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Trial registered on ANZCTR


Registration number
ACTRN12624001407583
Ethics application status
Approved
Date submitted
28/10/2024
Date registered
28/11/2024
Date last updated
28/11/2024
Date data sharing statement initially provided
28/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Food is medicine: Testing 'produce prescription' for pregnant women with food insecurity and at high risk of gestational diabetes mellitus in Australia
Scientific title
A randomized controlled trial testing a produce prescription intervention versus usual care to reduce gestational weight gain in pregnant women at risk of gestational diabetes mellitus and with food insecurity
Secondary ID [1] 312166 0
None
Universal Trial Number (UTN)
Trial acronym
Produce Rx GDM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy at risk of Gestational Diabetes Mellitus 333878 0
Food Insecurity 335533 0
Condition category
Condition code
Metabolic and Endocrine 330552 330552 0 0
Diabetes
Diet and Nutrition 330553 330553 0 0
Other diet and nutrition disorders
Cardiovascular 330554 330554 0 0
Other cardiovascular diseases
Reproductive Health and Childbirth 332104 332104 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each intervention participant will receive a 'prescription' for healthy food boxes delivered to their homes weekly by the study food supplier until they have given birth. The prescription will also contain simple recipes using foods availability in the health food boxes.

Content of the healthy food boxes will be pre-determined by the study team and the food supplier, and will include fruit, vegetables, nuts and seeds, and low glycaemic index whole grain products that are appropriate for pregnant women and recommended by the Australian Dietary Guidelines. The amount provided will be tailored to household size, with the aim of supporting healthier food intake and it is not designed to replace all food intake.

The prescription will allow the participants to take part in telephone appointments (up to 30 minutes) up to three times between randomisation and 28 weeks of gestation at approximately 2, 4 and 8 weeks post-randomisation with a trained accredited dietitian to support improvement in diet quality. The decision to take part in these dietitian consults will be at the participant's discretion. The dietitian will provide dietary advice, including a specific focus on how to cook the healthy foods provided to the participants. Participants will be advised to avoid foods that they are allergic or intolerant to and continue their usual medications, and any changes to medication requirements will be at the discretion of their treating clinician. To monitor adherence to the intervention, study staff who conduct the diet consultations will log the number of dietary counselling sessions with each participant. Participants will also be asked to complete a self-administered Process Evaluation questionnaire related to produce acceptability and uptake at gestation weeks 24-28 and 35-38.

Each participant will receive a $100 voucher after the completion of data collection at baseline and mid-point, and $150 after data collection at the end-point (total $350). The vouchers can be used to purchase groceries at a local food retailer of their choice. There will be no specific recommendations about how the vouchers are to be spent.

At the end of the study, informant interviews (up to 40 minutes in duration) will be conducted by phone (i.e., Microsoft teams or Zoom audio function) with one to two purposely selected representatives each from the food supplier (Managing Directors/Chief Executive Officers and other staff engaged in the intervention), clinical staff, and study staff as well as 12 purposely selected intervention participants (with a range of characteristics).

A subset of 12 intervention participants will be invited to take part in a semi-structured interview (up to 30 minutes) to obtain an in-depth understanding of what worked or not, what and how the intervention could be improved, and what were the challenges and enablers of intervention uptake.

For the food supplier interviews, study staff are in contact with them as part of running the study and will ask who may be willing to be interviewed. For clinicians, relationships exist (some are collaborators on this study) and these contact details will be used to ask who may be willing to be interviewed and provide the Information Statement to them. For study staff, willing interviewees will self-nominate and access the Information Statement and use our usual means of contacting each other.

The interviews will seek to obtain an in-depth understanding of what worked (or not), for whom and how, challenges and facilitators, and any adaptations throughout the implementation process. For all key informant interviews (except among trial participants), verbal consent will be obtained at the start of the interviews as per the verbal consent script and consent will be audio-recorded.
Intervention code [1] 328650 0
Prevention
Comparator / control treatment
Participants in the control group will continue their usual medical care and medications as recommended by their doctors and antenatal care team.

