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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02416544
Other study ID # B-1403-244-005
Secondary ID B-1403-244-005
Status Completed
Phase N/A
First received April 20, 2014
Last updated April 14, 2015
Start date April 2014
Est. completion date October 2014

Study information

Verified date April 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Lunch which is calorie-restricted and low-salt
Comparison of different duration of feeding lunch which is calorie-restricted and low-salt

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Total calorie with sodium intake by 24 hour recall assessment Participants will be monitored for up to 12 weeks after intervention Baseline, 4 weeks, 8 weeks, and 12 weeks No
Other Personal history of weight change Questionnaire about personal history of weight change Baseline and 12 weeks No
Other Smoking (Questionnaire) Questionnaire about smoking behavior Baseline and 12 weeks
Other Alcohol intake (Questionnaire) Questionnaire about the frequency and amount of drinking Baseline and 12 weeks
Other Stress status (Questionnaire) Questionnaire about stress status Baseline and 12 weeks
Other Physical activities (Questionnaire) Questionnaire about the frequency and intensity of physical activities Baseline and 12 weeks
Other Eating habits (Questionnaire) 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
Other Satisfaction regarding low calorie low salt lunch (Questionnaire) Questionnaire about satisfaction, acceptance and proposition. Baseline and 12 weeks No
Primary Change from baseline in weight Participants will be monitored for up to 12 weeks after intervention 4 weeks, 8 weeks, and 12 weeks No
Secondary Change from baseline in waist circumference Participants will be monitored for up to 12 weeks after intervention 4 weeks, 8 weeks, and 12 weeks No
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