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Trial registered on ANZCTR


Registration number
ACTRN12625000097448
Ethics application status
Approved
Date submitted
19/12/2024
Date registered
29/01/2025
Date last updated
29/01/2025
Date data sharing statement initially provided
29/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a healthy food guidance programme plus an exercise therapy programme improve outcomes for people with hip and knee osteoarthritis and at least one other chronic condition?
Scientific title
He Oranga mo te Whanau: a cluster randomised pragmatic clinical implementation trial of the Management of Osteoarthritis (MOA) and the Prediabetes Intervention Package (PIP) for people with hip and knee osteoarthritis and co-morbidities
Secondary ID [1] 313593 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12623001330639 - Pilot study

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 336126 0
knee osteoarthritis 336127 0
Prediabetes 336128 0
Diabetes 336129 0
Heart failure 336130 0
Coronary heart disease 336131 0
Hypertension 336132 0
Chronic obstructive pulmonary disease (COPD) 336133 0
Depression - mild to moderate 336134 0
other comorbid chronic non-communicable diseases / long-term conditions 336135 0
Condition category
Condition code
Musculoskeletal 332677 332677 0 0
Osteoarthritis
Metabolic and Endocrine 332678 332678 0 0
Diabetes
Metabolic and Endocrine 332679 332679 0 0
Other metabolic disorders
Cardiovascular 332680 332680 0 0
Hypertension
Cardiovascular 332681 332681 0 0
Coronary heart disease
Cardiovascular 332682 332682 0 0
Other cardiovascular diseases
Respiratory 332683 332683 0 0
Chronic obstructive pulmonary disease
Mental Health 332684 332684 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will have two main components - a healthy food choices guidance programme and an exercise therapy and basic patient education programme.

HEALTHY FOOD GUIDANCE and SUPPORT - THE PIP PROGRAMME
This intervention will be delivered by trained primary care nurses and health coaches in the general practice setting. The purpose of the intervention is to deliver consistent evidence-based dietary messages to participants by their primary health care team. The focus of the intervention is to provide participants (and their family/whanau) with an understanding of the principles of healthy eating, so they are empowered and able to make good food choices. That is, the dietary guidance and support will not be prescriptive. The pragmatic intervention package, designed and trialed previously in collaboration with primary care providers has five main components:
1. Health Professional Training and Support
Primary care nurses and health coaches will undertake an intensive half-day training course on brief dietary assessment and guidance, and osteoarthritis. The specific topics will include dietary assessments in the primary care setting using a New Zealand modified version of 'Starting the Conversation': Diet, internal and external factors affecting food choices, culture, behaviour change, goal setting and effective communication of dietary information, and contemporary osteoarthritis patient education from www.freefromkneepain.org. The course will be delivered by study investigators. A training manual will provide reference material, as well as research protocols. A 2-hour update course will be run at 6-months.
A research nurse will visit participating practices monthly to review intervention delivery processes and to provide support and advice, as needed, in order to maximise intervention fidelity. Fidelity will be reviewed at monthly practice visits.
All participating primary care nurses will be instructed on standard practices for measuring anthropometry and blood pressure. Practice equipment will be calibrated.
2. Individual Patient Education
All eligible participants will be offered an initial 30 minute individual dietary session with the primary care nurse. They will be asked to complete a brief dietary assessment (Starting the Conversation:Diet modified to the New Zealand context.) at their first appointment. They will be encouraged to bring family/whanau to the session. Two to three goals will be determined and they will be given individualised dietary advice tailored to their situation based on a set of structured questions and the brief dietary assessment. They will be provided with appropriate written resources. Fifteen minute follow-up sessions will be delivered by health coaches or practice nurses at 1-2 weeks, 5-6 weeks, 3 months, 4 months and 6 months. Ongoing follow-up will be provided at 3-monthly intervals for a ‘weigh-in’ and to provide brief targeted dietary advice and support.
If a participant has a healthy weight, and good dietary habits, then they may not complete all six visits. This will be at the discretion of the primary care nurse or health coach following the first appointment.
3. Goal Setting & Key Messages
Two to three individually tailored dietary goals determined between the primary care nurse and patient (based on the structured questions and brief dietary assessment) will be incorporated into the general practice patient management systems (PMS). These messages will facilitate opportunistic targeted advice and guidance by GPs, thus reinforcing information provided at primary care nurse dietary consultations. The goals/messages will be reviewed and updated accordingly at the follow up appointments.
4. Nutritionally supportive primary care environment
The dietary information provided in pamphlets, magazines and posters in participating general practice waiting rooms will be reviewed, and updated so that consistent appropriate dietary messages are reinforced within the primary care environment.
5. Written Resources
The main written patient resource used will the Diabetes New Zealand “Diabetes and healthy food choices” pamphlet.