Each participant will receive a $100 voucher after the completion of data collection at baseline and mid-point, and $150 after data collection at the end-point (total $350). The vouchers can be used to purchase groceries at a local food retailer of their choice. There will be no specific recommendations about how the vouchers are to be spent.
Control group
Active

Outcomes
Primary outcome [1] 338313 0
Gestational weight gain
Timepoint [1] 338313 0
Baseline (<16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [1] 435402 0
GDM (predefined dichotomous maternal outcome)
Timepoint [1] 435402 0
Data collected after childbirth
Secondary outcome [2] 440103 0
Pregnancy related hypertension (predefined dichotomous maternal outcome)- gestational hypertension, preeclampsia, eclampsia or preeclampsia superimposed on chronic hypertension.
Timepoint [2] 440103 0
Data collected after childbirth
Secondary outcome [3] 440204 0
Excess gestational weight gain (predefined dichotomous maternal outcome)
Timepoint [3] 440204 0
Data collected after childbirth
Secondary outcome [4] 440205 0
Caesarean section (predefined dichotomous maternal outcome)
Timepoint [4] 440205 0
Data collected after childbirth
Secondary outcome [5] 440206 0
Large for gestational age (predefined dichotomous neonatal outcome)
Timepoint [5] 440206 0
Data collected after childbirth
Secondary outcome [6] 440207 0
Preterm birth (predefined dichotomous neonatal outcome)
Timepoint [6] 440207 0
Data collected after childbirth
Secondary outcome [7] 440208 0
Stillbirth or neonatal death (predefined dichotomous neonatal outcome)
Timepoint [7] 440208 0
Data collected after childbirth
Secondary outcome [8] 440228 0
Diet quality
Timepoint [8] 440228 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [9] 440235 0
Physical activity
Timepoint [9] 440235 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [10] 440236 0
Blood pressure
Timepoint [10] 440236 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [11] 440240 0
Oral Glucose Tolerance Test
Timepoint [11] 440240 0
Baseline (< 16 weeks gestation) and 24-28 weeks gestation
Secondary outcome [12] 440241 0
Hba1c
Timepoint [12] 440241 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [13] 440242 0
Food security
Timepoint [13] 440242 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [14] 440243 0
Nutrition security
Timepoint [14] 440243 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [15] 440244 0
General emotional wellbeing
Timepoint [15] 440244 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [16] 440245 0
Eating disorder symptoms
Timepoint [16] 440245 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [17] 440246 0
Health-related quality of life
Timepoint [17] 440246 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [18] 441871 0
Medication use
Timepoint [18] 441871 0
Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [19] 441873 0
Acceptability of intervention (for intervention participants only)
Timepoint [19] 441873 0
During dietetic consults (week 2, 4 and 8 of the intervention)
Secondary outcome [20] 441874 0
Acceptability
Timepoint [20] 441874 0
24-28 weeks gestation and 34-38 weeks gestation
Secondary outcome [21] 441875 0
Feasibility (intervention participants only)
Timepoint [21] 441875 0
24-28 weeks gestation
Secondary outcome [22] 442216 0
Feasibility (other stakeholders)
Timepoint [22] 442216 0
End of study

Eligibility
Key inclusion criteria
* Pregnant women aged 18 years or over.

* At high risk of GDM according to ADIPS Guidelines (at least one of the following risk factors of GDM):
- previous hyperglycaemia in pregnancy
- previously elevated blood glucose level
- maternal age 40 years or over
- a family history of diabetes mellitus (1st degree relative with diabetes including sister with GDM)
- body mass index of >30 kg/m2
- previous macrosomia (baby with birthweight > 4500g or > 90th percentile)
- polycystic ovary syndrome
- medications (corticosteroids or antipsychotics)
- Asian, Indian subcontinent, Aboriginal, Torres Strait Islander, Maori, Pacific Islander, Middle Easter, non-white African ethnicity

* Women less than 16 weeks gestation.

