The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000537752
Ethics application status
Approved
Date submitted
8/05/2013
Date registered
14/05/2013
Date last updated
22/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of cognitive remediation therapy for the obese - a preliminary investigation
Scientific title
The efficacy of behavioural weight loss programme plus cognitive remediation therapy compared to behavioural weight loss programme alone on cognitive functioning, weight loss, mood, emotion regulation, habitual cluster behaviours and health literacy in obese individuals from the community
Secondary ID [1] 282474 0
None
Universal Trial Number (UTN)
U1111-1142-7870
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 289094 0
depression 289095 0
emotion regulation 289096 0
habitual cluster behaviours 289097 0
health literacy 289098 0
executive function 289099 0
Condition category
Condition code
Diet and Nutrition 289437 289437 0 0
Obesity
Mental Health 289466 289466 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is one intervention group that will undergo both the Behaviour Weight Loss Programme (BWL) and Cognitive Remediation Therapy (CRT). For this group, the Cognitive Remediation Therapy will run immediately after completion of BWL. The Behavioural Weight Loss Programme will be run in a group format (small group sessions of 6 to 8 people) by a Clinical Psychologist, once weekly, 90 minutes for 3 consecutive weeks. The BWL program in this study targets diet and exercise through behavioural modification techniques. Participants receive comprehensive education about nutrition. Problem solving techniques are taught so that participants can effectively deal with difficult situations that threaten their weight control efforts. Toward the end of treatment, attention is given to motivation enhancement and relapse prevention to help individuals maintain their weight loss. A record of attendance will be kept to monitor adherence.

CRTwill be run on a individual basis by a Clinical Psychologist who has had special training in CRT. The CRT sessions will be conducted twice weekly for four weeks (a total of 8 sessions) each session lasting for approximately an hour. A record of attendance will be kept to monitor attendance. Cognitive exercises in the form of puzzles, games, memory tasks will form the content of CRT, where the focus is not on performance per se but learning and reflection. Homework tasks will be provided in between sessions to facilitate generalization of skills gained in therapy.



Intervention code [1] 287123 0
Treatment: Other
Intervention code [2] 287142 0
Behaviour
Comparator / control treatment
Behavioural Weight Loss (BWL) Program:Three 90 minutes weekly sessions of a group Behavioural Weight Loss (BWL) program, administered to small groups of 6 to 8 people by a Clinical Psychologist. At the end of the third session, half the group will be randomized to enter CRT. Those participants who do not enter CRT will be the control group.
Control group
Active

Outcomes
Primary outcome [1] 289540 0
Cognitive Functioning. Outcome assessed through a neuro-psychological test battery comprising of (a) Rey Complex Figure Test (b) Trail Making Task (c) Wisconsin Card Sorting Task (d) National Adult Reading Test (e) Reward Loss Task (f) BRIEF A and (g) Digit Span subtest of WAIS III
Timepoint [1] 289540 0
Immediately post completion of all CRT sessions (8 sessions in total)
Primary outcome [2] 289541 0
weight loss- assessed by digital scales
Timepoint [2] 289541 0
90 days post CRT
Secondary outcome [1] 302701 0
Depression assessed by the psychometric inventory DASS 21
Timepoint [1] 302701 0
90 days post CRT
Secondary outcome [2] 302702 0
Emotion regulation- assessed by the psychometric inventory DERS
Timepoint [2] 302702 0
90 days post CRT
Secondary outcome [3] 302703 0
Health Literacy- assessed by- Modified version of the Bulimia Mental Health Literacy Questionnaire
Timepoint [3] 302703 0
90 days post CRT
Secondary outcome [4] 302704 0
Habitual Cluster Behaviours- assessed by the (modified) Self-Report Habit Index (SRHI);
Timepoint [4] 302704 0
90 days post CRT

Eligibility
Key inclusion criteria
Inclusion criteria for this group are: having a BMI > 30, age 18- 55 years, current weight under 180 kgs, ability to consent and having completed 10 years of education in English. Participants who are depressed and wish to take part of the trial will be included. Patients with hypertension (medicated or not medicated), type 2 diabetes, or high cholesterol will be included. Those with binge eating disorder will not be excluded. We aim for equal number of females and males, but based on past weight loss studies, ~60% will be females.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a history of psychosis, head injury, neurological disorder including degenerative or inflammatory conditions or stroke, ADHD, epilepsy, developmental or intellectual disability, are unable to complete the testing (e.g. due to hearing, vision or language impediment), are on regular sedative or stimulant medication, and/or if they report substance (alcohol or other) regular use/abuse (more than 2 standard drinks 5 times a week). Individuals will also be excluded if they have regular use of sedatives, hypnotics, antipsychotics, anti-cholinergic or cholinergic medications.

