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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
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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
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Secondary ID [1]
312166
0
None
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Universal Trial Number (UTN)
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Trial acronym
Produce Rx GDM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Food Insecurity
335533
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Pregnancy at risk of Gestational Diabetes Mellitus
333878
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Condition category
Condition code
Metabolic and Endocrine
330552
330552
0
0
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Diabetes
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Cardiovascular
330554
330554
0
0
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Other cardiovascular diseases
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Diet and Nutrition
330553
330553
0
0
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Other diet and nutrition disorders
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Reproductive Health and Childbirth
332104
332104
0
0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328650
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
338313
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Gestational weight gain
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Assessment method [1]
338313
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Weight measurements will be done using calibrated scales with participants wearing light indoor clothing and with shoes removed. Body weight for each participant at each antenatal visit will be measured in kilograms and measured twice with the results averaged. Gestational weight gain will be calculated as change in weight from baseline (< 16 weeks) to 34-38 weeks.
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Timepoint [1]
338313
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Baseline (<16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [1]
440240
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Oral Glucose Tolerance Test
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Assessment method [1]
440240
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After overnight fast, participants will attend their antenatal visit and consume liquid containing 75grams of glucose. Blood samples will be taken prior to and at 60 and 120 minutes after consuming the liquid. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be calculated as fasting glucose (mmol/L) x fasting insulin (mU/L) /22.5.
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Timepoint [1]
440240
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Baseline (< 16 weeks gestation) and 24-28 weeks gestation
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Secondary outcome [2]
440242
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Food security
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Assessment method [2]
440242
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Assessed using the United States Departmentof Agriculture 6-item household food security survey.
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Timepoint [2]
440242
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [3]
440205
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Caesarean section (predefined dichotomous maternal outcome)
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Assessment method [3]
440205
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Determined from patient medical record review, whether or not caesarean section was performed during delivery.
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Timepoint [3]
440205
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Data collected after childbirth
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Secondary outcome [4]
440204
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Excess gestational weight gain (predefined dichotomous maternal outcome)
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Assessment method [4]
440204
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Assessed based on Institute of Medicine criteria i.e., for those with pre-pregnancy BMI between 25 to <30kg/m2 and BMI greater than or equal to 30kg/m2, rate of weight gain in the 2nd and 3rd trimester >0.32 and >0.27kg/week, respectively will be considered excess gestational weight gain. Weight assessed using digital scales.
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Timepoint [4]
440204
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Data collected after childbirth
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Secondary outcome [5]
435402
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GDM (predefined dichotomous maternal outcome)
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Assessment method [5]
435402
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Assessed using the oral glucose tolerance test (either 'early' OGTT at <16 weeks or 'standard' OGTT at 24-28 weeks gestation) and diagnosed according to the Australasian Diabetes in Pregnancy Society (ADIPS) Consensus Guidelines for the Testing and Diagnosis of Gestational Diabetes Mellitus in Australia.
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Timepoint [5]
435402
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Data collected after childbirth
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Secondary outcome [6]
440228
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Diet quality
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Assessment method [6]
440228
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Measured using a food frequency questionnaire and assessed according to the Alternate Healthy Eating Index by assigning continuous scores (out of 10) to intakes of vegetables, fruits, whole grains, nuts and legume protein, total intake of long-chain omega-3 fatty acids, percentage of total energy from trans fat, sodium, and alcohol, with a higher AHEI score reflecting better diet quality.
