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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low back pain

Overweight and obesity

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Diet and Nutrition

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]

Behaviour

Intervention code [2]

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]

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]

Baseline and at 2, 6, 10, 14, 18, 22 and 26 weeks after randomisation.

Secondary outcome [1]

Disability and function assessed using the Roland Morris Disability Questionnaire

Timepoint [1]

Baseline and at 6 and 26 weeks after randomisation

Secondary outcome [2]

Patient quality of life assessed using the SF-12.v2

Timepoint [2]

Baseline and at 6 and 26 weeks after randomisation

Secondary outcome [3]

Diet assessed using the Food Frequency Questionnaire

Timepoint [3]

Baseline and at 6 and 26 weeks after randomisation

Secondary outcome [4]

Physical activity assessed using the Active Australia Survey

Timepoint [4]

Baseline and at 6 and 26 weeks after randomisation

Secondary outcome [5]

Weight (kg) assessed by a trained research assistant using a portable digital scale measured to the nearest 0.1kg

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/05/2015

Actual

18/05/2015

Date of last participant enrolment

Anticipated

2/11/2015

Actual

27/10/2015

Date of last data collection

Anticipated

Actual

24/05/2016

Sample size

Target

160

Accrual to date

Final

160

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton Heights

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Population Health, Hunter New England Local Health District

Address [1]

Locked Bad 10, Wallsend, NSW 2287

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Newcastle, Faculty of Health, School of Medicine and Public Health

Address [2]

University Drive, Callaghan, NSW 2308

Country [2]

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]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1
New Lambton, NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/04/2015

Ethics approval number [1]

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

Dr Christopher M Williams

Address

University of Newcastle, Locked Bag 10, Wallsend NSW 2287

Country

Australia

Phone

+61 2 49246102

Fax

Christopher.M.Williams@hnehealth.nsw.gov.au

Contact person for public queries

Name

Christopher M Williams

Address

University of Newcastle, Locked Bag 10, Wallsend NSW 2287

Country

Australia

Phone

+61 2 49246102

Fax

Christopher.M.Williams@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Christopher M Williams

Address

University of Newcastle, Locked Bag 10, Wallsend NSW 2287

Country

Australia

Phone

+61 2 49246102

Fax

Christopher.M.Williams@hnehealth.nsw.gov.au

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	A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: Study protocol Rehabilitation, physical therapy and occupational health.	2016	https://dx.doi.org/10.1186/s12891-016-0922-1
Embase	Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: Protocol for a causal mediation analysis.	2017	https://dx.doi.org/10.1136/bmjopen-2016-014652
Embase	Economic evaluation of a healthy lifestyle intervention for chronic low back pain: A randomized controlled trial.	2019	https://dx.doi.org/10.1002/ejp.1334
Embase	Compliance with telephone-based lifestyle weight loss programs improves low back pain but not knee pain outcomes: Complier average causal effects analyses of 2 randomised trials.	2022	https://dx.doi.org/10.1097/j.pain.0000000000002506

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically