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

NCT ID: NCT01804504

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Food Frequency Questionnaire(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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Nutrition education

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Donglian Cai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donglian Cai, Master

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changhai Hospital ,Second Military Medical University

Locations

Changhai Hospital,Second Military Medical University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

5186272761903

Identifier Type: -

Identifier Source: org_study_id