Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000163808
Ethics application status
Not yet submitted
Date submitted
2/02/2012
Date registered
6/02/2012
Date last updated
7/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective pilot study evaluating the effects of a clinically-supervised weight loss intervention programme combined with behavioural change strategy in morbidly obese adults in Singapore
Scientific title
A prospective pilot study evaluating the effects of a clinically-supervised weight loss intervention programme combined with behavioural change strategy in morbidly obese adults in Singapore
Secondary ID [1] 279858 0
Nil
Universal Trial Number (UTN)
U1111-1127-9001
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 285743 0
Condition category
Condition code
Public Health 285931 285931 0 0
Health service research
Diet and Nutrition 285954 285954 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 24-week clinically supervised standardised weight management programme combined with additional weekly 24-week follow up standardised telephone counselling.

Both groups will be provided with a standardised clinically supervised weight management programme over a 24 week period. The programme will consist of:
a) 1 Doctor Consultation (Individual)
b) 1 Doctor Consultation follow up (Group of 10)
c) 2 Dietitian Consultations (Individual)
d) 2 Dietitian Educational Talks on Nutrition (Group of 15)
e) 1 Supermarket Tour for Healthier Food Choices conducted by the Dietitian (Group of 15)
f) 2 Physiotherapy Fitness Assessments (Baseline and Final)
g) 4 Supervised Exercise Sessions at LIFE Centre by Physiotherapists
h) A 1-year Home Walking programme. Participants will have to clock and record a weekly average of 70,000 steps throughout the programme and maintain this intensity for a further 24 weeks after the programme is completed.

Each of the above sessions will last approximately an hour.

The telephone counselling will be administered to the experimental group at the end of the programme.

It consists of a standardised script-based interaction for 15-30mins once per week with questions pertaining to 3 domains: Physical Activity, Nutrition: Calorie Intake, and Mental Health: Subjective recording of their feelings followed by reminders to continue the exercise programme on their own and words of encouragement,
Intervention code [1] 284176 0
Lifestyle
Intervention code [2] 284177 0
Behaviour
Intervention code [3] 284178 0
Treatment: Other
Comparator / control treatment
A 24-week clinically supervised standardised weight management programme.
Control group
Active

Outcomes
Primary outcome [1] 286419 0
BMI - Using the Tanita Body Composition Analyser
Timepoint [1] 286419 0
Baseline, 24th and 48th week from commencement
Primary outcome [2] 286420 0
Body Fat % - Using the Tanita Body Composition Analyser
Timepoint [2] 286420 0
Baseline, 24th and 48th week from commencement
Primary outcome [3] 286421 0
Waist-Hip Ratio - Use of a simple tape measure to measure the waist and hip circumference 1cm below the navel and at the greater hip trochanter respectively.
Timepoint [3] 286421 0
Baseline, 24th and 48th week from commencement
Secondary outcome [1] 295820 0
Systolic and Diastolic blood pressure - using an automated blood pressure monitor
Timepoint [1] 295820 0
Baseline, 24th and 48th week from commencement
Secondary outcome [2] 295821 0
Health Risk Assessment questionaire
Timepoint [2] 295821 0
Baseline, 24th and 48th week from commencement
Secondary outcome [3] 295822 0
SF-36 - the score for the Physical Health domain as rated on the physical functioning, role-physical, and bodily pain scale.
Timepoint [3] 295822 0
Baseline, 24th and 48th week from commencement
Secondary outcome [4] 295823 0
Visual Analogue Scale (VAS) - Pain score
Timepoint [4] 295823 0
Baseline, 24th and 48th week from commencement
Secondary outcome [5] 295824 0
Baecke Questionaire - Indices (Work, Sports and Leisure) for measurement of habitual physical activity
Timepoint [5] 295824 0
Baseline, 24th and 48th week from commencement
Secondary outcome [6] 295825 0
Binge Eating Scale
Timepoint [6] 295825 0
Baseline and 24th week from commencement
Secondary outcome [7] 295826 0
Motivation Interviewing Readiness Ruler
Timepoint [7] 295826 0
Baseline and 24th week from commencement
Secondary outcome [8] 295827 0
Beck Depression Inventory
Timepoint [8] 295827 0
Baseline and 24th week from commencement
Secondary outcome [9] 295828 0
Non-Exercise Fitness Test (NEFT)
Timepoint [9] 295828 0
Baseline, 24th and 48th week from commencement
Secondary outcome [10] 295829 0
Blood test - Fasting Blood Glucose, Cholesterol, Creatinine, Urine ACR, ALT, AST
Timepoint [10] 295829 0
Baseline and 24th week from commencement

