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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 : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
Changzhi Medical College
Xian Jiaotong University
Hohhot Center for Disease Control and Prevention
Information provided by (Responsible Party):
Yangfeng Wu, Peking University

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 1080 old people from 36 nursing homes in northern China. The 36 nursing homes will be randomised into the following 4 groups.

  1. salt substitute (SS) and stepwise salt supply control (SSSC);
  2. SS only;
  3. SSSC only; and
  4. no SS and no SSSC (control).

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 and cardiovascular events, and incremental cost-effectiveness ratio.


Condition or disease Intervention/treatment Phase
Blood Pressure Other: SS Other: SSSC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SS+SSSC
Salt substitute plus stepwise salt supply control
Other: SS
Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
Other Name: Salt substitution

Other: SSSC
A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
Other Name: Stepwise salt supply control

Experimental: SS only
Salt substitute only
Other: SS
Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
Other Name: Salt substitution

Experimental: SSSC only
Stepwise salt supply control only
Other: SSSC
A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
Other Name: Stepwise salt supply control

No Intervention: control
No salt substitute and no stepwise salt supply control



Primary Outcome Measures :
  1. The change in systolic blood pressure [ Time Frame: baseline and 24-month follow-up ]
    mmHg


Secondary Outcome Measures :
  1. The incidence of hyperkalemia [ Time Frame: throughout 24 months of follow-up ]
    total incidence cases of hyperkalemia identified among all nursing home residents

  2. The change in 24-hour urinary sodium and potassium [ Time Frame: baseline and 24-month follow-up ]
    mmol/day

  3. The change in 24-hour urinary microalbumin [ Time Frame: baseline and 24-month follow-up ]
    mg/day

  4. The change in diastolic blood pressure [ Time Frame: baseline and 24-month follow-up ]
    mmHg

  5. The change in ICER [ Time Frame: baseline and 24-month follow-up ]
    Incremental cost-effectiveness ratio (ICER) was estimated based on the observed effectiveness in lowering SBP.

  6. Cardiovascular events [ Time Frame: throughout 24 months of follow-up ]
    all cardiovascular death and non-fatal myocardial infarction and stroke



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility of nursing homes:

  • To be eligible, the nursing home must has not participated in any salt-reduction or other intervention trials, has at least 30 residents and has agreed to participate in the study.

Eligibility of individual elderly:

Inclusion Criteria:

  • Living in the nursing home permanently or expectedly for the coming two years
  • Life expectancy over six months.
  • Provide written informed content.

Exclusion Criteria:

  • No.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290716


Contacts
Contact: Aoming Jin 0086-15201277670 jinaoming@126.com
Contact: Huijuan Li, PhD 0086-01082805564-612 pucri_lihj@bjmu.edu.cn

Locations
China, Shanxi
Mishan Nursing Home Recruiting
Jincheng, Shanxi, China
Contact: Xiangxian Feng    0086-035530250000    xfeng66@163.com   
Sponsors and Collaborators
Peking University
Changzhi Medical College
Xian Jiaotong University
Hohhot Center for Disease Control and Prevention
Investigators
Principal Investigator: Yangfeng Wu, PhD Peking University

Responsible Party: Yangfeng Wu, Prof of Epidemiology and Sciences in Clincial Research, Peking University
ClinicalTrials.gov Identifier: NCT03290716     History of Changes
Other Study ID Numbers: 2016YFC130020302
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No