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

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Nutrition education

• Registration Number: NCT01804504
• Lead Sponsor: Second Military Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-02-25
• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-05
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition education	Nutrition education	FFQ and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores. Physical examination and biochemical examination before and after the trial. Do nutrition education

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	Baseline and 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Blood pressure	Baseline and 24 weeks
Change in waist circumference, waist hip ratio, waist to height	Baseline and 24 weeks	Waist, hip circumference and height was measured using a plastic tape to the nearest 0.1 cm
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
Change in serum triglyceride, cholesterol, HDL, LDL	Baseline and 24 weeks

Trial Locations

Locations (1)

Changhai Hospital,Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China