Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China

NCT03290716 | Completed DMC

• 1 other identifier: 2016YFC130020302
• Study Type: interventional
• Target: 1,612
• Locations: 1 country
• Sites: 1

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.

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• The change in systolic blood pressure from baseline to follow-up

  mmHg

  baseline、6 month、12 month、18 month and 24-month follow-up

Secondary Outcomes (10)

• The incidence of hyperkalemia

  throughout 24 months of follow-up

• The incidence of hypokalemia

  throughout 24 months of follow-up

• The change in 24-hour urinary sodium and potassium

  baseline and 24-month follow-up

• The change in 24-hour urinary microalbumin

  baseline and 24-month follow-up

• The change in diastolic blood pressure from baseline to follow-up

  baseline、6 month、12 month、18 month and 24-month follow-up

Study Arms (4)

SS+SSSC

EXPERIMENTAL

Salt substitute plus stepwise salt supply control

Other: SS; Other: SSSC

SS only

EXPERIMENTAL

Salt substitute only

Other: SS

SSSC only

EXPERIMENTAL

Stepwise salt supply control only

Other: SSSC

control

NO INTERVENTION

No salt substitute and no stepwise salt supply control

Interventions

SS OTHER

Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.

Also known as: Salt substitution

SS only; SS+SSSC

SSSC OTHER

A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.

Also known as: Stepwise salt supply control

SS+SSSC; SSSC only

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in the nursing home permanently or expectedly for the coming two years
• Age less than 55 years.
• Life expectancy over six months.
• Provide written informed content.

You may not qualify if:

• Clinically confirmed hyperkalemia

Sponsors & Collaborators

• Peking University: lead
• Changzhi Medical College: collaborator
• Xi'an Jiaotong University: collaborator
• Hohhot Center for Disease Control and Prevention: collaborator
• Yangcheng Ophthalmology Hospital: collaborator

Study Sites (1)

Mishan Nursing Home

Jincheng, Shanxi, China

Location

Related Publications (6)

• Zhang X, Yuan Y, Li C, Feng X, Wang H, Qiao Q, Zhang R, Jin A, Li J, Li H, Wu Y. Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults. J Am Coll Cardiol. 2024 Feb 20;83(7):711-722. doi: 10.1016/j.jacc.2023.12.013.

  PMID: 38355240 DERIVED

• Lai X, Yuan Y, Wang H, Zhang R, Qiao Q, Feng X, Jin A, Li H, Li J, Si L, Gao P, Jan S, Fang H, Wu Y; DECIDE-Salt Research Group. Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2355564. doi: 10.1001/jamanetworkopen.2023.55564.

  PMID: 38345818 DERIVED

• Yuan Y, Jin A, Zhao MH, Wang H, Feng X, Qiao Q, Zhang R, Gao R, Wu Y. Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey. BMJ Open. 2023 Nov 24;13(11):e077249. doi: 10.1136/bmjopen-2023-077249.

  PMID: 38000815 DERIVED

• Yuan Y, Jin A, Duan P, Cao L, Wang H, Hu S, Li J, Feng X, Qiao Q, Zhang H, Zhang R, Li H, Gao P, Xie G, Yuan J, Cheng L, Wang S, Niu W, Elliott P, Gao R, Labarthe D, Wu Y. 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. BMC Med. 2023 Nov 3;21(1):416. doi: 10.1186/s12916-023-03130-z.

  PMID: 37919742 DERIVED

• Yuan Y, Jin A, Neal B, Feng X, Qiao Q, Wang H, Zhang R, Li J, Duan P, Cao L, Zhang H, Hu S, Li H, Gao P, Xie G, Yuan J, Cheng L, Wang S, Zhang H, Niu W, Fang H, Zhao M, Gao R, Chen J, Elliott P, Labarthe D, Wu Y. Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial. Nat Med. 2023 Apr;29(4):973-981. doi: 10.1038/s41591-023-02286-8. Epub 2023 Apr 13.

  PMID: 37055566 DERIVED

• 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.

  PMID: 33127634 DERIVED

Study Officials

• Yangfeng Wu, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Epidemiology and Sciences in Clincial Research

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 25, 2017
• Study Start: September 25, 2017
• Primary Completion: October 24, 2020
• Study Completion: May 11, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)