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Trial registered on ANZCTR


Registration number
ACTRN12622000825752
Ethics application status
Approved
Date submitted
3/06/2022
Date registered
10/06/2022
Date last updated
22/05/2023
Date data sharing statement initially provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Energy, Neurosensory and Eating Responses durinG pregnancY (ENERGY cohort)
Scientific title
How do sensory shifts shape our diet? - Testing the neural mechanisms underpinning nutrient selection in adult women who are and are not planning to conceive
Secondary ID [1] 307281 0
None
Universal Trial Number (UTN)
Trial acronym
ENERGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 326543 0
Inadequate nutrition 326544 0
Obesity 326545 0
Condition category
Condition code
Reproductive Health and Childbirth 323803 323803 0 0
Normal pregnancy
Diet and Nutrition 323804 323804 0 0
Obesity
Metabolic and Endocrine 323805 323805 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is a prospective longitudinal study that will follow pregravid women (women who have not experienced pregnancy) for up two years. The study recruit a group of women planing to conceive and test for changes in diet, neurosensory responses, and metabolisms across the reproductive cycle - from pre-pregnancy, through pregnancy, and up to 1-year post-pregnancy.

The following questionnaires and assessments will be used throughout the study:
- Demographic Information (Baseline (study entry) 1 only)
- Study-specific questionnaire on reproductive history, diet, and other health related beahviours (Baseline (study entry) 1 only)
- Food Craving Inventory; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Dutch Eating Behaviour Questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Global Physical Activity Questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Hospital Anxiety and Depression Scale; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Study-specific pregnancy health questionnaire; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Suprathreshold sensory tests; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Intensity and hedonic perception using standard scaling methods; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Anthropometric measures (including height, weight, skinfold thickness); Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Basal metabolic rate (via open-circuit indirect calorimetry); Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Blood samples; Baseline (study entry) and 1-year post-pregnancy (Pregnancy Cohort) or 21-months post-enrolment (Control Cohort)
- Ad libitum intake from a buffet; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Dietary preference two-alternative forced choice task; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
- Four-day food record; Pregnancy Cohort: Baseline (study entry), First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control (non-pregnant) Cohort: Baseline (study entry), Three months, Six months, Nine months, Twelve months, 21 months post-enrolment

Questionnaires can be completed online and will take around 15-30 minutes. Sensory assessments and physiological tests will take place face-to-face at the University of Otago Food Science Sensory Lab over four consecutive days, each taking 1-2 hours. The assessments will be conducted by trained research staff.


Intervention code [1] 323721 0
Not applicable
Comparator / control treatment
A group pregravid women with no plans to conceive in the next 24 months will serve as the comparator.
Control group
Active

Outcomes
Primary outcome [1] 331590 0
Supra-threshold sensitivity changes: 8-step method of limits forced choice task across sensory modalities (olfaction, gustation, vision, tactile). A composite supra-threshold sensitivity will be quantified by d'.
Timepoint [1] 331590 0
Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment
Primary outcome [2] 331591 0
Dietary intake changes: macronutrient intake from 4-day weighed food record. Participant responses on this battery will be transferred into daily energy intake (in kj) of different nutrient sources using FoodWorks (Xyris Software, Australia).
Timepoint [2] 331591 0
Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment
Primary outcome [3] 331592 0
Metabolic changes: Basal Metabolic Rate will be assessed by measuring carbon dioxide production and oxygen consumption during a 30-min period, using open-circuit indirect calorimetry (COSMED, Italy). For this test, participants will be asked to stay in a supine position, awake with minimal movements, in a thermo-neutral room (22-26°C).
Timepoint [3] 331592 0
Pregnancy cohort: 1-year post-pregnancy
Control cohort: 21 months post-enrolment
Secondary outcome [1] 410354 0
Changes in supra-threshold sensitivity: 8-step method of limits forced choice task across sensory modalities (olfaction, gustation, vision, tactile). A composite supra-threshold sensitivity will be quantified by d'.
Timepoint [1] 410354 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [2] 410355 0
Dietary changes: macronutrient intake from 4-day weighed food record. Participant responses on this battery will be transferred into daily energy intake (in kj) of different nutrient sources using FoodWorks (Xyris Software, Australia).
Timepoint [2] 410355 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [3] 410356 0
Metabolic changes: Basal Metabolic Rate will be assessed by measuring carbon dioxide production and oxygen consumption during a 30-min period, using open-circuit indirect calorimetry (COSMED, Italy). For this test, participants will be asked to stay in a supine position, awake with minimal movements, in a thermo-neutral room (22-26°C).
Timepoint [3] 410356 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [4] 410577 0
Changes in intensity: Stimuli will be presented at concentrations 4 times higher than the population recognition threshold using the generalised Labelled Magnitude Scale (gLMS)
Timepoint [4] 410577 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [5] 410578 0
Changes in hedonic preference: Stimuli will be presented at concentrations 4 times higher than the population recognition threshold hedonic perception measured using the Labelled Affective Magnitude scale (LAMs).
Timepoint [5] 410578 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [6] 410579 0
Changes in ad libitum intake: participants will be presented with a buffet consisting of an equal number of carbohydrate, fat, and protein rich food items which participants can consume ad libitum. Intake of each item will be weighed and recorded, and the data will be transformed into dietary composition in % Energy.
Timepoint [6] 410579 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [7] 410580 0
Changes in dietary preference: Participants will also complete a computerised food-choice task. Each trial will present two food images side-by-side and participants will be asked to indicate their choice of food item within 3 seconds. Each participant’s probabilities of choosing foods associated with the three macronutrients will be computed.
Timepoint [7] 410580 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [8] 410581 0
Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Insulin will be measured via radioimmunoassay (Milliplex, USA).
Timepoint [8] 410581 0
Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment
Secondary outcome [9] 410582 0
Metabolic changes: Body mass index will be measured using height (measured in cm using a stadiometer) and weight (measured in kg using calibrated scales).
Timepoint [9] 410582 0
Pregnancy Cohort; First trimester, Second trimester, Third trimester, 3-months post-pregnancy, 1-year post-pregnancy
Control Cohort: Three months, Six months, Nine months, Twelve months, 21 months post-enrolment
Secondary outcome [10] 410756 0
Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Ghrelin will be measured via radioimmunoassay (Milliplex, USA).
Timepoint [10] 410756 0
Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment
Secondary outcome [11] 410757 0
Metabolic changes: Blood samples will be taken at Timepoint 1 and Timepoint 6. Glucose- dependent insulinotropic peptide will be measured via radioimmunoassay (Milliplex, USA).
Timepoint [11] 410757 0
Timepoint 1 and Timepoint 6
Pregnancy Cohort: Enrolment and 1-year post-birth
Control Cohort: Enrolment and 21-months post-enrolment

