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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.
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.
Secondary ID [1] 1344 0
Nil.
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity in Adolescents 256689 0
Condition category
Condition code
Diet and Nutrition 256846 256846 0 0
Obesity

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 255925 0
Behaviour
Intervention code [2] 255926 0
Lifestyle
Intervention code [3] 255927 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 257718 0
Body composition (total and truncal) as measured by whole body scanning using a dual-energy X-ray absorptiometry apparatus (Lunar DPX densitometer).
Timepoint [1] 257718 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Primary outcome [2] 257719 0
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.
Timepoint [2] 257719 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Primary outcome [3] 257720 0
Cardiovascular fitness as measured by laboratory-based cycle ergometer (Lode N.V Groningen, Netherlands).
Timepoint [3] 257720 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [1] 263067 0
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.
Timepoint [1] 263067 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [2] 263068 0
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.
Timepoint [2] 263068 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [3] 263069 0
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).
Timepoint [3] 263069 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [4] 263070 0
Self-reported daily physical activity and sedentary behaviour measured using the Self-Administered Physical Activity Checklist (Sallis et al., 1993).
Timepoint [4] 263070 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [5] 263071 0
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.
Timepoint [5] 263071 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [6] 263072 0
Cardiovascular fitness determined via completion of a multi-stage shuttle test (Leger & Lambert, 1982).
Timepoint [6] 263072 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [7] 263073 0
Eating and weight related psychopathology as measured by the Eating Disorders Inventory-II (Garner, 1990).
Timepoint [7] 263073 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [8] 263074 0
Psychopathology as measured by the Depression Anxiety Stress Scale (Lovibond & Lovibond, 1995).
Timepoint [8] 263074 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [9] 263076 0
Self-esteem as measured by the Rosenberg Self-Esteem Scale (Rosenberg, 1965).
Timepoint [9] 263076 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [10] 263077 0
Social support as measured by the Perceived Social Support Scale (Procidano & Heller, 1983).
Timepoint [10] 263077 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [11] 263078 0
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).
Timepoint [11] 263078 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [12] 263079 0
Parenting approach as measured by the Parenting Scale (Arnold, et al., 1993; Irvine et al., 1999).
Timepoint [12] 263079 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [13] 263080 0
Social skills as measured by the Social Skills Questionnaire (Spence, 1995) and the Social Competence Questionnaire (Spence, 1995).
Timepoint [13] 263080 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [14] 263081 0
Negative cognitions as measured by the Automatic Thoughts Questionnaire (Hollon & Kendall, 1980).
Timepoint [14] 263081 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [15] 263082 0
Knowledge of factors related to overweight and obesity as measured by the Obesity Knowledge Test (McArther et al., 2001).
Timepoint [15] 263082 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [16] 263083 0
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.
Timepoint [16] 263083 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).
Secondary outcome [17] 263084 0
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.
Timepoint [17] 263084 0
Treatment and control group at baseline and 6 months (post-treatment), treatment group only at 12 months (post-maintenance).

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.
Minimum age
11 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2514 0
3083
Recruitment postcode(s) [2] 2515 0
3001

Funding & Sponsors
Funding source category [1] 256424 0
University
Name [1] 256424 0
RMIT University
Country [1] 256424 0
Australia
Primary sponsor type
Individual
Name
Leah Brennan
Address
Monash University
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 255727 0
University
Name [1] 255727 0
RMIT University
Address [1] 255727 0
Plenty Road
Bundoora VIC 3083
Country [1] 255727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258477 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 258477 0
Ethics committee country [1] 258477 0
Australia
Date submitted for ethics approval [1] 258477 0
Approval date [1] 258477 0
14/11/2002
Ethics approval number [1] 258477 0
No 20/02
Ethics committee name [2] 258478 0
Department of Human Services Radiation Safety Unit
Ethics committee address [2] 258478 0
Ethics committee country [2] 258478 0
Australia
Date submitted for ethics approval [2] 258478 0
Approval date [2] 258478 0
09/01/2003
Ethics approval number [2] 258478 0
Number not provided.
Ethics committee name [3] 258479 0
Department of Education and Training
Ethics committee address [3] 258479 0
Ethics committee country [3] 258479 0
Australia
Date submitted for ethics approval [3] 258479 0
Approval date [3] 258479 0
01/12/2002
Ethics approval number [3] 258479 0
sos02267
Ethics committee name [4] 258480 0
Catholic Education Office
Ethics committee address [4] 258480 0
Ethics committee country [4] 258480 0
Australia
Date submitted for ethics approval [4] 258480 0
Approval date [4] 258480 0
02/11/2002
Ethics approval number [4] 258480 0
GE02/0009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30774 0
Address 30774 0
Country 30774 0
Phone 30774 0
Fax 30774 0
Email 30774 0
Contact person for public queries
Name 14021 0
Leah Brennan
Address 14021 0
Monash University
Clayton VIC 3800
Country 14021 0
Australia
Phone 14021 0
+61 3 9902 0873
Fax 14021 0
Email 14021 0
[email protected]
Contact person for scientific queries
Name 4949 0
Leah Brenann
Address 4949 0
Monash University
Clayton VIC 3800
Country 4949 0
Australia
Phone 4949 0
+61 3 9902 0873
Fax 4949 0
Email 4949 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseDoes motivational interviewing improve retention or outcome in cognitive behaviour therapy for overweight and obese adolescents?.2016https://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.