Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000806864
Ethics application status
Approved
Date submitted
12/03/2021
Date registered
25/06/2021
Date last updated
12/11/2021
Date data sharing statement initially provided
25/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-designing a Pacific diabetes prevention program with families and communities
Scientific title
Effect of a co-designed Pacific diabetes prevention program for improving the health and wellbeing of families and communities
Secondary ID [1] 303680 0
Nil.
Universal Trial Number (UTN)
U1111-1266-0219
Trial acronym
F-DIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 321076 0
prediabetes 321077 0
Condition category
Condition code
Diet and Nutrition 318882 318882 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 318883 318883 0 0
Diabetes
Diet and Nutrition 319316 319316 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with a recently diagnosed prediabetes and/or diabetes (defined by having an HbA1c test in the last 12 months) will be invited to join the study from Phase 1 of the study, that focuses on co-designing the intervention programme. The co-design programme will be delivered to the community over a 24 week period, every week for up to 2 hours per meeting. These co-design meetings will be conducted in face-to-face workshops, delivered by the Community Coordinator (who is already trained in the co-design methodology).

Phase 2 study participants include the same participants with prediabetes/diabetes diagnosis from phase 1, and their families (approximately 100 individuals >18years old).
It is anticipated that the co-designed life-style based and behavioural change intervention programme may include weekly activities, such as increased physical activities (eg. organised community 4km walks, community-based fitness classes), and behavioural change activities (eg. educational modules related to cooking and nutritional skills). The intervention programme will be measured at baseline (time-point 1: week 0) and at post-intervention (time-point 2: week 24).

Data collection at Time-point 1:
• Socio-demographic data: date of birth, gender, ethnicity, highest education level, and annual household income;
• Anthropometry: self-reported weight (kilograms) and height (centimetres); blood pressure; diet diversity
• Health status: self-reported health condition(s) defined as being told by a doctor that they have this condition, including prediabetes, diabetes, and heart disease;
• Holistic wellbeing (for Pasifika participants): spiritual, physical, mental and family wellbeing measured by 10-items based on the Fonofale Model. All answers are measured on a 5-point Likert scale.

Data collection at Time-point 2:
Anthropometry: self-reported weight (kilograms) and height (centimetres); blood pressure; diet diversity
• Health status: self-reported health condition(s) defined as being told by a doctor that they have this condition, including prediabetes, diabetes, and heart disease;
• Holistic wellbeing (for Pasifika participants): spiritual, physical, mental and family wellbeing measured by 10-items based on the Fonofale Model. All answers are measured on a 5-point Likert scale.
Intervention code [1] 320279 0
Lifestyle
Intervention code [2] 320280 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326824 0
The primary outcome is family adherence to a co-designed healthy lifestyle behavior change programme to reduce prediabetes and diabetes levels, over a 6 month period. This will primarily be determined by a positive change in anthropometric measurements (eg. decrease in weight (kg), reduced BMI status, and improved dietary behaviors).
Timepoint [1] 326824 0
At baseline (week 0) and post-intervention (week 24), Phase 1 / year 1 of the study, data collection includes:
Anthropometry: self-reported weight (kilograms) and height (centimeters); blood pressure; diet diversity.

Positive change in anthropometric measurements (eg. decrease in weight (kg), reduced BMI status, and improved dietary behaviors).
Primary outcome [2] 327261 0
Improved physical activity
Timepoint [2] 327261 0
At baseline (week 0) and post-intervention (week 24), Phase 1 / year 1 of the study, data collection includes:

Improved physical activity level as determined by the Physical Activity (using 6 minute walking test)
Primary outcome [3] 327263 0
Overall improved health and wellbeing of the Pacific participants as a result of the intervention programme
Timepoint [3] 327263 0
At baseline (week 0) and post-intervention (week 24) using the FonoFale Health and Wellbeing questionnaire
Secondary outcome [1] 392813 0
To examine whether co-designing a family diabetes intervention programme is practically feasible for Pacific families.
Timepoint [1] 392813 0
The secondary outcome will involves mini-focus groups (phase 3 / year 2 of the study). end date 30 October 2022. The outcome will be assessed in relation to implementation of the program 6 months post intervention of phase .

Eligibility
Key inclusion criteria
The inclusion criteria: Pacific ethnicity (self-identified), with at least one family member at high risk of developing diabetes (defined by having a BMI>30 and high blood-pressure) and resides in a moderate-high deprivation area.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-Pacific participants; Has had chronic diabetes and have had medical complications related to diabetes longer than 12months; Has not been amendable to previous interventions offered (ie. non-compliant).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
do not qualify as a random order 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
Efficacy
Statistical methods / analysis
A full statistical analysis plan will be developed a priori by our research centre statistician to guide final analysis and reporting. No interim analyses will be undertaken during the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2021
Actual
27/07/2021
Date of last participant enrolment
Anticipated
2/08/2021
Actual
9/08/2021
Date of last data collection
Anticipated
30/11/2022
Actual
9/08/2021
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 23534 0
New Zealand
State/province [1] 23534 0
South Waikato region

Funding & Sponsors
Funding source category [1] 308098 0
Government body
Name [1] 308098 0
National Science Challenge: Healthier Lives
Country [1] 308098 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Research Centre for Hauora and Health, College of Health, Massey University, PO Box 756, Wellington 6140, New Zealand
Country
New Zealand
Secondary sponsor category [1] 308844 0
Individual
Name [1] 308844 0
Prof Jeroen Douwes
Address [1] 308844 0
Research Centre for Hauora and Health, College of Health, Massey University, PO Box 756, Wellington 6140, New Zealand
Country [1] 308844 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308085 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308085 0
Ethics committee country [1] 308085 0
New Zealand
Date submitted for ethics approval [1] 308085 0
15/06/2021
Approval date [1] 308085 0
19/07/2021
Ethics approval number [1] 308085 0
21/CEN/176

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109478 0
Dr Riz Firestone
Address 109478 0
Research Centre for Hauora and Health, Massey University
PO Box 756
Wellington 6140
Country 109478 0
New Zealand
Phone 109478 0
+64 4 9793107
Fax 109478 0
Email 109478 0
[email protected]
Contact person for public queries
Name 109479 0
Riz Firestone
Address 109479 0
Research Centre for Hauora and Health Massey University
PO Box 756
Wellington 6140
Country 109479 0
New Zealand
Phone 109479 0
+64 4 9793107
Fax 109479 0
Email 109479 0
[email protected]
Contact person for scientific queries
Name 109480 0
Riz Firestone
Address 109480 0
Research Centre for Hauora and Health Massey University
PO Box 756
Wellington 6140
Country 109480 0
New Zealand
Phone 109480 0
+64 4 9793107
Fax 109480 0
Email 109480 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?
Base line data and post intervention data as outlined in phases 1 and 2, in particular: Anthropometry: self-reported weight (kgs) and height (cm); blood pressure; diet diversity
Health status: self-reported health condition(s) defined as being told by a doctor that they have this condition;
Holistic wellbeing: spiritual, physical, mental and family wellbeing measured by 5-point Likert scale
When will data be available (start and end dates)?
Immediately following initial publication and for only available for 5 years following the main results of the study
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the Research Team
Available for what types of analyses?
Only to align with the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Dr R.T. Firestone [email protected] +6449793107)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11430Study protocol    381605-(Uploaded-21-04-2021-15-42-39)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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