The Effectiveness of Low Calorie Low Salt Lunch for Weight Reduction of Workers of a Health Promoting Hospital (HPH)

April 14, 2015 updated by: Ju Young Kim, Seoul National University Hospital
The aim of this study is to evaluate the effectiveness of Low Calorie Low Salt Lunch for Weight Reduction in overweight or obese workers of a health promoting hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight or obese
  • Hospital workers

Exclusion Criteria:

  • History of major medical problems such as heart disease in the last 6 months
  • Orthopaedic or joint problems that would be a barrier to physical activity
  • Pregnancy
  • Recent weight change of ≥10% of baseline weight
  • Taking medications that might affect body weight
  • Participation in other program about weight control
  • Alcohol or substance abuser
  • Other uncontrolled psychiatric problems
  • Eating disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full participation
Participants in this group receive lunch which is calorie-restricted and low-salt during 12 weeks, the total duration of this study.
Other: Lunch which is calorie-restricted and low-salt
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt
Experimental: Two thirds participation
Participants in this group starts lunch which is calorie-restricted and low-salt after 4 weeks from the beginning of the study and maintain the diet during 8 weeks.
Other: Lunch which is calorie-restricted and low-salt
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt
Experimental: One thirds participation
Participants in this group starts lunch which is calorie-restricted and low-salt after 8 weeks from the beginning of the study and maintain the diet during 4 weeks.
Other: Lunch which is calorie-restricted and low-salt
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in weight
Time Frame: 4 weeks, 8 weeks, and 12 weeks
Participants will be monitored for up to 12 weeks after intervention
4 weeks, 8 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in waist circumference
Time Frame: 4 weeks, 8 weeks, and 12 weeks
Participants will be monitored for up to 12 weeks after intervention
4 weeks, 8 weeks, and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total calorie with sodium intake by 24 hour recall assessment
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will be monitored for up to 12 weeks after intervention
Baseline, 4 weeks, 8 weeks, and 12 weeks
Personal history of weight change
Time Frame: Baseline and 12 weeks
Questionnaire about personal history of weight change
Baseline and 12 weeks
Smoking (Questionnaire)
Time Frame: Baseline and 12 weeks
Questionnaire about smoking behavior
Baseline and 12 weeks
Alcohol intake (Questionnaire)
Time Frame: Baseline and 12 weeks
Questionnaire about the frequency and amount of drinking
Baseline and 12 weeks
Stress status (Questionnaire)
Time Frame: Baseline and 12 weeks
Questionnaire about stress status
Baseline and 12 weeks
Physical activities (Questionnaire)
Time Frame: Baseline and 12 weeks
Questionnaire about the frequency and intensity of physical activities
Baseline and 12 weeks
Eating habits (Questionnaire)
Time Frame: Baseline and 12 weeks
Eating habits will be assessed by asking how often participants eat breakfast and intake different food groups such as fruits, vegetables, dairy products, noodles, cereals, fish, pork, meat products, carbonated beverages and tofu.
Baseline and 12 weeks
Satisfaction regarding low calorie low salt lunch (Questionnaire)
Time Frame: Baseline and 12 weeks
Questionnaire about satisfaction, acceptance and proposition.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ju Young Kim, MD. PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 20, 2014

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1403-244-005 (Other Identifier: SeoulNUH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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