EXERCISE THERAPY PROGRAMME with patient education
The exercise therapy programme will commence after the second PIP visit and will take place concurrently with the remaining PIP intervention visits thereafter.

The exercise programme consists of twelve 50-60 minute exercise therapy sessions with a trained physiotherapist. The first session will be individual (one-to-one); subsequent visits may be individual (one-to-one) or supervised group exercise therapy, depending on each participant’s preference. The sessions will take place at either a community physiotherapy clinic or, in the case of group sessions, at a community location, such as a community hall, sport venue or public park.

The exercise therapy protocols include land-based functional strength and neuromuscular coordination exercises, which have been specifically designed to use minimal equipment, be readily delivered in outpatient or primary care settings and transferable to group and home use. The exercise therapy programme was co-designed with the physiotherapists who are going to deliver the programme. This occurred during 3 development/training sessions (of 3-4 hours duration) with input from a Maori community exercise consultant. The development was based on existing evidence-based interventions, principally the Management of Osteoarthritis (MOA) and GLA:D (gladinternational.org), which were adapted for the local context and population for this study.

At the beginning of the programme, each participant will be given a booklet describing the programme principles and each exercise (a warm-up section with four different options plus seven exercise sections or stations). Each exercise has 4 levels of difficulty, along with tips on how to make each level a little more, or a little less, challenging.

During the programme, patient education and resources will be delivered, using the and contemporary osteoarthritis patient education from www.freefromkneepain.org, including: 'Hei whakamohio mo te Uruumu a-Hope - Information for people with Hip Arthritis', and 'Hei whakamohio mo te Uruumu a-Turi - Information for people with Knee Arthritis' (https://www.freefromkneepain.org/resources/print).

Each of the 12 exercise-therapy programme sessions will consist of three parts: a warm-up (3-5 minutes of any one of four options from the ‘warm-up’ section of the booklet), followed by two or more sets of each of the 7 standardised but individualised exercises. Exercises include: 1. Calf muscle strengthening; 2. Outer hip muscle strengthening; 3. Trunk muscle strengthening; 4. Knee extensor muscle strengthening, functional movements (e.g. knee extension in sitting and chair stands); 5. Lunges; 6. Backwards walking for neuromuscular coordination and muscle lengthening; and 7. Hip extensor muscle strengthening (e.g. extension in standing and ‘bridging’ pelvic lifts). Each exercise is progressed within and between levels with the intention that participants find the exercises at least moderately difficult and ideally ‘hard’ to ‘very hard’ based on the Borg rate of perceived exertion scale (i.e. between 4 and 8-or-9 on a scale from 1 to 10) whilst avoiding undue joint pain exacerbation during or following exercise sessions (pain increase to >5/10 or lasting longer than 24 hours), ideally returning to day-to-day symptoms within 24 hours. Participants will be counselled to expect some muscle soreness (explained as distinct from joint pain) that may last more than 48 hours. These principles will be explained to participants during the first one-to-one sessions with further explanations and information in the exercise booklet provided.

The 12 exercise therapy sessions will take place over one year, beginning with an initial block of nine supervised sessions over a 7 week period. This is referred to as the ‘loading dose’ with the intention of also guiding participants toward independent self-management. This will followed by two booster sessions at 6 months and one at 11 months.

Each participant’s performance of the exercises will be assessed during each supervised session, in which the physiotherapist will provide recommendations to each participant on what level to start each exercise station at – that is,. exercise difficulty will be individualised. Exercise difficultys will then be progressed or regressed based on guidance from the booklet resources and/or the supervising physiotherapist, where applicable.

Adherence to the intervention by participants will be monitored by the supervising physiotherapist verbally at each intervention session, and through assessment of each participant’s goal achievement.

Progress to self-management: All participants, whether one-to-one or group exercise, will be encouraged to continue to do exercise sessions, or their chosen form of alternative exercise, at least twice a week for the duration of the trial and beyond.
Intervention code [1] 330190 0
Treatment: Other
Comparator / control treatment
Usual medical and community care (with no restrictions or influence of the investigators).
Usual medical and community care may include any intervention routinely offered by participants' general medical practitioner, primary care practice, health service and/or health system (e.g., prescription medications for the treatment of cholesterol and/or diabetes; diabetes nurse education sessions, podiatry care, etc.), and/or any care sought and obtained by any participant, of their own volition, from any kind of provider (e.g. chiropractic, osteopath, podiatrist, etc).
No study treatment will be offered prior to crossover to the intervention condition (timing of crossover is randomly allocated - Group 1 = 3 months; Group 2 = 6 months; Group 3 = 9 months; Group 4 = 12 months in control condition before crossover to intervention)
Control group
Active