Eligibility
Key inclusion criteria
• Women
• 18-45 years
• No previous pregnancy beyond 20 weeks
• No history of neurological disease or metabolic conditions
• No known sensory dysfunctions.

Women planning to conceive within the next 12 months will be assigned to the Pregnancy Cohort (PC) and women with no short-term plans for conception (i.e., do not plan to conceive within the next 24 months) will be assigned to the Control Cohort (CC).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded if they are currently pregnant or taking oral contraception. Participants will be excluded if they have had gender affirming surgery or hormone treatment procedures.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The total sample size of =130 (65 pregnant women and 65 controls) is powered on previously reported metabolic measures across pregnancy for parallel-arm studies, with power at 0.80 and an attrition rate at 10%. Initial recruitment of 165 women contemplating pregnancy assumes that around 50% of participants will be conceive within 12 months and that we will be able to retain the majority (more than 75%) of women who conceive during this period. We will ensure that the composition of the control cohort (n=65) will be comparable in ethnicity, age, and socioeconomic status.
We will conduct a longitudinal data analysis using linear mixed models to assess changes in the response outcomes over time. Multivariate model will be used where comparing multiple outcomes. The model will be adjusted for age, ethnicity, and socioeconomic status. All tests will be two-sided at a 5% level of significance. Adjusted means and mean different will be reported with the 95% Confidence Interval (CI) and p value. Sensitivity analyses will be conducted using dichotomous groupings such as high vs low sensitivity, high vs low BMI, ethnicity (where sufficient cases reported). Baseline characteristics of participants will be summarised descriptively for the pregnancy and control cohorts. Continuous variables will be summarised by mean and standard deviation (SD) with missing data reported but excluded. Categorical data will be summarised as frequencies (n) and percentages (%).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment outside Australia
Country [1] 24817 0
New Zealand
State/province [1] 24817 0
Dunedin, Auckland

Funding & Sponsors
Funding source category [1] 311578 0
Charities/Societies/Foundations
Name [1] 311578 0
Royal Society of New Zealand
Country [1] 311578 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313000 0
None
Name [1] 313000 0
Address [1] 313000 0
Country [1] 313000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311027 0
University of Otago Ethics Committee (Health)
Ethics committee address [1] 311027 0
Ethics committee country [1] 311027 0
New Zealand
Date submitted for ethics approval [1] 311027 0
08/04/2022
Approval date [1] 311027 0
06/05/2022
Ethics approval number [1] 311027 0
H22/047

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

Contacts
Principal investigator
Name 119742 0
Dr Mei Peng
Address 119742 0
Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 119742 0
New Zealand
Phone 119742 0
+64 034794052
Fax 119742 0
Email 119742 0
mei.peng@otago.ac.nz
Contact person for public queries
Name 119743 0
Jessica McCormack
Address 119743 0
Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 119743 0
New Zealand
Phone 119743 0
+64 03 479 7566
Fax 119743 0
Email 119743 0
jessica.mccormack@otago.ac.nz
Contact person for scientific queries
Name 119744 0
Mei Peng
Address 119744 0
Food Science
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 119744 0
New Zealand
Phone 119744 0
+64 034794052
Fax 119744 0
Email 119744 0
mei.peng@otago.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?
De-identified and anonymised data may be made available.
De-identified data may be included in published study results including, but not limited to, peer-reviewed publications, clinical trial registry websites, scientific meetings, and regulatory / marketing submissions.
When will data be available (start and end dates)?
Following publication, no end date.
Available to whom?
De-identified data will only be made available to New Zealand researchers on request made to the Principal Investigator detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific eligibility criteria by data custodians. Future use of de-identified data in New Zealand will be consented to by participants.
Available for what types of analyses?
Each application will be reviewed based on scientific quality and robustness of the proposed statistical analysis plan by the Principal Investigator and Trial Steering Committee.
How or where can data be obtained?
Access will be subject to approval of the Principal Investigator. Anonymised data collected in the study may be submitted to Otago University Research archive for the purpose of ensuring reproducibility, transparency, integrity and fidelity of our study design and analysis methods.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16290Study protocol    Manuscript in preparation
16291Informed consent form    384171-(Uploaded-03-06-2022-09-11-04)-Study-related document.docx
16292Ethical approval    384171-(Uploaded-03-06-2022-09-12-28)-Study-related document.pdf



Results publications and other study-related documents

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