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Trial registered on ANZCTR
Registration number
ACTRN12610000111077
Ethics application status
Approved
Date submitted
28/01/2010
Date registered
3/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the Choose Health Program: A Healthy Lifestyle Program for Overweight and Obese Adolescents.
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Scientific title
The efficacy of a cognitive behavioural lifestyle intervention in improving body composition and cardiovascular fitness in overweight and obese adolescents. A wait-listed randomised controlled trial.
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Secondary ID [1]
1344
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Nil.
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity in Adolescents
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Condition category
Condition code
Diet and Nutrition
256846
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Choose Health Program is a cognitive behavioural lifestyle intervention developed for the purpose of this study. Intervention was conducted on an individual basis and delivered by a clinician with a background in psychology. The treatment phase consisted of 12 one-hour face-to-face sessions and one phone call session. The first ten treatment sessions were conducted weekly. The remaining sessions were conducted fortnightly. The focus of each treatment phase session is listed below.
1 Psycho-education
2 Eating Behaviour
3 Physical Activity
4 Healthy Food Choices
5 Physical Activity
6 Behaviour Charts and Barriers
7 Recognising Thoughts and Emotions
8 Helpful Thoughts and Emotions
9 Assertive Communication
10 Problem Solving and Planning
11 Staying on Track
Phonecall - Maintaining Change
12 Maintenance and Closure
Both parents and adolescents were required to attend the first six treatment sessions. Adolescents were then given the choice of attending the remaining sessions alone, or with the support of a parent. Participants received written information relating to each session with the opportunity for discussion, questions and practice of the strategies during the session. Participants were asked to record their use of these strategies between sessions.
The nutritional component of the intervention aimed to promote eating habits consistent with the Australian Guide to Healthy Eating. The physical activity component of the intervention aimed to promote physical activity habits consistent with the Australian Physical Activity Guidelines for Children and Young People.
Following the treatment phase families participated in the maintenance phase of intervention. This consisted of two 1-hour maintenance clinic sessions (conducted 3 and 6 months post-treatment) and seven 15-minute maintenance phone call sessions (conducted fortnightly and then monthly).
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Intervention code [1]
255925
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Behaviour
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Intervention code [2]
255926
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Lifestyle
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Intervention code [3]
255927
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Treatment: Other
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Comparator / control treatment
Wait-List Control: After receipt of consent and completion of pre-treatment assessments participants randomised to the control group did not receive any intervention until after the 6 month wait-list period. After 6 months they were asked to repeat assessments, and offered the opportunity to recieve treatment. Thus wait-list control data is not available at the 12-month.
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Control group
Active
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Outcomes
Primary outcome [1]
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Body composition (total and truncal) as measured by whole body scanning using a dual-energy X-ray absorptiometry apparatus (Lunar DPX densitometer).
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Assessment method [1]
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Timepoint [1]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Primary outcome [2]
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Body Mass Index (BMI) (kg/m2), calculated from measured height and weight, and converted to BMI-for-age z-score and percentile and International Obesity Task Force defined weight category.
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Assessment method [2]
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Timepoint [2]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Primary outcome [3]
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Cardiovascular fitness as measured by laboratory-based cycle ergometer (Lode N.V Groningen, Netherlands).
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Assessment method [3]
257720
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Timepoint [3]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [1]
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Energy intake and diet quality measured using a 7-day weighed food diary(electronic scales to measure weights, Australian Standard measures of volume) and analysed using the FoodWorks Professional Edition 2005 (Version 4) program (Xyris Software Pty. Ltd.) and the AusNut food composition database.
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Assessment method [1]
263067
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Timepoint [1]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [2]
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Energy expenditure and physical activity measured using Manufacturing Technologies Incorporated Actigraph (Model 7164), worn on the right hip, with an epoch set at 1 minute, during the 7-day monitoring period.
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Assessment method [2]
263068
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Timepoint [2]
263068
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [3]
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Self-reported eating habits as measured by the Fat, Fruit and Vegetables Diet Questionnaire (Kristal et al., 1999), the dietary questions from the Centre for Disease Control Youth Behavioral Risk Survey (Serdula et.al., 1993; 1996), and the Adolescent Dieting Scale (Patton et al., 1997).
