NCT02416544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

April 20, 2014

Last Update Submit

April 14, 2015

Conditions

OverweightObesity

Keywords

OverweightObesityCaloric RestrictionDiet, ReducingDiet, Sodium-RestrictedBody Weight ChangesEnergy intakeFeeding Behavior

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in weight

    Participants will be monitored for up to 12 weeks after intervention

    4 weeks, 8 weeks, and 12 weeks

Secondary Outcomes (1)

  • Change from baseline in waist circumference

    4 weeks, 8 weeks, and 12 weeks

Other Outcomes (8)

  • Total calorie with sodium intake by 24 hour recall assessment

    Baseline, 4 weeks, 8 weeks, and 12 weeks

  • Personal history of weight change

    Baseline and 12 weeks

  • Smoking (Questionnaire)

    Baseline and 12 weeks

  • +5 more other outcomes

Study Arms (3)

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.

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.

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.

Other: Lunch which is calorie-restricted and low-salt

Interventions

Lunch which is calorie-restricted and low-saltOTHER

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

Full participationOne thirds participationTwo thirds participation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight or obese
  • Hospital workers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 21300083BACKGROUND

  • 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.

    PMID: 15788796BACKGROUND

  • 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.

    PMID: 21900443BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightObesityBody Weight ChangesFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Ju Young Kim, MD. PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 20, 2014

First Posted

April 15, 2015

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

KR(1)