Eligibility
Key inclusion criteria
a) Participants between 20 and 65 years of age.
b) BMI greater than or equals to 37.5 kg/m2 WITH at least 1 of the following obesity-associated co-morbidities:
i.Type 2 Diabetes Mellitus
ii. Hypertension
iii. Dyslipidemia
iv.Severe osteoarthritis of the knees, hips and lumbar spine
c) Each participant must be in the care of a primary care physician who is managing their chronic medical conditions.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Those with a coronary event (myocardial infarction, heart failure, revascularization procedure) in the last 6 months prior to commencement of programme.
b) Those with a hospital admission in the last 3 months prior to commencement of programme.
c) Uncontrolled psychiatric disorders, including eating disorders, psychosis and depression.
d) Female participants who are pregnant.
e) Those who are unable to participate in moderately intensive physical activity due to medical conditions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective participants who meet the inclusion and exclusion crteria will be referred from Health Promotion Board, Singapore to the clinically supervised weight loss programme.

All prospective participants, with their demographic information detailed, will undergo a baseline assessment of the primary and secondary outcome measures. The outcome measures will be retaken following the completion of the 24-week standardised weight management programme. Subsequently, only prospective participants who have either maintained or have lost weight from their baseline initial assessment will be block-randomised to either the control or treatment group. The randomization sequence will be concealed with opaque envelopes. Study participants will be randomly assigned a specifc allocation number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4100 0
Singapore
State/province [1] 4100 0
Singapore

Funding & Sponsors
Funding source category [1] 284631 0
Government body
Name [1] 284631 0
Health Promotion Board
Country [1] 284631 0
Singapore
Primary sponsor type
Individual
Name
Hanniel Han Rong LIM
Address
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country
Singapore
Secondary sponsor category [1] 283544 0
Hospital
Name [1] 283544 0
Singapore General Hospital Pte Ltd
Address [1] 283544 0
Outram Road
Singapore 169608
Country [1] 283544 0
Singapore

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286624 0
Singhealth Centralised Institutional Review Board
Ethics committee address [1] 286624 0
Singapore Health Services Pte Ltd
7 Hospital Drive, Block A, #03-01
SingHealth Research Facilities
Singapore 169611
Ethics committee country [1] 286624 0
Singapore
Date submitted for ethics approval [1] 286624 0
16/12/2011
Approval date [1] 286624 0
Ethics approval number [1] 286624 0

Summary
Brief summary
This research study aims to evaluate the effectiveness of telephone counselling in conjunction with a weight management programme on weight loss and compliance. We hypothesize that weekly telephone counselling in addition to a standard weight management programme will result in a greater percentage of weight loss and increase in compliance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33723 0
Address 33723 0
Country 33723 0
Phone 33723 0
Fax 33723 0
Email 33723 0
Contact person for public queries
Name 16970 0
Hanniel Han Rong LIM
Address 16970 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country 16970 0
Singapore
Phone 16970 0
+6563266802
Fax 16970 0
Email 16970 0
hanniel.lim.h.r@sgh.com.sg
Contact person for scientific queries
Name 7898 0
Hanniel Han Rong LIM
Address 7898 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country 7898 0
Singapore
Phone 7898 0
+6563266802
Fax 7898 0
Email 7898 0
hanniel.lim.h.r@sgh.com.sg

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

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