Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001330639
Ethics application status
Approved
Date submitted
4/12/2023
Date registered
19/12/2023
Date last updated
19/12/2023
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a healthy food guidance programme and an exercise therapy programme for people with hip and knee osteoarthritis and at least one other chronic condition.
Scientific title
He Oranga mo te Whanau: a Pilot Study on the Management of Osteoarthritis (MOA) and the Prediabetes Intervention Package (PIP) for people with hip and knee osteoarthritis and co-morbidities
Secondary ID [1] 311063 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MOA-PIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 332186 0
Hip Osteoarthritis 332382 0
Prediabetes 332383 0
Diabetes 332384 0
Heart failure 332385 0
Coronary heart disease 332386 0
Hypertension 332387 0
Chronic obstructive pulmonary disease (COPD) 332388 0
Depression - mild to moderate 332390 0
Condition category
Condition code
Metabolic and Endocrine 328903 328903 0 0
Diabetes
Metabolic and Endocrine 328904 328904 0 0
Other metabolic disorders
Cardiovascular 328905 328905 0 0
Hypertension
Cardiovascular 328906 328906 0 0
Coronary heart disease
Cardiovascular 328907 328907 0 0
Other cardiovascular diseases
Respiratory 328908 328908 0 0
Chronic obstructive pulmonary disease
Mental Health 328909 328909 0 0
Depression
Musculoskeletal 328910 328910 0 0
Osteoarthritis

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

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.

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] 327508 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336714 0
% of people screened from the study general practice population that are eligible to participate in the study
Timepoint [1] 336714 0
Baseline.
Data will be obtained from the study database at the conclusion of study recruitment.
Primary outcome [2] 336715 0
% of people that attend each of the six prediabetes intervention package (PIP) visits
Timepoint [2] 336715 0
Baseline, 2-3 weeks, 6 weeks, 3 months, 4-5 months, 6 months.
Data will be obtained from the study database.
Primary outcome [3] 336716 0
% of people that attend each of the the 12 weekly physiotherapy exercise sessions
Timepoint [3] 336716 0
Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12.
Data will be obtained from the study database.
Secondary outcome [1] 429419 0
% of people from the study general practice population who are eligible to participate in the study and provide written informed consent
Timepoint [1] 429419 0
Baseline
Data will be obtained from the study database at the conclusion of study enrolment.
Secondary outcome [2] 429420 0
% of people who provide written informed consent that complete all of the baseline assessment
Timepoint [2] 429420 0
Baseline
Data will be obtained from the study database at the conclusion of study

Eligibility
Key inclusion criteria
A clinical diagnosis of 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), or
- mild-to-moderate depression.
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,
* 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
Date of last participant enrolment
Anticipated
16/02/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 25999 0
New Zealand
State/province [1] 25999 0
Hawke's Bay

Funding & Sponsors
Funding source category [1] 315320 0
Government body
Name [1] 315320 0
Health Research Council of New Zealand
Country [1] 315320 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Main Campus Physical Address: 362 Leith Street, North Dunedin, Dunedin 9016; Postal Address: PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 317373 0
None
Name [1] 317373 0
Address [1] 317373 0
Country [1] 317373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314242 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314242 0
C/- Health and Disability Ethics Committees, Ministry of Health - Physical Address: 133 Molesworth Street, Thorndon, Wellington 6011; Postal Address: Health and Disability Ethics Committees, Ministry of Health, PO Box 5013, Wellington 6140
Ethics committee country [1] 314242 0
New Zealand
Date submitted for ethics approval [1] 314242 0
14/08/2023
Approval date [1] 314242 0
02/11/2023
Ethics approval number [1] 314242 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 and this pilot study seeks to determine recruitment rates and evaluate organisational processess associated with the study and the delivery of the combined exercise therapy and healthy eating intervention programme to facilitate the smooth running of the full study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49274 0
Prof Haxby Abbott
Address 49274 0
Centre for Musculoskeletal Outcomes Research (CMOR), Orthopaedic Surgery Section, Department of Surgical Sciences, Otago Medical School, University of Otago, PO Box 56, DUNEDIN 9054
Country 49274 0
New Zealand
Phone 49274 0
+64 27 289 0863
Fax 49274 0
Email 49274 0
[email protected]
Contact person for public queries
Name 49275 0
A/Prof Kirsten Coppell
Address 49275 0
c/- Butterfly House, Nelson Hospital, Tipahi Street, Nelson South, NELSON 7010
Country 49275 0
New Zealand
Phone 49275 0
+64 21 279 1641
Fax 49275 0
Email 49275 0
[email protected]
Contact person for scientific queries
Name 49276 0
A/Prof Kirsten Coppell
Address 49276 0
c/- Butterfly House, Nelson Hospital, Tipahi Street, Nelson South, NELSON 7010
Country 49276 0
New Zealand
Phone 49276 0
+64 21 279 1641
Fax 49276 0
Email 49276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study to inform the full trial. As there is no control group, it is not really applicable for inclusion in IPD meta-analysis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21083Ethical approval  [email protected] Or email: [email protected] 366554-(Uploaded-18-12-2023-13-26-58)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.