Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China (DECIDE-Salt)
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ClinicalTrials.gov Identifier: NCT03290716 |
Recruitment Status :
Completed
First Posted : September 25, 2017
Last Update Posted : June 11, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | September 5, 2017 | ||||
First Posted Date ICMJE | September 25, 2017 | ||||
Last Update Posted Date | June 11, 2021 | ||||
Actual Study Start Date ICMJE | September 25, 2017 | ||||
Actual Primary Completion Date | October 24, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The change in systolic blood pressure from baseline to follow-up [ Time Frame: baseline、6 month、12 month、18 month and 24-month follow-up ] mmHg
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Original Primary Outcome Measures ICMJE |
The change in systolic blood pressure [ Time Frame: baseline and 24-month follow-up ] mmHg
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China | ||||
Official Title ICMJE | Diet, Exercise and Cardiovascular Health - Effect of Salt Substitute and Stepwise Salt Supply Control in Reducing Blood Pressure in the Elderly in Nursing Homes in China: a Factorial Cluster-randomized Controlled Trial | ||||
Brief Summary | The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 960 old people from 48 nursing homes in northern China. The 48 nursing homes will be randomised into the following 4 groups.
The intervention will last over 2 years. The randomization will be conducted centrally after the baseline survey completed. Primary outcome will be the change in systolic blood pressure. The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium, potassium and microalbumin, and incidence of hyperkalemia, hypokalemia, hyponatremia, cardiovascular events, and all causes death, and incremental cost-effectiveness ratio. |
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Detailed Description | The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is a study in the DECIDE project, which includes five studies. The others are DECIDE - Diet, DECIDE - Exercise, DECIDE - Obesity in Children, and DECIDE - Smart Living. The DECIDE - Salt in Elderly study is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and kitchen-based stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. Specifically, the study aims include:
The corresponding null hypotheses that will be tested are:
The study will recruit over 960 old people from 48 nursing homes in northern China, where the mean salt intake is generally higher than 12 g/day. A 2x2 factorial cluster-randomized trial will be used to test two independent salt reduction strategies: 1) using salt substitute to replace the regular salt in the kitchen of nursing homes; and 2) training the nursing manager to control/reduce, step by step, the amount of salt supplied to the kitchen of nursing homes. The 48 nursing homes will be randomized to the following 4 groups.
A brief health education on salt and health will be applied to all four groups. The salt substitute (NaCl 62.5% and KCl 25%) will be centrally provided. And the Train-the-trainers model will be used to train the nursing home managers how to implement the SSSC. The intervention will last over 2 years. The baseline examination including three blood pressure measurements and one 24-hr urine collection will be conducted for all participants. Fasting blood samples will be drawn for measurement of serum potassium and detect hyperkalemia, hypokalemia, hyponatremia and renal dysfunction. The randomization will be conducted centrally by the study coordinating center at Peking University Clinical Research Institute, after the baseline survey completed. All participants will be followed up for blood pressure measurements at 6, 12, 18 and 24 months, for serum potassium at 12 and 24 months, and for 24-hr urine collection at 24 months. Study outcomes: Primary outcome: The change in systolic blood pressure from baseline to follow-up. Secondary outcomes: The incidence of hyponatremia, hyperkalemia, hypokalemia and renal dysfunction from the baseline to 24 months. The change in 24-hr urinary sodium, potassium and microalbumin from the baseline to 24 months. The change in diastolic blood pressure from baseline to follow-up. The incremental cost-effectiveness ratio (ICER). The incidence of cardiovascular events and all causes death during follow up. Power analysis: On the assumptions of a 20% dropout rate, an intraclass correlation of 0.02, the number of clusters of 48 and at least 20 elderly people in each nursing home, and an α value of 0.05, the study to detect a mean 3.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg) between the intervention groups would have a power of 0.81. To detect a 4.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg), the power of the same sample size would be 0.96. Statistical analysis: Linear models adjusted for clustering based on participants with available measures were used to assess continuous outcomes. Frailty survival models that account for clustering based upon all randomised participants were used for analysis of the effects on cardiovascular and mortality outcomes. Generalized linear mixed model were used for analysis of effects on hyperkalemia, hypokalemia, hyponatremia and renal dysfunction.. Ethical considerations: The study will be submitted to and approved by the Peking University IRB, which has the full accreditation from AAHRRP. The study salt substitute is the product available on Chinese market and has been approved manufactured according to the product standards issued by the ministry of health. The SSSC approach will take every step for 3 months and the biggest step of salt reduction will be just 10% of the original amount of use. And the study will ensure an interview will be conducted to collect the feedback before every next step will take place. The SSSC intervention will stop at any time that elderly people feel unlike the foods. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Blood Pressure | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Jin A, Zhao M, Sun Y, Feng X, Zhang R, Qiao Q, Wang H, Yuan J, Wang Y, Cheng L, Zhang H, Li HJ, Wu Y. Normal range of serum potassium, prevalence of dyskalaemia and associated factors in Chinese older adults: a cross-sectional study. BMJ Open. 2020 Oct 30;10(10):e039472. doi: 10.1136/bmjopen-2020-039472. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1612 | ||||
Original Estimated Enrollment ICMJE |
1080 | ||||
Actual Study Completion Date ICMJE | May 11, 2021 | ||||
Actual Primary Completion Date | October 24, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Eligibility of nursing homes:
Eligibility of individual elderly: Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 55 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03290716 | ||||
Other Study ID Numbers ICMJE | 2016YFC130020302 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Yangfeng Wu, Peking University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Peking University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Peking University | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |