1.67，95% CI =1.12-2.48), whose primary caregiver was mother ( OR =1.55，95% CI =1.09-2.22), or whose mother did not work ( OR =0.47， 95% CI =0.31-0.74).@*Conclusion@#Compliance of APP usage was generally high in the childhood intervention of diet and exercise. Some factors are associated with compliance of APP usage. Findings of the study provide a scientific basis for better implementation of APP based childhood interventions of diet and exercise in the future.

Feasibility and validity of using death surveillance data and SmartVA for fact and cause of death in clinical trials in rural China: a substudy of the China salt substitute and stroke study (SSaSS).

BACKGROUND: In rural China, mortality surveillance data may be an alternative to primary data collection in clinical trials; SmartVA (verbal autopsy) is also a potential alternative for endpoint adjudication. The feasibility and validity of both need to be assessed. METHODS: We used mortality data from the first 24 months of the China Salt Substitute and Stroke Study (SSaSS) trial and assessed the agreement between (1) mortality surveillance data and face-to-face visits for fact of death; (2) mortality surveillance data and SSaSS adjudication for causes of death; (3) SmartVA and SSaSS adjudication for causes of death; (4) cause-specific mortality fraction of different methods. Face-to-face visits and SSaSS adjudication were taken as reference methods. The agreement was measured by sensitivity, specificity and positive predictive value (PPV) across different 10th Revision of International Statistical Classification of Diseases chapters. RESULTS: One thousand three hundred and sixty-five deaths were included. Mortality surveillance data had 82% sensitivity for fact of death and 81% sensitivity for causes of death, with substantial variances across different disease types and reasonable quality for circulatory death (91% sensitivity and 94% PPV). The sensitivity of SmartVA for causes of death was 61%, with reasonable quality for deaths of external causes of morbidity (90% sensitivity). The leading causes of death from different sources were the same with some variances in the fractions. CONCLUSION: Using mortality surveillance data for fact of death in clinical trials need to account for under-reporting. A face-to-face visit to all participants at the completion of trials may be warranted. Neither mortality surveillance data nor SmartVA provided valid data source for endpoint events.