None listed
Conditions
Brief summary
We are conducting a clinical trial to evaluate the effectiveness of weight loss via a very low energy diet for people with chronic low back pain. We will evaluate the effectiveness of the intervention on low back pain and disability at 6 and 12 months. The control group will receive healthy eating advice from a dietitian. Primary and secondary outcomes will be collected at baseline, 6-, and 12 months post-randomisation. We hypothesise that those in the weight loss very low energy diet group will experience greater improvements in pain and disability.
Interventions
Participants in this group be offered a ketogenic Very Low Energy Diet (VLED) weight loss program prescribed by a dietitian. Participants will receive 6 individual consultations with the dietitian (over 6 months) via videocall (Zoom). The first consultation will be approximately 45 minutes in duration, with follow-up consultations approximately 30 minutes. Consultations will be recommended to occur in weeks 1, 3, 6, 10, between weeks 14-17, and between weeks 19-23. During consultations, appropri
Participants in this group be offered a ketogenic Very Low Energy Diet (VLED) weight loss program prescribed by a dietitian. Participants will receive 6 individual consultations with the dietitian (over 6 months) via videocall (Zoom). The first consultation will be approximately 45 minutes in duration, with follow-up consultations approximately 30 minutes. Consultations will be recommended to occur in weeks 1, 3, 6, 10, between weeks 14-17, and between weeks 19-23. During consultations, appropriate weight loss goals will be agreed and a tailored management plan for losing weight developed. Conversations based on motivational interviewing principles and techniques will be used to develop readiness to change (motivation) and confidence to self-manage. The VLED comprises two phases: 1) intensive weight loss using meal replacements, and 2) transition off meal replacements onto a longer-term eating plan for weight maintenance. The intensive weight loss phase involves replacing two meals with VLED meal replacement products. The third meal of the day comprises protein, non-starchy vegetables/salad, and a small amount of fat/oil. In total, the diet contains 800 calories (3,280 kilojoules). Phase 2 will commence once participants reach their individual goal weight. To transition, only one meal replacement is used per day and foods containing carbohydrates are reintroduced. After approximately four weeks of one meal replacement per day, the participant will commence a healthy eating diet which is consistent with the principles of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) total wellbeing diet (i.e. high protein, low glycaemic index carbohydrate, low fat). Participants will also be provided with additional bespoke educational and behaviour change resources (booklets specifically designed for this trial) to support their weight loss efforts.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for the trial if they meet the following inclusion criteria: i) Have chronic low back pain, defined as pain in the area between the 12th rib and buttock crease with or without accompanying leg pain; ii) Low back pain of at least 12 weeks duration; iii) Mean back pain intensity >= 4/10 on NRS in the past week; iv) Sufficient fluency in the English language to understand and respond to English language questionnaires and to engage with the interventions; v) Age 18-70, inclusive; vi) Access to a device with internet connection; vii) Self-reported BMI >27 kg/m^2; based on the Royal Australian College of General Practitioners guidelines for obesity management which indicates usage of a very low energy diet to induce rapid weight loss for those with BMI >27 kg/m^2 and comorbidities; viii) Willing to lose weight and use meal replacements; ix) Willing and able to give informed consent and participate in the assessment procedures.
Exclusion criteria
i) Known or suspected serious pathology causing CLBP (e.g. spinal fracture, cancer, cauda equina compression, inflammatory arthritis); ii) Spinal surgery less than 12 months previously; iii) On waiting list for/planning back/lower limb surgery or bariatric surgery in next 12 months; iv) Weight loss of > 2 kg over the previous 3 months; v) Using, or planning to use, weight loss drugs (e.g., GLP-1 receptor agonists, such as Semaglutide); vi) Unable to undertake ketogenic very low energy diet (VLED) without closer medical supervision, including self-reported: a. Type 1 diabetes b. Type 2 diabetes requiring medication apart from metformin c. stroke or cardiac event in previous 6 months d. unstable cardiovascular condition e. fluid intake restriction f. renal (kidney) problems (unless clearance is obtained from general practitioner, including general practitioner confirmation that estimated glomerular filtration rate >30 mL/min/1.73m^2) vii) Pregnancy or planned pregnancy in next 12 months, or less than 6-months postpartum or breastfeeding; viii) Vegan dietary requirements due to complexity of delivering a nutritionally complete diet within the ketogenic diet regime.
Outcome results
None listed