Outcomes
Primary outcome [1] 340206 0
Clinical Effectiveness: ShortMAC (WOMAC pain subscale + short version of WOMAC function subscale) at 6 month timepoint (and secondary at 1 year timepoint)
Refer to: doi: 10.2519/jospt.2018.7676 ; PMID: 29056072
Timepoint [1] 340206 0
Collected at Baseline, and 3-monthly until 1 year after crossover to intervention commencement. The primary timepoint for clinical effectiveness is 6 months after crossover.
Primary outcome [2] 340207 0
Economic Evaluation: cost-effectiveness (net cost per QALY) expressed as cost-utility ratio, incremental net monetary benefit (NMB), and cost effectiveness acceptability curve (CEAC) at willingness-to-pay thresholds of 0.5, 1, 2, and 3x GDP per capita per year, at one year timepoints
Timepoint [2] 340207 0
Collected at Baseline, 3-months, and 6-monthly until 1 year after crossover to intervention commencement. The primary timepoint for cost-effectiveness is 1 year after crossover
Secondary outcome [1] 443290 0
Global Rating of Change (GROC) in physical function
Timepoint [1] 443290 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [2] 443291 0
Global Rating of Change (GROC) in pain
Timepoint [2] 443291 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [3] 443292 0
Physical function: Timed up-and go; 30-second sit-to-stand
Timepoint [3] 443292 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [4] 443293 0
Multimorbidity Treatment Burden Questionnaire
Timepoint [4] 443293 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [5] 443294 0
Osteoarthritis Knowledge
Timepoint [5] 443294 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [6] 443295 0
Work Productivity and Activity Impairment. The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in paid or unpaid activity because of health problem during the past seven days.
Timepoint [6] 443295 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [7] 443296 0
Depression
Timepoint [7] 443296 0
Collected at Baseline, and 3-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [8] 443297 0
Physical Activity
Timepoint [8] 443297 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [9] 443298 0
Health related Quality of Life
Timepoint [9] 443298 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [10] 443299 0
Body mass index (BMI)
Timepoint [10] 443299 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [11] 443300 0
Diet
Timepoint [11] 443300 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.
Secondary outcome [12] 443301 0
resting blood pressure
Timepoint [12] 443301 0
Collected at Baseline, and 6-monthly until 1 year after crossover to intervention commencement.

Eligibility
Key inclusion criteria
A clinical diagnosis of lower limb osteoarthritis using the established National Institute for Health and Care Excellence (NICE) (www.nice.org.uk/guidance/ng226/chapter/Recommendations#diagnosis) or the American College of Rheumatology (ACR) criteria,
and at least one of the following:
- type 2 diabetes,
- pre-diabetes,
- heart failure,
- coronary heart disease (CHD),
- hypertension,
- chronic obstructive pulmonary disease (COPD),
- mild-to-moderate depression, or
- other comorbid chronic non-communicable diseases / long-term conditions
Minimum age
35 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participation in supervised systematic exercise for hip or knee osteoarthritis or a chronic condition within the last 3 months,
* Major surgery within the last 3 months.
* Pregnancy,
* An unstable health condition or at risk of serious adverse events from land-based exercise,
* Life expectancy of less than 12 months,
* Major depression or other major mental illness
* Not independently mobile in the community,
* Not willing or available to participate for the intervention duration,
* Unable to comprehend the recruitment or intervention processes (with an interpreter or assessor reading assistance provided, if required),
* Planning to move prior to completing the study treatment programme..

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)
central randomisation electronically by REDCap after consent and baseline assessment completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by region and cluster size (> 3, = 3)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Cluster randomised crossover trial, clustered by whanau (social connection unit). All participants cross over from usual care to intervention condition. Timing of crossover is randomly assigned (4 groups: 3 months; 6 months; 9 months; 12 months, in 1; 1; 1; 1 ratio). Rollout of trial by stepped wedge, beginning in South (Flaxmere), sequentially to North (Hastings, then Taradale, then Marainui, then Napier) to avoid risk of resource constraints.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis plan – see: https://osf.io/8m6kt/
Treatment effects will be estimated using linear mixed-effect models, adjusting for region, cluster size, and secular time trend (linear, by date of follow-up data collection). Clustering by individual participant and by cluster will be accounted for by cluster, cluster-by-time, and individual random effects (inducing a block exchangeable correlation structure in the random component of the model). The treatment effect of interest is a constant intervention effect (adjusted difference between pre-intervention and post-intervention outcomes); secondary analysis will estimate time-varying treatment effects (separate intervention effects for each of the 3-, 6-, 9-, and 12-month follow-up time points following the delivery of the intervention).