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Timepoint [6]
440228
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [7]
441871
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Medication use
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Assessment method [7]
441871
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Questionnaire adapted from validated Medication Adherence Questionnaire
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Timepoint [7]
441871
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [8]
440207
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Preterm birth (predefined dichotomous neonatal outcome)
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Assessment method [8]
440207
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Determined from patient medical record, preterm birth will be defined as born at <37 weeks gestation
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Timepoint [8]
440207
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Data collected after childbirth
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Secondary outcome [9]
440245
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Eating disorder symptoms
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Assessment method [9]
440245
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Assessed using the Eating Disorder Examination Questionnaire Short Form (EDE-QS)
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Timepoint [9]
440245
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [10]
440244
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General emotional wellbeing
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Assessment method [10]
440244
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Assessed using the World Health Organisation 5 Well-Being Index
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Timepoint [10]
440244
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [11]
440208
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Stillbirth or neonatal death (predefined dichotomous neonatal outcome)
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Assessment method [11]
440208
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Determined from patient medical record, if still birth occurred, or neonatal death occurred after birth
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Timepoint [11]
440208
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Data collected after childbirth
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Secondary outcome [12]
440206
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Large for gestational age (predefined dichotomous neonatal outcome)
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Assessment method [12]
440206
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Determined from patient medical record (i.e. infant birth weight) large for gestational age will be defined as birth weight > 90th percentile based on Gestation Related Optimal Weight (GROW) customised weight centiles.
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Timepoint [12]
440206
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Data collected after childbirth
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Secondary outcome [13]
440241
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Hba1c
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Assessment method [13]
440241
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Point-of-care assessment of HbA1c will be carried out by study midwife as part of the participant's antenatal care visit by conducting a finger-prick blood test.
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Timepoint [13]
440241
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [14]
440103
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Pregnancy related hypertension (predefined dichotomous maternal outcome)- gestational hypertension, preeclampsia, eclampsia or preeclampsia superimposed on chronic hypertension.
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Assessment method [14]
440103
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Diagnosed clinically as part of the antenatal clinic visit according to the International Society for the Study of Hypertension in Pregnancy guidelines. Blood pressure assessed using calibrated sphygmomanometer.
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Timepoint [14]
440103
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Data collected after childbirth
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Secondary outcome [15]
440246
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Health-related quality of life
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Assessment method [15]
440246
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Assessed using Eq-5D-5L
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Timepoint [15]
440246
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [16]
440235
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Physical activity
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Assessment method [16]
440235
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Measured using the International Physical Activity Questionnaire
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Timepoint [16]
440235
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [17]
442216
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Feasibility (other stakeholders)
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Assessment method [17]
442216
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Semi-structured one-on-one interviews will also be conducted by a member of the research team with clinical staff, food suppliers and research staff
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Timepoint [17]
442216
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End of study
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Secondary outcome [18]
441874
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Acceptability
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Assessment method [18]
441874
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Process evaluation questionnaire, developed for this study (intervention participants only)
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Timepoint [18]
441874
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24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [19]
441875
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Feasibility (intervention participants only)
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Assessment method [19]
441875
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Semi-structured one-on-one interviews conducted by a member of the research team with 12 participants
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Timepoint [19]
441875
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24-28 weeks gestation
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Secondary outcome [20]
441873
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Acceptability of intervention (for intervention participants only)
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Assessment method [20]
441873
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Three routine questions, designed specifically for this research project and another produce prescription intervention trial conducted by our team, are asked during dietetic consultations to assess acceptability of the healthy food box (including reach, dose received).
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Timepoint [20]
441873
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During dietetic consults (week 2, 4 and 8 of the intervention)
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Secondary outcome [21]
440243
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Nutrition security
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Assessment method [21]
440243
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Assessed using a 2-item Nutrition Security Screener (Mozaffarian D. Measuring And Addressing Nutrition Security To Achieve Health And Health Equity. Updated March 30, 2023. https://www.healthaffairs.org/content/briefs/measuring-and-addressing-nutrition-security-achieve-health-and-health-equity)
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Timepoint [21]
440243
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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Secondary outcome [22]
440236
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Blood pressure
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Assessment method [22]
440236
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Measured during antenatal visits using a calibrated sphygmomanometer. Participants will need to be seated and one blood pressure measurement will be collected per visit.