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Assessment method [3]
263069
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Timepoint [3]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [4]
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Self-reported daily physical activity and sedentary behaviour measured using the Self-Administered Physical Activity Checklist (Sallis et al., 1993).
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Assessment method [4]
263070
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Timepoint [4]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [5]
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Resting metabolic rate determined via indirect caloriometry. Gas exchange (the amount of oxygen consumed and carbon dioxide produced) was measured on a MedGraphics metabolic measurement system (St. Paul, Minn., USA). Resting oxygen consumption and respiratory exchange ratio were used to calculate resting metabolic rate.
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Assessment method [5]
263071
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Timepoint [5]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [6]
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Cardiovascular fitness determined via completion of a multi-stage shuttle test (Leger & Lambert, 1982).
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Assessment method [6]
263072
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Timepoint [6]
263072
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [7]
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Eating and weight related psychopathology as measured by the Eating Disorders Inventory-II (Garner, 1990).
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Assessment method [7]
263073
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Timepoint [7]
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [8]
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Psychopathology as measured by the Depression Anxiety Stress Scale (Lovibond & Lovibond, 1995).
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Assessment method [8]
263074
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Timepoint [8]
263074
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [9]
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Self-esteem as measured by the Rosenberg Self-Esteem Scale (Rosenberg, 1965).
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Assessment method [9]
263076
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Timepoint [9]
263076
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [10]
263077
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Social support as measured by the Perceived Social Support Scale (Procidano & Heller, 1983).
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Assessment method [10]
263077
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Timepoint [10]
263077
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [11]
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Family interaction and communication as measured by the Parent Adolescent Communication Scale (Barnes & Olsen, 1982) and the Family Problem Solving Communication Index (McCubbin et al., 1988).
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Assessment method [11]
263078
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Timepoint [11]
263078
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [12]
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Parenting approach as measured by the Parenting Scale (Arnold, et al., 1993; Irvine et al., 1999).
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Assessment method [12]
263079
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Timepoint [12]
263079
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [13]
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Social skills as measured by the Social Skills Questionnaire (Spence, 1995) and the Social Competence Questionnaire (Spence, 1995).
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Assessment method [13]
263080
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Timepoint [13]
263080
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [14]
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Negative cognitions as measured by the Automatic Thoughts Questionnaire (Hollon & Kendall, 1980).
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Assessment method [14]
263081
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Timepoint [14]
263081
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [15]
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Knowledge of factors related to overweight and obesity as measured by the Obesity Knowledge Test (McArther et al., 2001).
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Assessment method [15]
263082
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Timepoint [15]
263082
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [16]
263083
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The involvement of family and friends in adolescents' adoption of health behaviour as measured by the Family and Friend Influence on Health Behaviour Scale developed for the purpose of this study.
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Assessment method [16]
263083
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Timepoint [16]
263083
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Secondary outcome [17]
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Hip and waist circumference measurements taken from the right side of the body to the nearest millimetre. These measures will also be used to calculate waist:hip and waist:height ratios.
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Assessment method [17]
263084
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Timepoint [17]
263084
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Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
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Eligibility
Key inclusion criteria
Participants were eligible for the study if they were aged 11 to 19 years, were overweight or obese according to the International Obesity Task Force definitions, and living with a parent or adult caregiver who was prepared to be involved in treatment.
