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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lunch which is calorie-restricted and low-salt
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Caloric Restriction, Diet, Reducing, Diet, Sodium-Restricted, Body Weight Changes, Energy intake, Feeding Behavior

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Full participation

Two thirds participation

One thirds participation

Arm Description

Participants in this group receive lunch which is calorie-restricted and low-salt during 12 weeks, the total duration of this study.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in weight
Participants will be monitored for up to 12 weeks after intervention

Secondary Outcome Measures

Change from baseline in waist circumference
Participants will be monitored for up to 12 weeks after intervention

Full Information

First Posted
April 20, 2014
Last Updated
April 14, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02416544
Brief Title
The Effectiveness of Low Calorie Low Salt Lunch for Weight Reduction of Workers of a Health Promoting Hospital
Acronym
HPH
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Caloric Restriction, Diet, Reducing, Diet, Sodium-Restricted, Body Weight Changes, Energy intake, Feeding Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full participation
Arm Type
Experimental
Arm Description
Participants in this group receive lunch which is calorie-restricted and low-salt during 12 weeks, the total duration of this study.
Arm Title
Two thirds participation
Arm Type
Experimental
Arm Description
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.
Arm Title
One thirds participation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lunch which is calorie-restricted and low-salt
Intervention Description
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt
Primary Outcome Measure Information:
Title
Change from baseline in weight
Description
Participants will be monitored for up to 12 weeks after intervention
Time Frame
4 weeks, 8 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in waist circumference
Description
Participants will be monitored for up to 12 weeks after intervention
Time Frame
4 weeks, 8 weeks, and 12 weeks
Other Pre-specified Outcome Measures:
Title
Total calorie with sodium intake by 24 hour recall assessment
Description
Participants will be monitored for up to 12 weeks after intervention
Time Frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
Title
Personal history of weight change
Description
Questionnaire about personal history of weight change
Time Frame
Baseline and 12 weeks
Title
Smoking (Questionnaire)
Description
Questionnaire about smoking behavior
Time Frame
Baseline and 12 weeks
Title
Alcohol intake (Questionnaire)
Description
Questionnaire about the frequency and amount of drinking
Time Frame
Baseline and 12 weeks
Title
Stress status (Questionnaire)
Description
Questionnaire about stress status
Time Frame
Baseline and 12 weeks
Title
Physical activities (Questionnaire)
Description
Questionnaire about the frequency and intensity of physical activities
Time Frame
Baseline and 12 weeks
Title
Eating habits (Questionnaire)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Satisfaction regarding low calorie low salt lunch (Questionnaire)
Description
Questionnaire about satisfaction, acceptance and proposition.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju Young Kim, MD. PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21300083
Citation
Morgan PJ, Collins CE, Plotnikoff RC, Cook AT, Berthon B, Mitchell S, Callister R. Efficacy of a workplace-based weight loss program for overweight male shift workers: the Workplace POWER (Preventing Obesity Without Eating like a Rabbit) randomized controlled trial. Prev Med. 2011 May;52(5):317-25. doi: 10.1016/j.ypmed.2011.01.031. Epub 2011 Feb 20.
Results Reference
background
PubMed Identifier
15788796
Citation
Groene O, Jorgensen SJ. Health promotion in hospitals--a strategy to improve quality in health care. Eur J Public Health. 2005 Feb;15(1):6-8. doi: 10.1093/eurpub/cki100. No abstract available.
Results Reference
background
PubMed Identifier
21900443
Citation
Handley MA, Schillinger D, Shiboski S. Quasi-experimental designs in practice-based research settings: design and implementation considerations. J Am Board Fam Med. 2011 Sep-Oct;24(5):589-96. doi: 10.3122/jabfm.2011.05.110067.
Results Reference
background
Links:
URL
http://www.euro.who.int/en/home
Description
World Health Organization, regional office for europe

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

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