* Food insecure based on a six-item questionnaire OR facing financial hardship based on a four-item questionnaire (adapted from the Household, Income and Labour Dynamics in Australia (HILDA) and Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE) surveys) OR has a Low-Income Health Care concession Card.

* Able to read or speak English OR speak one of the 'Top 2' languages spoken, other than English, by women in the antenatal clinic at each study site (Canterbury: Arabic and Banagali; Campbelltown: Arabic and Vietnamese; St George: Spanish and Mongolian; Nepean: Dari and Hindi).

* Singleton pregnancy confirmed by ultrasound.

* Planned antenatal care at the same or another participating trial centre (e.g., hospital or GP) throughout pregnancy.

* Lives within the distribution zone of the study food supplier.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pre-pregnancy BMI <23 kg/m2 for women with an Asian, Middle Eastern, Black African or African-Caribbean family background (as per NICE guidelines) or <25 kg/m2 for all other ethnicities
* Unable or unwilling to provide informed consent
* Pre-pregnancy type 1 or type 2 diabetes.
* Severe congenital abnormality on ultrasound.
* Termination planned.
* Anyone not planning to stay within their home in Sydney area for the remainder of their pregnancy.
* Living in a facility that provides meals.
* Does not have refrigerators at home for storing study foods.
* Existing medical conditions that severely limits dietary intake, requires individualised diets.
* Those with severe food allergies (but those with gluten or dairy intolerances can participate).
* Those with active cancer, patients with renal failure (stages 4 or 5), severe liver disease (stage 4), advanced heart failure (stage D) and psychiatric conditions requiring in-patient admission.
* People participating in any other lifestyle modification research projects.
* Another household member already participating in the study,

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done using an online computerised system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for each individual will be undertaken once they consent and provide baseline primary outcome data (weight) using an online computerised system in a 1:1 ratio with stratification by study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
316
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26613 0
Canterbury Hospital - Campsie
Recruitment hospital [2] 27202 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 27203 0
St George Hospital - Kogarah
Recruitment hospital [4] 27204 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 42654 0
2194 - Campsie
Recruitment postcode(s) [2] 43285 0
2560 - Campbelltown
Recruitment postcode(s) [3] 43286 0
2217 - Kogarah
Recruitment postcode(s) [4] 43287 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 316532 0
Government body
Name [1] 316532 0
Australian National Health and Medical Research Council Program Grant
Country [1] 316532 0
Australia
Funding source category [2] 317600 0
Other Collaborative groups
Name [2] 317600 0
Hort Innovation Frontier Funds
Country [2] 317600 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Country
Australia
Secondary sponsor category [1] 319908 0
None
Name [1] 319908 0
Address [1] 319908 0
Country [1] 319908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315325 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 315325 0
Ethics committee country [1] 315325 0
Australia
Date submitted for ethics approval [1] 315325 0
04/04/2024
Approval date [1] 315325 0
06/05/2024
Ethics approval number [1] 315325 0

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

Contacts
Principal investigator
Name 134342 0
Dr Megan Gow
Address 134342 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 134342 0
Australia
Phone 134342 0
+61421078958
Fax 134342 0
Email 134342 0
[email protected]
Contact person for public queries
Name 134343 0
Megan Gow
Address 134343 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 134343 0
Australia
Phone 134343 0
+61421078958
Fax 134343 0
Email 134343 0
[email protected]
Contact person for scientific queries
Name 134344 0
Megan Gow
Address 134344 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 134344 0
Australia
Phone 134344 0
+61421078958
Fax 134344 0
Email 134344 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
No
-

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24297Ethical approval  [email protected] Request can be made to Chief Investigator



Results publications and other study-related documents

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

Documents added automatically
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