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Trial registered on ANZCTR


Trial ID
ACTRN12613001160729
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
18/10/2013
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery from Obesity in Primary Healthcare
Scientific title
In patients with obesity, does an exercise prescription and participation in a facilitated obesity recovery network, compared to an exercise prescription alone, assist people to lose a minimum of 5% of baseline body weight?
Secondary ID [1] 283118 0
Nil
Universal Trial Number (UTN)
U1111-1147-4002
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 289966 0
Condition category
Condition code
Mental Health 290337 290337 0 0
Addiction
Diet and Nutrition 290720 290720 0 0
Obesity
Public Health 290721 290721 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287858 0
Treatment: Other
Intervention code [2] 287859 0
Lifestyle
Comparator / control treatment
The comparator group in this study is an active control group who will receive the standard treatment of a Green Prescription (GRx) alone.

Participants randomised to GRx alone will be encouraged to become involved in the exercise opportunities outlined by that prescription. Control participants will be informed that they will have the first opportunity of joining the Kia Akina network if it is shown to be effective at 12-months.
Control group
Active

Outcomes
Primary outcome [1] 290396 0
5% loss of baseline body weight based on independent assessment by GP
Timepoint [1] 290396 0
12 months after baseline
Secondary outcome [1] 304406 0
Physical fitness as measured by the 2 Minute Step in Place Test
Timepoint [1] 304406 0
6 & 12 months after baseline
Secondary outcome [2] 304407 0
Quality of life as measured by the WHOQOL-BREF
Timepoint [2] 304407 0
6 & 12 months after baseline
Secondary outcome [3] 304408 0
Mood and Anxiety as measured by the Kessler 10
Timepoint [3] 304408 0
6 &12 months after baseline
Secondary outcome [4] 304409 0
Self-esteem as measured by the Single Item Self-Esteem Scale
Timepoint [4] 304409 0
6 & 12 months after baseline
Secondary outcome [5] 304410 0
Eating compulsivity as measured by the Measure of Eating Compulsivity
Timepoint [5] 304410 0
12 months after baseline

Eligibility
Key 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
Minimum age
22 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Participants will be recruited from three General Practices in Christchurch, New Zealand. Following initial identification by the GP/nurse each participant will have their height and weight measured, will complete a physical fitness test and will have a GRx administered by the referring GP/nurse. Contact details of each recruited participant will then be relayed to a National Addiction Centre researcher who will arrange for baseline measures of well-being, psychological health and eating compulsivity to be completed on-line (although pen and paper administration will be made available for those who would prefer this). Once these baseline measures have been completed randomisation will occur.

The schedule for randomisation will be prepared by a biostastician. Application of the schedule will be undertaken by an administrative staff member of the National Addiction Centre, independently of the study investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation procedure will involve stratification for gender and primary care venue and will be arranged in permuted blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Participants will be randomly assigned on a 1:1 ratio to experimental and control groups. The primary outcome measure will be the clinically significant standard of a 5% reduction in weight. On the basis of the known natural history of traditional approaches to weight loss intervention, 5% of the control participants are expected to achieve this goal at 12 months. However, on the basis of our experience to date with the Kia Akina programme, we expect at least 25% of participants to achieve this goal. Using a two-tailed alpha of 0.05, there is 80% power to detect a difference in control and experimental participants at 5% and 25% proportions respectively who achieve the treatment goal at 12 months, with a sample size of 98 participants.

The analysis will be conducted using an intention to treat strategy, utilising the technique of “last observation carried forward” to manage data from participants who do not have 12 month observations. It is anticipated that less than 10% of participants will be non-contactable at 12 months.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5385 0
New Zealand
State/province [1] 5385 0
Canterbury

Funding & Sponsors
Funding source category [1] 287893 0
Government body
Name [1] 287893 0
Health Research Council of New Zealand
Address [1] 287893 0
PO Box 5541
Wellesley Street
Auckland 1141
Country [1] 287893 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286620 0
Other
Name [1] 286620 0
Christchurch PHO
Address [1] 286620 0
16/27 Waterman Place
Ferrymead
Christchurch 8023
Country [1] 286620 0
New Zealand
Secondary sponsor category [2] 286621 0
Other
Name [2] 286621 0
Christchurch South Health
Peak Primary Ltd
Address [2] 286621 0
PO Box 12077
Beckenham
Christchurch 8023
Country [2] 286621 0
New Zealand
Secondary sponsor category [3] 286622 0
Other
Name [3] 286622 0
Papanui Medical Centre
Address [3] 286622 0
PO Box 5049
Papanui
Christchurch 8542
Country [3] 286622 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289834 0
Health and Disability Ethics Committee
Ethics committee address [1] 289834 0
Ministry of Health
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289834 0
New Zealand
Date submitted for ethics approval [1] 289834 0
11/10/2013
Approval date [1] 289834 0
30/10/2013
Ethics approval number [1] 289834 0
Southern Health and Disability Ethics Committee 13/STH/151

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42562 0
Prof Doug Sellman
Address 42562 0
National Addiction Centre
PO Box 4345
Christchurch 8140
Country 42562 0
New Zealand
Phone 42562 0
+64 33640480
Fax 42562 0
+6433641225
Email 42562 0
doug.sellman@otago.ac.nz
Contact person for public queries
Name 42563 0
Dr Ria Schroder
Address 42563 0
National Addiction Centre
PO Box 4345
Christchurch 8140
Country 42563 0
New Zealand
Phone 42563 0
+64 33640480
Fax 42563 0
+6433641225
Email 42563 0
ria.schroder@otago.ac.nz
Contact person for scientific queries
Name 42564 0
Prof Doug Sellman
Address 42564 0
National Addiction Centre
PO Box 4345
Christchurch 8140
Country 42564 0
New Zealand
Phone 42564 0
+64 33640480
Fax 42564 0
+6433641225
Email 42564 0
doug.sellman@otago.ac.nz