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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: ISRCTN
Last refreshed on: 6 July 2020
Main ID:  ISRCTN13602313
Date of registration: 10/04/2013
Prospective Registration: No
Primary sponsor: Monash University (Australia)
Public title: Evaluation of a a weight management program for young people
Scientific title: Evaluation of a 12 week commercial weight management program for adolescents
Date of first enrolment: 18/03/2013
Target sample size: 140
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN13602313
Study type:  Interventional
Study design:  Randomised parallel design (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Maxine    Bonham
Address:  Level 1, 264 Ferntree Gully Rd 3168 Notting Hill Australia
Telephone: -
Email: maxine.bonham@monash.edu
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Overweight and obesity in adolescents
Nutritional, Metabolic, Endocrine
Obesity
Intervention(s)
The intervention group will engage in the 12 week JenMe program, whereas the wait-listed group will delay their enrolment for 12 weeks.
Primary Outcome(s)

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
Secondary Outcome(s)

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
Secondary ID(s)
N/A
Source(s) of Monetary Support
Jenny Craig Weight Loss Centres Pty Ltd.
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Monash University Human Research Ethics Committee ¨C conditional approval - Project Number - CF11/3687 - 2011001940
Results
Results available: Yes
Date Posted:
Date Completed: 18/03/2015
URL:
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