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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]

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

prediabetes

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Improved physical activity

Timepoint [2]

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]

Overall improved health and wellbeing of the Pacific participants as a result of the intervention programme

Timepoint [3]

At baseline (week 0) and post-intervention (week 24) using the FonoFale Health and Wellbeing questionnaire

Secondary outcome [1]

To examine whether co-designing a family diabetes intervention programme is practically feasible for Pacific families.

Timepoint [1]

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]

New Zealand

State/province [1]

South Waikato region

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Science Challenge: Healthier Lives

Address [1]

Hosted by the University of Otago, University of Otago, PO, Box 56 Dunedin 9054, New Zealand.

Country [1]

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]

Individual

Name [1]

Prof Jeroen Douwes

Address [1]

Research Centre for Hauora and Health, College of Health, Massey University, PO Box 756, Wellington 6140, New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/06/2021

Approval date [1]

19/07/2021

Ethics approval number [1]

21/CEN/176

Summary

Brief summary

The distribution of and access to resources to enable better health and wellbeing for Pacific families with members who have long-term conditions, continues to be unequal, and lacks cultural responsiveness that is acceptable to Pacific groups living in hard to reach regions. This project uses a co-design approach, and the central research questions are: Is a family-centered diabetes intervention programme for Pacific families an effective approach to prevent diabetes?   The impact of the overall research programme will provide a methodological approach that can be replicated in other communities and ethnic groups.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Riz Firestone

Address

Research Centre for Hauora and Health, Massey University
PO Box 756
Wellington 6140

Country

New Zealand

Phone

+64 4 9793107

Fax

r.t.firestone@massey.ac.nz

Contact person for public queries

Name

Riz Firestone

Address

Research Centre for Hauora and Health Massey University
PO Box 756
Wellington 6140

Country

New Zealand

Phone

+64 4 9793107

Fax

r.t.firestone@massey.ac.nz

Contact person for scientific queries

Name

Riz Firestone

Address

Research Centre for Hauora and Health Massey University
PO Box 756
Wellington 6140

Country

New Zealand

Phone

+64 4 9793107

Fax

r.t.firestone@massey.ac.nz

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 r.t.firestone@massey.ac.nz +6449793107)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11430	Study protocol					381605-(Uploaded-21-04-2021-15-42-39)-Study-related document.docx

Results publications and other study-related documents

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