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A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Feng J He, Queen Mary University of London.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01821144
First Posted: March 29, 2013
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The George Institute for Global Health, China
Peking University, Institute of Child and Adolescent Health
Changzhi Medical College
Information provided by (Responsible Party):
Feng J He, Queen Mary University of London
  Purpose
The study is to test whether an education programme targeted at school children can lower salt intake in children and their families. In this study, the investigators will educate children on how to reduce salt intake, and the investigators will empower children by asking them to deliver the salt reduction message home to their families, particularly children need to persuade the person who does the cooking for the whole family to cut down on the amount of salt used during food preparations. The study will involve children aged about 11 years, and their parents and grandparents in Northern China.

Condition Intervention
Healthy Volunteer Behavioral: Salt reduction Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A School-based Education Programme to Reduce Salt Intake in Children and Their Families (School-EduSalt)

Resource links provided by NLM:


Further study details as provided by Feng J He, Queen Mary University of London:

Primary Outcome Measures:
  • 24-h urinary sodium [ Time Frame: 4.5 month ]
    Difference between the intervention and control group in the change in 24-h urinary sodium from baseline to the end of follow-up for children and for adults


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 4.5 month ]
    Difference between the intervention and control group in the change in blood pressure from baseline to the end of follow-up for children and for adults.


Estimated Enrollment: 840
Study Start Date: March 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
No salt awareness education
Other: Control
No salt awareness education
Experimental: Salt reduction
Salt reduction
Behavioral: Salt reduction
Salt reduction

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Children

Inclusion Criteria:

  • All children in Grade 5 of primary schools (age about 11 years) are eligible for the study.

Exclusion Criteria:

  • Children who do not have lunch or dinner at their own home will be excluded.

Adult family members:

Inclusion Criteria:

  • For each participating child, we will recruit two adult family members. All adult family members who share the same meals with the child are eligible for the study.

Exclusion Criteria:

  • If more than two adults in one family agree to take part in the study, we will select two of them (i.e. one male and one female) in the order of grandparents, parents, uncles and aunties.
  Contacts and Locations
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): NCT01821144


Contacts
Contact: Feng J He, PhD +44 20 7882 6266 f.he@qmul.ac.uk
Contact: Graham A MacGregor +44 20 7882 6217 g.macgregor@qmul.ac.uk

Locations
China, Shanxi
Changzhi Medical College Recruiting
Changzhi, Shanxi, China
Contact: Jianhui Yuan    +86 355 3151438    cyyuanjianhui@sina.com   
Sponsors and Collaborators
Queen Mary University of London
The George Institute for Global Health, China
Peking University, Institute of Child and Adolescent Health
Changzhi Medical College
Investigators
Principal Investigator: Feng He, PhD Queen Mary University of London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Feng J He, Senior Research Fellow, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01821144     History of Changes
Other Study ID Numbers: 008602 QM
First Submitted: March 21, 2013
First Posted: March 29, 2013
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Feng J He, Queen Mary University of London:
dietary salt
24 hour urinary sodium
blood pressure