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Trial record 13 of 685 for:    adolescent health | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Queen Mary University of London
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01821144
First received: March 21, 2013
Last updated: March 26, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Queen Mary University of London:

Primary Outcome Measures:
  • 24-h urinary sodium [ Time Frame: 4.5 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 21, 2013
Last Updated: March 26, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 20, 2014