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Trial registered on ANZCTR


Registration number
ACTRN12617001288314
Ethics application status
Approved
Date submitted
1/09/2017
Date registered
6/09/2017
Date last updated
9/12/2021
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to determine the effectiveness of a healthy lifestyle program for patients with chronic low back pain who are overweight or obese.
Scientific title
In people with chronic low back pain, who have a lifestyle risk factor (overweight, poor diet, physically inactive, or smoke), does evidence-based advice and education and support to improve lifestyle risks, improve disability compared to usual care?
Secondary ID [1] 292795 0
None
Universal Trial Number (UTN)
Trial acronym
HELP (Healthy Lifestyle for Low back Pain)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 304606 0
Low Back Pain 304607 0
Condition category
Condition code
Musculoskeletal 303930 303930 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention group will receive a coordinated care intervention targeting healthy lifestyle, with two components: a) clinical intervention from a physiotherapist and dietitian; and b) referral to telephone-based health coaching for weight management (diet and exercise via the NSW Get Healthy Service), and smoking cessation (counseling by the NSW Quitline) for those participants who identify as smokers.
All intervention components are delivered with individual patients.

a) Clinical intervention - Low back pain assessment, advice and monitoring (week 0-1, 3, 6 and 12)
An experienced physiotherapist will conduct an initial 1 hour clinical assessment and provide condition specific advice and education, along with instructions about the coordinated care intervention. The advice will incorporate international guideline recommended education and reassurance, with explanation of the mechanisms by which lifestyle factors such as weight, diet, physical activity and smoking cessation can improve symptoms, and reduce health risks. Specifically, provision of advice aims to improve understanding of self-management principles for low back pain, reinforce the need to stay active or gradually increase activity, and avoid bed rest, and provide rationale for the importance of the telephone healthy lifestyle coaching as part of their treatment approach. Follow up appointments will be 30 minutes in length.
Patients will also see a dietitian at week 3 immediately after physiotherapy appointments for 30-45 minutes for advice and education on healthy eating and strategies to improve their diet.
Clinicians will work to support lifestyle change and address barriers to participation in the supplemental telephone services.
Patients will also be provided with printed and online materials (email of PDFs, access to a vodcast) detailing the messages provided by clinicans.

b) Telephone-based health coaching
• Weight loss, physical activity and diet coaching program – Get Healthy (week 1 to 26)
All patients will be referred to a 6-month telephone-based weight loss coaching program delivered by allied health professionals from the NSW Get Healthy Service. Calls occur bimonthly for the first 3 months (n=6) and monthly thereafter. Call duration will vary on the delivery of the content and counseling provided to the patient.
Get Healthy sessions are delivered by a range of health professionals trained in dietetics, psychology and exercise science. The coaching sessions are based on self-regulation principles, including self-monitoring, goal setting, cognitive restructuring, problem solving, and environmental management, to assist patients set goals, achieve a healthy body weight, and improve diet and physical activity and overcome barriers to making such changes. All content and advice is provided according to standardized protocols and aligns with national diet and physical activity guidelines.
Get Healthy coaches will receive low back pain-specific training to tailor content for study participants. This includes a 3 hour face to face group interactive education workshop including a power point presentation providing information on prognosis of low back pain, lifestyle associations and challenges in addressing behavior change in this group of patients. The health coaches are also provided with a paper resource that reflects the presentation information and participate in discussion addressing some case studies of patients with low back pain seeking lifestyle change support.

• Smoking cessation program - Quitline (week 12)
Participants who smoke, will be referred to the NSW Quitline. Quitline counselors (advisors) who are trained in smoking cessation, will contact participants, and systematically record information on smoking history and previous quit attempts. Advisors encourage smokers to set a quit date, and assist in maximizing success of quitting by guiding participants through evidence-based cessation methods with consideration of individual preferences and past history of quitting. Advisors also assist callers to deal with issues such as withdrawal symptoms. After the initial contact, and establishment of a quit date, participants will be phoned on the following occasions for support: the day before the agreed quit date; within the first two days after the quit date; within the first week of the quit date; twice within the following three weeks; three months after the quit date.
Duration of the phone sessions vary depending on the patients needs and counseling provided.

