Korean Diet Efficacy Clinical Trial
Recruitment status was: Active, not recruiting
- the acceptability of a Korean diet to an Australian overweight and obese population
- which Korean recipes are easily prepared
- the effect of a Korean diet on weight, blood pressure, and metabolic complications of obesity in this population.
|Obesity||Behavioral: Provision of 2 Korean meals per day 6 days per week Behavioral: Western Diet|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||A 13 Week Study to Examine the Effectiveness of the Korean Diet on Weight, Blood Pressure, Metabolic Parameters and Disease Control in an Australian Overweight and Obese Population.|
- 1. To investigate the acceptability of a Korean diet in overweight and obese Australians. [ Time Frame: 13 weeks ]This will be determined at baseline and 4 week timepoints throughout the study by participants completing a Food Acceptability Questionnaire (FAQ). The FAQ addresses 10 components of food acceptability along a 7-point Likeart scale. The FAQ is a recognised instrument for testing food acceptability.
- 2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians. [ Time Frame: 13 weeks ]This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.
- To investigate changes in a number of indicators of metabolic disease in both groups - including anthropometry, Blood Glucose Levels, insulin sensitivity, lipid profiles, liver function, hormone function and inflammatory markers. [ Time Frame: 13 weeks ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Korean Diet
Provision of 2 Korean meals per day, 6 days per week
Behavioral: Provision of 2 Korean meals per day 6 days per week
At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Korean diet group will pick up lunch and evening meals Monday-Friday. Raw ingredients and cooking instructions will also be provided on friday for saturday meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.
Active Comparator: Western Diet
Lifestyle counseling, dietary advice, grocery vouchers
Behavioral: Western Diet
At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Western diet group will be provided with a Western recipe cookbook and food vouchers (weekly) to purchase the necessary ingredients for the Western meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.
The primary endpoint (Korean diet acceptability) will be assessed by reliability tested questionnaire, dietary compliance, and quantities of food returned over the 12 weeks.
Analysis of differences in weight loss will be based on all participants with a baseline and a 12-week weight assessment. In order to investigate the impact of missing data, all subjects will be analysed using last weight observation carried forward and baseline weight carried forward.
Other secondary endpoints will determine the effect of the Korean diet on blood pressure, metabolic parameters and chronic metabolic disease control in the Australian population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124071
|Australia, New South Wales|
|The University of Sydney|
|Sydney, New South Wales, Australia, 2006|
|Principal Investigator:||Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP||University of Sydney|