Obesity Clinical Trial
— HPH| 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 |
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.
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
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
| 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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