None listed
Conditions
Brief summary
Obesity is one of the most pressing health conditions of our time, affecting nearly 30% of all New Zealand adults. There is the real threat of obesity crippling the affordability of the public health care system through the costs of associated chronic diseases, and bariatric surgery, a relatively effective intervention, yet limited in terms of numbers of patients who can be treated. The need for effective, non-surgical treatment approaches has never been greater. This research provides the opportunity to enhance much needed collaboration between specialist and primary care services and is itself an exciting new development in non-surgical approaches to obesity treatment. Utilizing a ‘food addiction’ approach to obesity, which recognises obesity as a chronic relapsing condition, this approach opens up new avenues of intervention with obese people. The focus of this study is a lifestyle change approach to obesity involving a recovery network called Kia Akina, piloting of which has shown promising results. This research will test the effectiveness of Kia Akina in obese people recruited from primary care by comparing their 12-month weight-loss outcomes with a group randomised to receive an exercise referral, called a Green Prescription, alone. If shown to be effective, Kia Akina will be developed in manageable stages as a non-commercial, low cost network for obesity recovery throughout New Zealand, strongly connected with primary care services and linked with ongoing research.
Interventions
This is a two-arm, randomised controlled trial of a GP administered Green Prescription (GRx) (a prescription given to encourage patients to access assistance to support increased activity) plus Kia Akina (a community based obesity recovery network) versus a GRx alone among people who are obese (BMI >30) (kg/m2) recruited from a routine consultation with their primary care physician. Initially this study will run for 12 months, but if the Kia Akina network is shown to be effective all participan
This is a two-arm, randomised controlled trial of a GP administered Green Prescription (GRx) (a prescription given to encourage patients to access assistance to support increased activity) plus Kia Akina (a community based obesity recovery network) versus a GRx alone among people who are obese (BMI >30) (kg/m2) recruited from a routine consultation with their primary care physician. Initially this study will run for 12 months, but if the Kia Akina network is shown to be effective all participants in the Kia Akina arm of the study will be encouraged to continue their involvement with this network and participants in the GRx alone arm will be invited to join this network. Participants in the Kia Akina arm will be encouraged to become involved in the exercise opportunities outlined by the GRx prescription and will be invited to attend at least one of two introductory Kia Akina workshops (3 hours duration), followed by any or all of the following Kia Akina components: six-monthly workshops (3 hours duration), fortnightly support groups (45-60 minutes duration), a weekly email message with ensuing discussion, a weight loss buddy system involving daily texting and daily motivational text messages. As the risks of serious adverse events occurring in this study are assessed to be low, a Data Safety Monitoring Committee is not deemed necessary for this study. Instead two forms of monitoring have been established i) A Trial Steering Committee - comprising the PI and a group of three specialist advisors - will provide overall supervision of the trial to ensure that it is being conducted in an ethically safe, and scientifically sound manner; ii) the Trial Management group comprising all of the name investigators on this study will monitor the day to day running of this study.
Sponsors
University of Otago, Christchurch
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be obese (BMI >30), 22-65 years old; wanting to lose weight; not currently involved in other weight loss programmes; and connected with their primary health care service
Exclusion criteria
People with any other current significant medical condition or undergoing medical treatment that is likely to significantly affect weight, or which makes weight loss or dietary restriction a contraindication including: a. people with uncontrolled diabetes or hypothyroidism b. severe psychiatric symptoms, including mania and psychosis, which would interfere with ability to participate in this study c. significant current risk of suicidality or homicidality d. currently being prescribed any medications that are known to significantly increase or decrease weight including oral steroids, antiobesity medications, antipsychotics and the mood-stabilising medications sodium valproate and lithium carbonate e. pregnant, lactating, trying or planning to get pregnant in the near future or refusal to use a reliable method of birth control in female participants f. insufficient intellectual or educational capacity to complete the programme based on clinical assessment, or insufficient command of the English language to participate adequately in the therapeutic programme. g. with severe physical disability impeding their ability to undertake the Two Minute Step in Place Test.
Outcome results
None listed