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Trial registered on ANZCTR


Registration number
ACTRN12615000478516
Ethics application status
Approved
Date submitted
4/05/2015
Date registered
14/05/2015
Date last updated
24/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a telephone-based weight management program in overweight or obese patients with lower back pain waiting for orthopedic consultation.
Scientific title
In overweight or obese patients with lower back pain, who are waiting for consultation with an orthopedic surgeon, does a telephone-based weight management program, result in decreased patient pain, compared to usual patient care.
Secondary ID [1] 286633 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 294955 0
Overweight and obesity 294956 0
Condition category
Condition code
Musculoskeletal 295213 295213 0 0
Other muscular and skeletal disorders
Diet and Nutrition 295214 295214 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be assessed and provided advice/education by a trained physiotherapist and undertake a telephone-based healthy lifestyle coaching program, the ‘Get Healthy Service’ (GHS). The GHS involves 10 individually tailored coaching calls delivered over a 6 month period by a qualified health professional and aims to support participants to make positive lifestyle behaviour changes regarding healthy eating, physical activity and achieving and maintaining a healthy weight.

The frequency of coaching calls is individually tailored to each participant, however calls are generally provided on a tapered schedule, with a higher intensity of calls made within the first 3 months of the program. Participants also receive an information booklet that provides additional information to support them during the program to achieve their goals, a coaching journal to record goals and actions, and access to online services to help track their progress. To ensure participants are suitable for the ongoing coaching calls a number of screening and assessment questions are asked during the initial telephone call.
Intervention code [1] 291773 0
Behaviour
Intervention code [2] 291774 0
Lifestyle
Comparator / control treatment
Patients allocated to the control group will receive usual care during the 6 month trial. Control patients will receive the same brief advice as the intervention group during baseline data collection. The brief advice aims to inform patients about the importance of reducing weight or further weight gain and the link between weight and low back pain. Control patients will be monitored and data will be collected at the same time points as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 294968 0
Pain Intensity measured as the average lower back pain over the past week using a numerical rating scale of 0 to 10, where 0 is no pain and 10 is the worst possible pain
Timepoint [1] 294968 0
Baseline and at 2, 6, 10, 14, 18, 22 and 26 weeks after randomisation.
Secondary outcome [1] 314482 0
Disability and function assessed using the Roland Morris Disability Questionnaire
Timepoint [1] 314482 0
Baseline and at 6 and 26 weeks after randomisation
Secondary outcome [2] 314483 0
Patient quality of life assessed using the SF-12.v2
Timepoint [2] 314483 0
Baseline and at 6 and 26 weeks after randomisation
Secondary outcome [3] 314484 0
Diet assessed using the Food Frequency Questionnaire
Timepoint [3] 314484 0
Baseline and at 6 and 26 weeks after randomisation
Secondary outcome [4] 314485 0
Physical activity assessed using the Active Australia Survey
Timepoint [4] 314485 0
Baseline and at 6 and 26 weeks after randomisation
Secondary outcome [5] 320142 0
Weight (kg) assessed by a trained research assistant using a portable digital scale measured to the nearest 0.1kg
Timepoint [5] 320142 0
26 weeks after randomisation

Eligibility
Key inclusion criteria
*Primary complaint of pain in the lower back area (i.e. between the 12th rib and buttock crease) with or without leg pain
*Pain duration of longer than 3 months since the onset of pain
*Average back pain intensity of 3 or greater out of 10 over the past week on a numerical rating scale of 0 to 10
*Moderate level of interference in activities of daily living (adaptation of item 8 on SF36)
*Aged 18 years or over
*Classified as overweight or obese with a self-reported body mass index (BMI) between 27 or greater and less than 40
*Have access to and can use a telephone

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*A known or suspected serious pathology as the underlying cause of back pain (e.g. fracture, cancer, infection)
*A previous history of obesity surgery
*Currently participating in any prescribed, medically supervised or commercial weight loss program
*Back surgery in the last six months or planned surgery in the next 6 months
*Unable to comply with the study protocol, adapt meals or exercise, due to non-independent living arrangements
*Any medical or physical impairment apart from back pain precluding safe participation in exercise such as uncontrolled hypertension, or morbid obesity (BMI>40)
*Cannot speak and read English