Adherence to the intervention will be collected from the telephone services themselves at 6 months (regarding number of calls completed) and adherence to the consultations will be tracked throughout weeks 1-12 by the intervention physiotherapists and research team.
Intervention code [1] 299039 0
Lifestyle
Intervention code [2] 299040 0
Behaviour
Comparator / control treatment
Patients allocated to the control group will receive usual care management via a hospital physiotherapy department. This may include up to three clinical appointments. No systematic process for the provision of weight loss management or smoking cessation care to patients currently exists within the study hospital. Patients may receive care from their GP/surgeon, or access care independent to this trial. Receipt of any care outside of this trial will be measured at each follow up.
Control group
Active

Outcomes
Primary outcome [1] 303271 0
The primary outcome will be disability measured on the Roland Morris Disability Questionnaire - a 24 item low back pain specific survey, which has been validated and is a recommended core outcome for trials in low back pain.
Timepoint [1] 303271 0
Baseline, Week 6, 12, 26 and 52 (Primary endpoint is 6 months (26 weeks) post-randomisation)
Secondary outcome [1] 338487 0
Anthropometric data - weight change (kg), BMI, (using ISAK protocols)
Timepoint [1] 338487 0
Baseline, Week 6, 12, 26 and 52. (self reported)
Baseline, Week 6, week 12 (objective)
Secondary outcome [2] 338488 0
Quality of life (SF12v2)
Timepoint [2] 338488 0
Baseline, Week 6, 12, 26 and 52.
Secondary outcome [3] 338489 0
Pain self-efficacy (Pain self-efficacy Questionnaire 2)
Timepoint [3] 338489 0
Baseline, Week 6, 12, 26 and 52.
Secondary outcome [4] 338492 0
Smoking abstinence (NSW Health Survey)
Timepoint [4] 338492 0
Baseline, Week 6, 12, 26 and 52
Secondary outcome [5] 338493 0
Psychological distress (Kessler 6)
Timepoint [5] 338493 0
Baseline, Week 6, 12, 26 and 52
Secondary outcome [6] 338494 0
Physical activity behaviours (International Physical activity Questionnaire)
Timepoint [6] 338494 0
Baseline, Week 6, 12, 26 and 52 .
Secondary outcome [7] 338495 0
Alcohol consumption (AUDITC)
Timepoint [7] 338495 0
Timepoint: Baseline, Week 6, 12, 26 and 52
Secondary outcome [8] 338496 0
Nutrition (Short form food frequency questionnaire)
Timepoint [8] 338496 0
Basline, weeks 6,12,26 and 52
Secondary outcome [9] 338497 0
Intervention delivery cost data
Timepoint [9] 338497 0
6 months
Secondary outcome [10] 338555 0
Health Care utilization: Self reported and extracted from Medical records
Timepoint [10] 338555 0
Baseline, week 6, 12, 26, 52
Secondary outcome [11] 338556 0
Medication use for back pain: Self reported and extracted from Medical records
Timepoint [11] 338556 0
Baseline week 6, 12, 26, 52
Secondary outcome [12] 338557 0
Telephone–based program costs: obtained from the telephone services, Get Healthy Service and Quit line
Timepoint [12] 338557 0
6 months
Secondary outcome [13] 338558 0
Quality adjusted life years (QALY’s) (SF6D)
Timepoint [13] 338558 0
6 months and 12 months
Secondary outcome [14] 338559 0
Work absenteeism and presenteeism (self reported)
Timepoint [14] 338559 0
Baseline, Weeks 6, 12, 26 and 52
Secondary outcome [15] 354912 0
Pain (NRS 0-10)
Timepoint [15] 354912 0
Baseline, Weeks 6, 12, 26 and 52

Eligibility
Key inclusion criteria
Eligible patients will be: 18 years of age or older with chronic low back pain, defined as pain between the 12th rib and buttock crease, with or without leg pain of more than 3 months duration; Pain greater or equal to 3 on the Numerical Rating Scale or Moderate interference with daily activities of living (adapted from question in SF36).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they: are unable to use a telephone; do not live independently (i.e. require care for activities of daily living); are currently undertaking weight management or smoking cessation programs; have planned surgery in the next 6 months; are pregnant or planning pregnancy at the time of enrolment, or have a comorbidity that precludes understanding or participation in study procedures

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)
Eligible consenting patients will be randomly allocated to the intervention or control group (1:1) after baseline assessment over the phone. Randomisation will be not be disclosed to patients. Patients will be advised that they will be scheduled for an appointment with a physiotherapist (without disclosing information that there are specific physiotherapists who will deliver the intervention and usual care). All patients will fill in a written consent form to say they have read the information letter and understand and consent to participate in the program. Patients will also be asked to consent to their information being collected from any services they may be referred to as part of their care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised using a central randomisation service to ensure concealment of treatment allocation. A permuted block randomization approach will be used so that the distribution of overweight and obesity across treatment conditions (intervention or control) will be maintained regardless of their prevalence in the final sample size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using the method of Twisk for mixed models. With 3 repeated observations, an estimated intra-cluster correlation (correlation between the observations) of 0.5, alpha set at 5%, and allowing for up to 18% non-compliance, we require 346 patients to have an 80% power to detect between group differences of 3 points on Roland Morris Disability Questionnaire (SD 5) at 6 months. This is the smallest worthwhile effect that would justify implementation of the intervention. In these calculations we have conservatively ignored the increase in statistical power conferred by baseline covariates and stratification.