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Minimum age
11
Years
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Maximum age
19
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants were excluded from the study if they had an intellectual or physical disability that prevented them from participating in the program.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information about the trial was circulated throughout the community and participants were asked to call to register their interest. Parents were then contacted by telephone and a brief intake questionnaire was completed to determine eligibility. Eligible families were asked to return the consent form to register for the study. Registered parent and adolescent participants completed an initial interview (the first 34 participants received a standard assessment interview, the remaining 29 participants a motivational interview) at which eligibility was confirmed. Participants then completed baseline assessments (self-report questionnaires, monitoring of eating and activity habits, physical assessments). After completion of all baseline assessments participants were randomly allocated to the treatment or wait-list control condition. Two-thirds of participants were allocated to the treatment condition, one-third to the wait-list condition. The assessor selected two of three numbers to indicate treatment condition allocation. Participants were asked to select a number and this was used to randomly allocate participants to the treatment or wait-list control condition. Allocation was clearly explained to participants. Eligibility assessment and random allocation were conducted by separate members of the research team. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The assessor selected two of three numbers to indicate treatment condition allocation. After completion of all baseline assessments participants were asked to select a number and this was used to randomly allocate participants to the treatment or wait-list control condition.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
All participants completed baseline assessments prior to allocation to the treatment or wait-list control condition. Those allocated to the treatment condition commenced treatment immediately, those allocated to the wait-list control condition were told that they would be contacted in 6 months. All assessments were repeated after 6 months (post-treatment). The wait-list control group were then offered treatment. Those in the treatment group continued on to the maintenance phase of the intervention and repeated assessments at 12 months (post-maintenance). This allows for comparison between the treatment and wait-list control condition at post-treatment, and comparison of baseline, post-treatment and post-maintenance assessments for those receiving treatment.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
9/01/2003
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
63
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
2514
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3083
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Recruitment postcode(s) [2]
2515
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3001
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Funding & Sponsors
Funding source category [1]
256424
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University
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Name [1]
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RMIT University
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Address [1]
256424
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Plenty Road
Bundoora VIC 3083
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Country [1]
256424
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Australia
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Primary sponsor type
Individual
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Name
Leah Brennan
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Address
Monash University
Clayton VIC 3800
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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RMIT University
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Address [1]
255727
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Plenty Road
Bundoora VIC 3083
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Country [1]
255727
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258477
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RMIT University Human Research Ethics Committee
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Ethics committee address [1]
258477
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RMIT University Plenty Road Bundoora VIC 3083
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Ethics committee country [1]
258477
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Australia
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Date submitted for ethics approval [1]
258477
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Approval date [1]
258477
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14/11/2002
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Ethics approval number [1]
258477
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No 20/02
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Ethics committee name [2]
258478
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Department of Human Services Radiation Safety Unit
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Ethics committee address [2]
258478
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120 Spencer Street Melbourne, VIC 3001
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Ethics committee country [2]
258478
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Australia
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Date submitted for ethics approval [2]
258478
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Approval date [2]
258478
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09/01/2003
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Ethics approval number [2]
258478
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Number not provided.
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Ethics committee name [3]
258479
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Department of Education and Training
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Ethics committee address [3]
258479
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2 Treasury Place East Melbourne, VIC 3002
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Ethics committee country [3]
258479
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Australia
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Date submitted for ethics approval [3]
258479
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Approval date [3]
258479
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01/12/2002
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Ethics approval number [3]
258479
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sos02267
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Ethics committee name [4]
258480
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Catholic Education Office
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Ethics committee address [4]
258480
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James Goold House 228 Victoria Parade East Melbourne VIC 3002
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Ethics committee country [4]
258480
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Australia
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Date submitted for ethics approval [4]
258480
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Approval date [4]
258480
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02/11/2002
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Ethics approval number [4]
258480
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GE02/0009
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Summary
Brief summary
This study explored the efficacy of the Choose Health Program, a cognitive behavioural lifestyle program for overweight and obese adolescents. The program aims to increase participant's knowledge and skills so they are better able to make healthy lifestyle choices. It was delivered by a psychologist and conducted with individual families with adolescents and their parents attending sessions together. It was predicted that participation in the program would result in improved body composition and cardiovascular fitness, healthier eating and physical activity behaviours, and improved psychosocial wellbeing.
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Trial website
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Trial related presentations / publications
Publications Brennan L, Walkley, J, Fraser, S, Greenway, K. & Wilks R, (2008). Motivational interviewing and cognitive behaviour therapy in the treatment of adolescent overweight and obesity: Study design and methodology. Contemporary Clinical Trials, 29, 359-375. Brennan, L., Wilks, R., Walkley, J., Fraser, S., & Greenway, K. (2006). Efficacy of cognitive behaviour therapy in the treatment of overweight and obese adolescents. [Abstract]. Obesity Reviews, 7 (Suppl. 2), 88-89. Brennan, L, Wilks, R., & Walkley, J.W. (2005). Is BMI classification of overweight and obesity useful in adolescents with high body fat levels? [Abstract]. Medicine & Science in Sports and Exercise, 37(Suppl. 5), s303. Fraser, S.F., Brennan, L., Wilks, R., Greenway, K., & Walkley J. (2005). Peak power output can be used to estimate VO2 peak in obese adolescent males & females [Abstract]. Medicine & Science in Sports and Exercise, in press. 37(Suppl. 5), s20. Oral Presentations Brennan, L., Walkley, J., Fraser, S., Greenway, K., Wilks, R., & Mann, N. (September 2007). Biopsychosocial outcomes of the original choose health study. ASSO National Conference. Canberra. Brennan, L., Wilks, R., Walkley, J., Fraser, S., & Greenway, K. (October 2006). Efficacy of cognitive behaviour therapy in the treatment of overweight and obese adolescents. International Obesity Congress. Sydney. Brennan, L., Wilks, R., & Walkley, J. (April 2005). Using CBT to treat overweight and obesity in adolescents. AACBT National Conference. Melbourne. Brennan, L., Wilks, R., & Walkley, J. (February 2005). Using psychological strategies in the treatment of adolescent overweight and obesity. Australian Society for Behavioural Health Medicine. Melbourne. Brennan, L., Wilks, R., & Walkley, J. (November 2004). Treating overweight and obesity in adolescents. APS College of Clinical Psychologists Conference. Sydney. Brennan, L., Wilks, R., & Walkley, J. (October 2003). The effect of cognitive behaviour therapy and motivational interviewing on overweight and obesity in adolescents. ASSO National Conference, Sydney. Poster Presentations Walkley, J., Brennan, L., Tsiros, M., Sinn, N., Buckley, J., Howe, P., Coates, A., Mallows, R., Lukeis, S., Fraser, S., Spargo, F., Taylor, L., Lante, K., & Greenway, K. (November 2008). Physical activity and cardiovascular fitness in overweight and obese adolescents. Australian Health and Medical Research Congress & ANZOS National Conference. Brisbane. Brennan, L., Walkley, J., Fraser, S., Greenway, K., & Mann, N. (September 2007) Future directions for the Choose Health Program: Extension and dissemination of an efficacious treatment for adolescent obesity. ASSO National Conference. Canberra. Walkley, J., Brennan, L., Fraser, S., Greenway, K., Lante, K., Mann, N., Tsiros, M., Sinn, N., Coates, A., Howe, P., & Buckley, J. (September 2007) Physical activity behaviours of overweight and obese adolescents. ASSO National Conference. Canberra. Brennan, L., Wilks, R,. & Walkley, J. (October 2005). The Choose Health Program and the treatment of overweight and obese adolescents. ASSO National Conference. Adelaide. Brennan, L., Wilks, R,. & Walkley, J. (October 2005). Dissemination of the CHOOSE HEALTH program. ASSO National Conference. Adelaide. Brennan, L., Walkley, J., & Wilks, R. (June 2005). Is BMI classification of overweight and obesity useful in adolescents with high body fat levels? American College of Sports Medicine International Conference. Fraser, S., Brennan, L., Wilks, R., & Walkley, J. (June 2005). Peak power output can be used to estimate VO2 peak in obese adolescent males & females. American College of Sports Medicine International Conference.
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Public notes
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Contacts
Principal investigator
Name
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Address
30774
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Country
30774
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Phone
30774
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Fax
30774
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Email
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Contact person for public queries
Name
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Leah Brennan
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Address
14021
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Monash University
Clayton VIC 3800
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Country
14021
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Australia
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Phone
14021
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+61 3 9902 0873
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Fax
14021
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Email
14021
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[email protected]
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Contact person for scientific queries
Name
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Leah Brenann
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Address
4949
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Monash University
Clayton VIC 3800
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Country
4949
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Australia
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Phone
4949
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+61 3 9902 0873
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Fax
4949
0
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Email
4949
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Does motivational interviewing improve retention or outcome in cognitive behaviour therapy for overweight and obese adolescents?.
2016
https://dx.doi.org/10.1016/j.orcp.2015.08.019
N.B. These documents automatically identified may not have been verified by the study sponsor.
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