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)
Potential participants have been previously contacted by Population Health as part of a cohort study. They are patients with musculoskeletal conditions, waiting for consultation with an orthopaedic surgeon at the Royal Newcastle Centre at the John Hunter Hospital, Newcastle NSW Australia.
A trained interviewer will contact patients with lower back pain and BMI between 27 and <40 via telephone for eligibility screening and baseline data collection. Eligible patients who consent to participate will be randomised to intervention or control in a 1:1 ratio, using a computer generated randomization schedule generated by an independent statistician. Following screening and (baseline) assessment, the interviewer will open an opaque envelope containing the group allocation. The participant will then be advised on the specific program details (i.e. continue as part of the cohort (control) or be referred to the health coaching service (intervention)).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated a priori by an independent statistician using SAS 9.3 through the SURVEYSELECT procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The data will be analysed by intention-to-treat and by a statistician blinded to group allocation.
Primary outcomes analysis
For pain intensity we will use linear mixed models with random intercepts for individuals to account for correlation of repeated measures (pain). The model will include terms for important prognostic factors measured prior to randomisation and specified a priori. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change in outcome from baseline to each time point between the treatment and control groups. For weight we will compare the proportional reduction in weight between groups using t-tests. We will analyse the effect of treatment separately for each outcome.
We will also conduct a sensitivity analysis of weight loss using self-report measure in a linear mixed model.
Secondary outcomes analysis
We will analyse the effect of treatment separately for each outcome using linear mixed models with random intercepts for individuals to account for correlation of repeated measures. As per primary model will include terms for important prognostic factors measured prior to randomisation and specified a priori. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change (continuous variables) or difference in proportions (dichotomous variables) in outcome from baseline to each time point between the treatment and control groups.

sample size: calculations allow for two primary outcomes. Using a standard deviation of 2.3, a two-sided alpha of 0.025 (to account for two primary outcomes) and allowing for 15% lost to follow up, a sample of 80 participants per group will, will give 90% power to detect a clinically meaningful difference of 1.5 in pain intensity between intervention and control groups. This sample also provides 80% power to detect a 5kg difference between at follow up – this accounts for 5% reduction in weight and hypothesized to be lead to a clinically meaningful reduction in pain.

Recruitment
Recruitment status
Completed
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 hospital [1] 3747 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 9627 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 291205 0
Government body
Name [1] 291205 0
Hunter New England Population Health, Hunter New England Local Health District
Address [1] 291205 0
Locked Bad 10, Wallsend, NSW 2287
Country [1] 291205 0
Australia
Funding source category [2] 291206 0
University
Name [2] 291206 0
The University of Newcastle, Faculty of Health, School of Medicine and Public Health
Address [2] 291206 0
University Drive, Callaghan, NSW 2308
Country [2] 291206 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health, Hunter New England Local Health District
Address
Locked Bad 10, Wallsend, NSW 2287
Country
Australia
Secondary sponsor category [1] 289886 0
None
Name [1] 289886 0
Nil
Address [1] 289886 0
Nil
Country [1] 289886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292772 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292772 0
Locked Bag 1
New Lambton, NSW 2305
Ethics committee country [1] 292772 0
Australia
Date submitted for ethics approval [1] 292772 0
Approval date [1] 292772 0
20/04/2015
Ethics approval number [1] 292772 0
13/12/12/5.18

Summary
Brief summary
Many patients with chronic low back pain are referred for orthopaedic surgical consultation despite most having no indication for surgical intervention. A high percentage of these patients are overweight or obese and would likely benefit from weight management care, however such care is rarely offered to these patients. Instead, patients wait for extended periods of time for consultation during which their pain symptoms and health decline. This study aims to evaluate the effectiveness of a telephone-based weight management program in decreasing weight and pain in overweight or obese patients with chronic low back pain waiting for consultation with an orthopaedic surgeon. We hypotheses that the patients who receive the telephone-based weight management program will achieve an average weight loss of 5kg and decrease their pain score by an average of 1.5 out of 10 from baseline, compared to the control group receiving usual care.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 56946 0
Dr Christopher M Williams
Address 56946 0
University of Newcastle, Locked Bag 10, Wallsend NSW 2287
Country 56946 0
Australia
Phone 56946 0
+61 2 49246102
Fax 56946 0
Email 56946 0
Christopher.M.Williams@hnehealth.nsw.gov.au
Contact person for public queries
Name 56947 0
Dr Christopher M Williams
Address 56947 0
University of Newcastle, Locked Bag 10, Wallsend NSW 2287
Country 56947 0
Australia
Phone 56947 0
+61 2 49246102
Fax 56947 0
Email 56947 0
Christopher.M.Williams@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 56948 0
Dr Christopher M Williams
Address 56948 0
University of Newcastle, Locked Bag 10, Wallsend NSW 2287
Country 56948 0
Australia
Phone 56948 0
+61 2 49246102
Fax 56948 0
Email 56948 0
Christopher.M.Williams@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary