Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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6 July 2020 |
Main ID: |
ISRCTN13602313 |
Date of registration:
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10/04/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of a a weight management program for young people
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Scientific title:
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Evaluation of a 12 week commercial weight management program for adolescents |
Date of first enrolment:
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18/03/2013 |
Target sample size:
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140 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN13602313 |
Study type:
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Interventional |
Study design:
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Randomised parallel design (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Maxine
Bonham |
Address:
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Level 1, 264 Ferntree Gully Rd
3168
Notting Hill
Australia |
Telephone:
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- |
Email:
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maxine.bonham@monash.edu |
Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Adolescents seeking weight management aged 13 to 17 years 2. BMI z-score ? 1.282 3. Available to complete the 12 week program in a maximum of 14 weeks
Exclusion criteria: 1. Less than 13 years of age 2. Over 17 years and 2 months of age at time of commencement in study 3. Pregnant or breastfeeding 4. A health condition - Adolescents joining the Jenny Craig program are screened by a company doctor and a health checklist completed. Potential clients are not permitted to enrol in the program if they have a health condition that that requires medication or ongoing health screening. If necessary, the company doctor will liaise between the company and the potential client's GP in order to ascertain medical history and thus advise Jenny Craig as to an individual's suitability to join the program.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overweight and obesity in adolescents Nutritional, Metabolic, Endocrine Obesity
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Intervention(s)
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The intervention group will engage in the 12 week JenMe program, whereas the wait-listed group will delay their enrolment for 12 weeks.
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Primary Outcome(s)
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1. Change in body mass index z-score 2. Change in weight to height ratio Measured at baseline, 12 weeks and nine months from baseline
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Secondary Outcome(s)
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1. Change in activity levels will be measured using pedometers and an activity diary 2. Change in behaviour and self esteem will be measured using validated questionnaires 3. Changes in body composition will be measured using DXA 4. Changes in cardiometabolic risk factors in blood plasma will be measured in blood and will include fasting glucose, triacylglycerols and cholesterol
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Source(s) of Monetary Support
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Jenny Craig Weight Loss Centres Pty Ltd.
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Ethics review
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Status:
Approval date:
Contact:
Monash University Human Research Ethics Committee ¨C conditional approval - Project Number - CF11/3687 - 2011001940
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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18/03/2015 |
URL:
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