Nutrition Education on the Metabolic Syndrome of Subjects Who Are Frequently Eating Out

Metabolic Syndrome Clinical Trial

Official title:

Survey on Eating Out Behavior and Dietary Structure in Urban Chinese Citizens and the Effect of Nutrition Education

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01804504
• Other study ID #: 5186272761903
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 25, 2013
• Last updated: March 5, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: March 2013
• Source: Second Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The project is aimed at investigating the effect of nutrition education on knowledge, attitude and practice (KAP)of subjects who are frequently eating out, and the effect on metabolic parameters.

Description:

The project is aimed at investigating the dietary structure and frequencies of eating out via a cross-sectional study, on the basis of which a randomized, parallel controlled trials is to be carried out.The purpose is to evaluate the effect on metabolic parameters.

Hypotheses to be tested:Nutrition education has the effect of improving the metabolic parameters of subjects who are frequently eating out.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 78
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Shanghai urban citizens

• Male or female 18 to 25 years of age;

• Frequently eat out(eat out 3 or more times per week);

• Clinical diagnosis of Metabolic Syndrome(Meet 3 or more Diagnostic criteria); A. Abdominal obesity: waist circumference>90cm ( M ), and>85cm( F ); B. Dyslipidemia:triglyceride=1.7mmol/L; C. HDL-C < 1.04mmol/L; D. hypertension: blood pressure= 130/85mm Hg ( or have been diagnosed hypertension); E. Hyperglycemia : FPG=6.1mmol/L and ( or ) 2-hour postprandial blood glucose=7.8mmol/L and ( or ) have been diagnosed with diabetes;

• Signed written informed consent ;

• Can attend lectures.

Exclusion Criteria:

• Pregnant woman;

• Temporary resident population;

• Participating in another clinical trial 6 months before randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Nutrition education
The intervention group will be sent out a series of education materials, be arranged to attend lectures(once a month), dietary guidance or nutrition consultation at regular intervals(once every 2 weeks).

Locations

Country	Name	City	State
China	Changhai Hospital,Second Military Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.	Baseline and 24 weeks	No
Secondary	Change in Blood pressure		Baseline and 24 weeks	No
Secondary	Change in waist circumference, waist hip ratio, waist to height	Waist, hip circumference and height was measured using a plastic tape to the nearest 0.1 cm	Baseline and 24 weeks	No
Secondary	Change in Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm Change in fasting blood glucose		Baseline and 24 weeks	No
Secondary	Change in serum triglyceride, cholesterol, HDL, LDL		Baseline and 24 weeks	No