Skip to content

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.

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?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001288314
Acronym
HELP (Healthy Lifestyle for Low back Pain)
Enrollment
346
Registered
2017-09-06
Start date
2017-09-08
Completion date
2019-11-07
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many patients with chronic low back pain are referred for surgical consultation without clear indications for surgical intervention. Patients often wait for extended periods for consultation during which their disability worsens and general health declines. Furthermore, a high percentage of these patients are overweight or obese and may benefit from conservative healthy lifestyle care. Unfortunately, this type of care is rarely offered to these patients. This study will test the effectiveness of a coordinated care program that includes: evidence based advice and education for low back pain, and telephone based lifestyle and weight management and smoking cessation counselling. We hypothesise that this intervention will confer a 3-point reduction in disability measured on the 0-24 point Roland Morris Disability Questionnaire, compared to usual care.

Interventions

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.

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.

Sponsors

Hunter New England Population Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026