OverweightHPHNCT02416544
The Effectiveness of Low Calorie Low Salt Lunch for Weight Reduction of Workers of a Health Promoting Hospital
A study testing Lunch which is calorie-restricted and low-salt in people with Overweight and Obesity, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lunch which is calorie-restricted and low-salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Overweight or obese
- Hospital workers
Who cannot join
- 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
Show all 9Show fewer
- Alcohol or substance abuser
- Other uncontrolled psychiatric problems
- Eating disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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.
- Conditions
- Overweight, Obesity
- Being tested
- Lunch which is calorie-restricted and low-salt
- Keywords
- Overweight, Obesity, Caloric Restriction, Diet, Reducing, Diet, Sodium-Restricted, Body Weight Changes, Energy intake, Feeding Behavior
- Medical subject headings
- Overweight, Obesity, Body Weight Changes, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunch which is calorie-restricted and low-saltOther
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt
| Study group | Role | What they receive |
|---|---|---|
| Full participation | Experimental | Participants in this group receive lunch which is calorie-restricted and low-salt during 12 weeks, the total duration of this study. Receives: Other: Lunch which is calorie-restricted and low-salt |
| Two thirds participation | Experimental | 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. Receives: Other: Lunch which is calorie-restricted and low-salt |
| One thirds participation | Experimental | 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. Receives: Other: Lunch which is calorie-restricted and low-salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight
Participants will be monitored for up to 12 weeks after intervention
Measured: 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes (1)
Change from baseline in waist circumference
Participants will be monitored for up to 12 weeks after intervention
Measured: 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Young Kim, Seoul National University Hospital
- Investigators
- Ju Young Kim, MD. PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416544
- Sponsor's protocol ID
- B-1403-244-005
- Other IDs
- B-1403-244-005
- Acronym
- HPH
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2014
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21300083Groene 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.
PubMed 15788796Handley 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.
PubMed 21900443
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low Calorie Low Salt Lunch for Weight Reduction of Workers of a Health Promoting Hospital
- ClinicalTrials.gov ID
- NCT02416544
- Acronym / sponsor ID
- HPH / B-1403-244-005
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Caloric Restriction, Diet, Reducing, Diet, Sodium-Restricted, Body Weight Changes, Energy intake, Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full participation | Experimental | Other: Lunch which is calorie-restricted and low-saltParticipants in this group receive lunch which is calorie-restricted and low-salt during 12 weeks, the total duration of this study. |
| Two thirds participation | Experimental | Other: Lunch which is calorie-restricted and low-saltParticipants 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. |
| One thirds participation | Experimental | Other: Lunch which is calorie-restricted and low-saltParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight or obese
- Hospital workers
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lunch which is calorie-restricted and low-saltComparison of different duration of feeding lunch which is calorie-restricted and low-salt | Other | Full participation, One thirds participation, Two thirds participation |
Primary outcome
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
1 secondary outcome
Change from baseline in waist circumference
Time frame: 4 weeks, 8 weeks, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Background: PubMed 21300083Morgan 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.
- Background: PubMed 15788796Groene 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.
- Background: PubMed 21900443Handley 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.
- World Health Organization, regional office for europeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Young Kim, MD. PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lunch which is calorie-restricted and low-salt in people with Overweight and Obesity, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight (time frame: 4 weeks, 8 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02416544, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.