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)
Participants: 90 obese individuals (BMI: kg/m2 >= 30) will be recruited from the community. Participants will be recruited via direct advertisement to the community. After establishing that a person meets all eligibility criteria (via a phone interview), a clinical assessment will be conducted to exclude co-morbidities and to collect baseline measures. The participant will then be allocated to three 90 minutes weekly sessions of a group Behavioural Weight Loss (BWL) program. Participants in this group will be referred to their G.P., community health centre or a local psychologist if emotional duress or a mental illness is evident. At the end of the BWL programme, half the participants will be randomized to a CRT individual programme conducted twice weekly for 4 weeks. The other half will not receive further treatment. Allocation concealment was achieved by using the web randomization programme called Sealedenvelope.com.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to a treatment condition following a blind randomisation procedure (according to CONSORT- Moher et al., 2011). The treatment condition for each individual will be predetermined by the use of an external web-based randomization program, called Sealed Envelope (www.sealedenvelope.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analytic Strategies: Data will be inspected for normality and non-parametric statistic applied where appropriate. Sample of 90 or 45 per group is based on power estimates using Cohen’s tables for an effect size of 0.6, power of 0.8, 2-tailed test p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6870 0
2077 - Hornsby
Recruitment postcode(s) [2] 6871 0
2031 - Randwick
Recruitment postcode(s) [3] 6872 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 287253 0
University
Name [1] 287253 0
University of Western Sydney
Address [1] 287253 0
School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country [1] 287253 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 286005 0
University
Name [1] 286005 0
University of New South Wales
Address [1] 286005 0
School of Psychiatry
34 Botany Street,
University of New South Wales,
Randwick NSW 2031
Country [1] 286005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289233 0
University of WEstern Sydney Human Ethics
Ethics committee address [1] 289233 0
Jill Shute
Office of Research Services
Kingswood Campus, Building K
Locked Bag 1797
Penrith NSW 2751
Australia
Ethics committee country [1] 289233 0
Australia
Date submitted for ethics approval [1] 289233 0
Approval date [1] 289233 0
23/10/2012
Ethics approval number [1] 289233 0
H9787

Summary
Brief summary
Obese individuals are known to suffer from significant cognitive deficits, especially in the area of executive function, leading to poor planning, impulse control and decision making deficits. Research in this field has identified a point at which an intervention could interrupt this vicious cycle. This project aims to examine the relationship between cognition and obesity through a randomized controlled trial (RCT) testing the efficacy of a novel cognitive remediation therapy (CRT) in obese individuals to reduce these deficits and aid weight loss maintenance
Trial website
Trial related presentations / publications
Jayanthi Raman, Evelyn Smith, and Phillipa Hay, “The Clinical Obesity Maintenance Model: An Integration of Psychological Constructs including Mood, Emotional Regulation, Disordered Overeating, Habitual Cluster Behaviours, Health Literacy and Cognitive Function,” Journal of Obesity, vol. 2013, Article ID 240128, 9 pages, 2013. doi:10.1155/2013/240128
Public notes

Contacts
Principal investigator
Name 39906 0
Ms Jayanthi Raman
Address 39906 0
University of Western Sydney, School of Medicine, Locked Bag 1797, Penrith, NSW 2751.
Country 39906 0
Australia
Phone 39906 0
+61408422850
Fax 39906 0
Email 39906 0
js2009au@gmail.com
Contact person for public queries
Name 39907 0
Ms Jayanthi Raman
Address 39907 0
University of Western Sydney, School of Medicine, Locked Bag 1797, Penrith, NSW 2751.
Country 39907 0
Australia
Phone 39907 0
+61408422850
Fax 39907 0
Email 39907 0
js2009au@gmail.com
Contact person for scientific queries
Name 39908 0
Ms Jayanthi Raman
Address 39908 0
University of Western Sydney, School of Medicine, Locked Bag 1797, Penrith, NSW 2751.
Country 39908 0
Australia
Phone 39908 0
+61408422850
Fax 39908 0
Email 39908 0
js2009au@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results