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Timepoint [22]
440236
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Baseline (< 16 weeks gestation), 24-28 weeks gestation and 34-38 weeks gestation
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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,
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done using an online computerised system.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/12/2024
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Actual
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Date of last participant enrolment
Anticipated
31/05/2026
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Actual
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Date of last data collection
Anticipated
30/11/2026
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Actual
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Sample size
Target
316
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
27204
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Nepean Hospital - Kingswood
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Recruitment hospital [2]
27202
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
27203
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St George Hospital - Kogarah
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Recruitment hospital [4]
26613
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Canterbury Hospital - Campsie
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Recruitment postcode(s) [1]
43286
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2217 - Kogarah
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Recruitment postcode(s) [2]
42654
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2194 - Campsie
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Recruitment postcode(s) [3]
43287
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2747 - Kingswood
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Recruitment postcode(s) [4]
43285
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2560 - Campbelltown
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Funding & Sponsors
Funding source category [1]
316532
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Government body
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Name [1]
316532
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Australian National Health and Medical Research Council Program Grant
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Address [1]
316532
0
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Country [1]
316532
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Australia
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Funding source category [2]
317600
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Other Collaborative groups
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Name [2]
317600
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Hort Innovation Frontier Funds
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Address [2]
317600
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Country [2]
317600
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
The George Institute for Global Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319908
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None
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Name [1]
319908
0
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Address [1]
319908
0
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Country [1]
319908
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315325
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Sydney Local Health District HREC – Concord Repatriation General Hospital
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Ethics committee address [1]
315325
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http://www.slhd.nsw.gov.au/concord/ethics/
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Ethics committee country [1]
315325
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Australia
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Date submitted for ethics approval [1]
315325
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04/04/2024
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Approval date [1]
315325
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06/05/2024
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Ethics approval number [1]
315325
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Summary
Brief summary
Healthy eating advice is recommended by guidelines as a mainstay therapy for women at high risk or those who have developed gestational diabetes mellitus (GDM), prior to pharmacotherapy. GDM is a condition characterised by higher-than-normal blood sugar levels during pregnancy with immediate and long-term health consequences. 'Food is Medicine' programs aim to integrate nutrition interventions into the health care system to help improve the clinical population's diets and complement pharmacologic treatment of diseases. 'Produce prescription' is one such approach whereby clinicians and other health professionals prescribe free or subsidised healthy foods to people who experience food insecurity as part of their treatment. We will assess the effect of produce prescription on gestational weight gain for women with food insecurity and at high risk of GDM compared to usual care. We will conduct a randomised control trial of a produce prescription intervention in pregnancy women at high risk of GDM, who have difficulty buying or eating nutritious food. Intervention participants will be prescribed produce boxes from 14-18 weeks gestation to 34-38 weeks gestation. In addition, intervention participants will also receive three consultations with a dietitian. Predefined, composite secondary maternal (GDM, pregnancy related hypertension, excess gestational weight gain, caesarean section) and neonatal (large for gestational age, preterm birth, mortality) outcomes will be assessed. Diet quality, cardiometabolic outcomes, food and nutrition security, patient-reported outcome measures, and the feasibility and acceptability of the produce prescription program will also be assessed. Finally, a sub-sample of participants will be interviewed to explore how the program worked (or did not work) for them, and ways the program can be improved and scaled up. We hypothesise that the intervention group will have improved diet quality and reduced gestational weight gain during pregnancy which will prevent a range of pregnancy complications. We anticipate that the program will be highly acceptable to pregnant women and suitable for scale up as part of healthcare.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134342
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Dr Megan Gow
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Address
134342
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The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
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Country
134342
0
Australia
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Phone
134342
0
+61421078958
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Fax
134342
0
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Email
134342
0
[email protected]
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Contact person for public queries
Name
134343
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Megan Gow
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Address
134343
0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
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Country
134343
0
Australia
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Phone
134343
0
+61421078958
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Fax
134343
0
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Email
134343
0
[email protected]
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Contact person for scientific queries
Name
134344
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Megan Gow
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Address
134344
0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
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Country
134344
0
Australia
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Phone
134344
0
+61421078958
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Fax
134344
0
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Email
134344
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical 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
No additional documents have been identified.
Download to PDF