Power calculations have been made by repeatedly simulating data from an assumed data generating process, analysing each resultant dataset, and computing the proportion of replications in which the analysis correctly identifies a significant intervention effect. In all models, data collection from participants (for the primary outcomes) is assumed to take place at 3-month intervals throughout the trial. The participant dropout rate is assumed to be 2% per 3-month follow-up period, giving retention rates of approximately 92% at 12 months post-recruitment (the final follow-up for participants allocated to the first intervention group) and 87% at 21 months (final follow-up for participants allocated to the last intervention group). We assume all dropouts remain lost to follow-up for the remainder of the study.
We anticipate a mean cluster size of 3, with coefficient of variation of 0.5. For the purposes of simulating the recruited sample for the power calculations, we assume a truncated normal distribution with lower bound at 1 (rounded to the nearest integer). This results in a simulated cluster size distribution. We simulate 1000 datasets from the assumed data generating process (each including snowball recruitment from a base case of 15 index participants per region; allocation of clusters to intervention arms (sequences), stratified by region and cluster size (> 3, = 3); dropout over follow-up time periods (assumed missing completely at random); and calculation of WOMAC and SF-6D outcome values at each observed time point). For sensitivity analyses, we also estimate power for alternative designs with (1) 36 clusters with an average of 5 participants per cluster (maintaining the same total sample size of 180) and (2) 48 clusters with an average of 3 participants (resulting in total sample size of approximately 144 participants). The estimated study power for each scenario is reported in https://osf.io/8m6kt/. The budget allows for recruitment of 190 participants; to allow for uncertainty in cluster sizes, we have modelled here a simulated recruitment of 60 clusters (15 in each region), resulting in an expected 180 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
21/12/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 26803 0
New Zealand
State/province [1] 26803 0
Te Matau-a-Maui Hawke's Bay

Funding & Sponsors
Funding source category [1] 318062 0
Government body
Name [1] 318062 0
Health Research Council of New Zealand
Country [1] 318062 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320416 0
None
Name [1] 320416 0
Address [1] 320416 0
Country [1] 320416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316713 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316713 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 316713 0
New Zealand
Date submitted for ethics approval [1] 316713 0
14/08/2023
Approval date [1] 316713 0
02/11/2023
Ethics approval number [1] 316713 0
2023 EXP 15077

Summary
Brief summary
Exercise therapy, patient education, and weight loss when indicated are the first-line standard care recommended by international clinical practice guidelines for people with osteoarthritis. Many people with hip and/or knee osteoarthritis also have other chronic conditions, such as type 2 diabetes, prediabetes, heart disease and hypertension. Our previous research has demonstrated the effectiveness and feasibility of: a) an exercise programme for people with hip or knee osteoarthritis; and b) a primary care nurse-delivered healthy eating prediabetes intervention programme designed to facilitate regression to normoglycaemia for people with prediabetes and a body mass index greater than 25kg/m2. These two programmes have been combined with osteoarthritis education resources, and adapted to local context, and this trial seeks to determine the effectiveness of the pragmatic delivery of the combined exercise therapy, osteoarthritis education and healthy eating intervention programme as implemented in regional routine health delivery.
Trial website
Trial related presentations / publications
Public notes
Associated with Pilot Study: ACTRN12623001330639.
The researchers apologise for the inability to include macrons (tohuto or potae) in the Reo Maori kupu of this trial registration; this was an IT web platform limitation beyond our control.

Contacts
Principal investigator
Name 138758 0
Prof J. Haxby Abbott
Address 138758 0
University of Otago Medical School, PO Box 65, Dunedin 9054
Country 138758 0
New Zealand
Phone 138758 0
+64 272890863
Fax 138758 0
Email 138758 0
[email protected]
Contact person for public queries
Name 138759 0
Assoc. Prof. Kirsten Coppell
Address 138759 0
University of Otago, Nelson Clinical Base, Nelson Hospital, Tipahi Street, Nelson 7010
Country 138759 0
New Zealand
Phone 138759 0
+64 21 279 1641
Fax 138759 0
Email 138759 0
[email protected]
Contact person for scientific queries
Name 138760 0
J. Haxby Abbott
Address 138760 0
University of Otago Medical School, PO Box 65, Dunedin 9054
Country 138760 0
New Zealand
Phone 138760 0
+64 272890863
Fax 138760 0
Email 138760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified / anonymised data
When will data be available (start and end dates)?
01-10-2027 to 30-09-2036
Available to whom?
approved researchers for projects with satisfactory evidence of ethical approval
Available for what types of analyses?
research related to the new treatment programme or osteoarthritis.
How or where can data be obtained?
The PI and/or via the publicly available OSF repository for 'He Oranga mo te whanau' at: https://osf.io/ncrqs/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24419Study protocol https://osf.io/ncrqs/ 
24420Statistical analysis plan https://osf.io/ncrqs/ 
24421Other https://osf.io/ncrqs/ 



Results publications and other study-related documents

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