For the primary outcome, a P value of <0.05 will be considered statistically significant. while for the key secondary outcomes a P value of <0.025 will be considered significant. 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. 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.
Mediation analysis will be undertaken to investigate the mechanisms underlying the intervention using causal mediation analysis. We will assess the mediating effect of physical activity, diet, pain self-efficacy, pain self-efficacy and symptoms of psychological distress on low back pain disability.

Three economic analyses will also be conducted. First, a cost model will be prepared comparing the costs associated with the control and intervention pathways. Second, a cost-utility analysis conducted from the perspective of the health sector. Third, a cost-utility analysis from a societal perspective in which the additional costs (and cost savings) associated with use of community services will be conducted. Intervention costs along with costs of other health care services will be factored in with levels of utilisation to estimate the costs of healthcare use for participants. Other health care services will be valued at standard rates published by the Australian Government. Private non-medical healthcare services will be valued at standard rates published by the relevant professional body or a third party payer. Costs of community services will be based on the self-reported costs to participants. Health state utilities, required to estimate quality-adjusted life-years, will be based on measures obtained from the SF-12 and transformed into health state utilities via the SF-6D algorithm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2017
Actual
8/09/2017
Date of last participant enrolment
Anticipated
24/09/2019
Actual
7/11/2019
Date of last data collection
Anticipated
31/12/2020
Actual
30/11/2020
Sample size
Target
346
Accrual to date
Final
346
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8939 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 17310 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 297427 0
Government body
Name [1] 297427 0
National Health and Medical Research Council
Country [1] 297427 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked bag 10, Longworth Ave Wallsend, 2287 NSW
Country
Australia
Secondary sponsor category [1] 296423 0
None
Name [1] 296423 0
Address [1] 296423 0
Country [1] 296423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298536 0
Hunter New England Health Research and Ethics Committee
Ethics committee address [1] 298536 0
Ethics committee country [1] 298536 0
Australia
Date submitted for ethics approval [1] 298536 0
31/01/2017
Approval date [1] 298536 0
21/03/2017
Ethics approval number [1] 298536 0
17/02/15/4.05
Ethics committee name [2] 298537 0
University of Newcastle Ethics
Ethics committee address [2] 298537 0
Ethics committee country [2] 298537 0
Australia
Date submitted for ethics approval [2] 298537 0
01/07/2017
Approval date [2] 298537 0
12/07/2017
Ethics approval number [2] 298537 0
H-2017-0222

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

Contacts
Principal investigator
Name 77382 0
Dr Christopher Williams
Address 77382 0
Hunter New England Population Health, Locked bag 10, Booth Building, Longworth Ave Wallsend, 2287 NSW
Country 77382 0
Australia
Phone 77382 0
+61 2 49246374
Fax 77382 0
Email 77382 0
Christopher.Williams1@health.nsw.gov.au
Contact person for public queries
Name 77383 0
Emma Robson
Address 77383 0
Hunter New England Population Health, Locked bag 10, Booth Building, Longworth Ave Wallsend, 2287 NSW
Country 77383 0
Australia
Phone 77383 0
+61 2 49246206
Fax 77383 0
Email 77383 0
emma.robson@health.nsw.gov.au
Contact person for scientific queries
Name 77384 0
Emma Robson
Address 77384 0
Hunter New England Population Health, Locked bag 10, Booth Building, Longworth Ave Wallsend, 2287 NSW
Country 77384 0
Australia
Phone 77384 0
+61 2 49246206
Fax 77384 0
Email 77384 0
emma.robson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data, de-identified data
When will data be available (start and end dates)?
Proposals for data use may be submitted to the Principle investigator 12 months following publication of results.
Available to whom?
De-identified data with accompanying data dictionaries will be made available on request. All analysis protocols will be made publicly available and published in open access peer reviewed journals.
Available for what types of analyses?
Approved on request.
How or where can data be obtained?
By request via email to Principle Investigator. Christopher.Williams1@health.nsw.gov.au


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
EmbaseHealthy Lifestyle Program (HeLP) for low back pain: Protocol for a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2019-029290
EmbaseEffectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial.2021https://dx.doi.org/10.1186/s13063-021-05591-0
N.B. These documents automatically identified may not have been verified by the study sponsor.