Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001441707
Ethics application status
Approved
Date submitted
31/10/2022
Date registered
10/11/2022
Date last updated
23/06/2024
Date data sharing statement initially provided
10/11/2022
Date results information initially provided
23/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle and Wellbeing in NZ adults
Scientific title
An investigation into associations between diet and psychological distress in healthy NZ adults
Secondary ID [1] 305377 0
Nil known
Universal Trial Number (UTN)
U1111-1269-7112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet 323735 0
Psychological distress 323751 0
Stress resilience 323752 0
Condition category
Condition code
Diet and Nutrition 321263 321263 0 0
Other diet and nutrition disorders
Mental Health 321264 321264 0 0
Anxiety
Mental Health 321274 321274 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Self-reported data on dietary intake and habits, sleep, psychological distress, life stress, gender, age, physical activity, height, weight, social support, coping style and neighborhood socioeconomic status will be collected at one time point in an online survey.
Participants will access the survey through a link in email or via QR codes on posters. The approximate time needed to complete the survey is 30 minutes. No follow up with participants will occur. The study is in two parts, with sleep, exercise, stress and distress questions in part 1, and the food frequency questionnaire in the second part. Participants can opt to do both parts at the same time or to have the second part emailed to them to complete within a week. The participants will receive a $10 supermarket voucher for each part of the study which will be posted to them.
Intervention code [1] 321814 0
Not applicable
Comparator / control treatment
Participants with low life stress and low distress scores
Control group
Active

Outcomes
Primary outcome [1] 329065 0
Psychological distress score, measured using 12-item version of the General Health Questionnaire
Timepoint [1] 329065 0
At time of survey based on previous 7 days
Secondary outcome [1] 401335 0
Participants will record their usual dietary intake using a 70-item validated food frequency questionnaire (Sam et al., 2020).
Timepoint [1] 401335 0
Participants be asked to estimate frequency of food/s eaten over the 6 months prior to the survey.
Secondary outcome [2] 401336 0
Life stress as measured by score on Recent Life Changes Questionnaire (RLCQ), also known as the Holmes-Rahe stress inventory
Timepoint [2] 401336 0
Participants be asked to identify specific stressors from a list which have occurred in their life in the 6 months prior to the survey,
Secondary outcome [3] 415658 0
Estimated socioeconomic status based on the neighbourhood the participant lives in, Measured using the 2018 New Zealand Index of Multiple Deprivation. This is a coded value based on the participants address (the address details are not stored).
Timepoint [3] 415658 0
The participants address at time of survey.
Secondary outcome [4] 415659 0
Self reported sleep quality using the single-item sleep quality scale (SQS).
Timepoint [4] 415659 0
Sleep quality over the previous 7 days
Secondary outcome [5] 415660 0
Physical activity, measured using the New Zealand Physical Activity Questionnaire - short form (NZPAQ-SF), and quantified by using metabolic equivalent minutes per week (METS/wk)
Timepoint [5] 415660 0
Physical activity over the previous 7 days
Secondary outcome [6] 415661 0
Social Support, measured using the Multidimensional Scale of Perceived Social Support
Timepoint [6] 415661 0
Measured at the time of the survey
Secondary outcome [7] 415662 0
Approach coping, measured using the Brief Resilient
Coping Scale (BRCS)
Timepoint [7] 415662 0
At time of survey.
Secondary outcome [8] 415663 0
Body Mass Index calculated using participant reported height and weight
Timepoint [8] 415663 0
At time of survey
Secondary outcome [9] 415664 0
Anti-inflammatory diet index score
Timepoint [9] 415664 0
Based on food frequency over the previous 6 months

Eligibility
Key inclusion criteria
New Zealand Adults
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Dietary patterns will be identified using principal component analysis combined with cluster analysis. To investigate associations between diet quality and psychological distress dietary patterns, diet quality, and individual dietary components will be (separately) assessed against psychological distress (GHQ-12 scores) along with the covariates BMI, sleep quality, physical activity, estimated socioeconomic status (Index of Multiple Deprivation (IMD)), social support and coping style using multiple linear regression. To assess if relationships between diet and psychological distress are stronger under higher environmental stressors, or differ by gender, moderator analysis using linear regression will be undertaken. To determine any unique contribution of diet to psychological distress, these analyses will be repeated with stepwise multiple regression, controlling for the covariates. To investigate whether stress resilience is associated with differences in diet type or quality, participants will be grouped according to stress-resilience (see Table 2 in the attached study protocol), and diet quality and individual dietary components will be compared between groups using analysis of variance and multivariate analysis of variance respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/11/2022
Actual
14/11/2023
Date of last participant enrolment
Anticipated
31/05/2023
Actual
28/02/2024
Date of last data collection
Anticipated
30/06/2023
Actual
28/02/2024
Sample size
Target
180
Accrual to date
Final
199
Recruitment outside Australia
Country [1] 24149 0
New Zealand
State/province [1] 24149 0

Funding & Sponsors
Funding source category [1] 309746 0
Other Collaborative groups
Name [1] 309746 0
The Riddet Institute
Country [1] 309746 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Plant & Food Research
Address
Plant & Food Research
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4410
Country
New Zealand
Secondary sponsor category [1] 313974 0
None
Name [1] 313974 0
Address [1] 313974 0
Country [1] 313974 0
Other collaborator category [1] 281995 0
University
Name [1] 281995 0
Massey University
Address [1] 281995 0
Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
New Zealand
Country [1] 281995 0
New Zealand
Other collaborator category [2] 282447 0
University
Name [2] 282447 0
Otago University
Address [2] 282447 0
362 Leith Street
Dunedin North
Dunedin 9016
Country [2] 282447 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309502 0
Human Disability Ethics Commitee Southern B
Ethics committee address [1] 309502 0
hdecs@health.govt.nz
Ethics committee country [1] 309502 0
New Zealand
Date submitted for ethics approval [1] 309502 0
31/10/2022
Approval date [1] 309502 0
27/05/2023
Ethics approval number [1] 309502 0
2023 EXP 13347

Summary
Brief summary
There is emerging evidence that diet has an influence on depression, but our understanding of it is not yet well defined, and data in the New Zealand population is lacking. Stress is a variable which is rarely taken into account in research into diet and depression, and yet environmental stressors are a strong predictor of the development of episodes of major depressive disorder. Stress also affects food choices. The aim of this study is to assess whether different dietary factors in healthy adult New Zealanders aged between 18-45 years are associated with levels of psychological distress experienced with low or high levels of life stress. Co-variates sleep, exercise, a socioeconomic status proxy (neighborhood IMD deprivation index), social support and coping styles will also be measured. The study will provide baseline information from which more targeted research can be developed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114378 0
Ms Tracey Bear
Address 114378 0
Plant & Food Research
Private Bag 11600,
Palmerston North 4442, New Zealand
Country 114378 0
New Zealand
Phone 114378 0
+64 211702101
Fax 114378 0
Email 114378 0
tracey.bear@plantandfood.co.nz
Contact person for public queries
Name 114379 0
Ms Tracey Bear
Address 114379 0
Plant & Food Research
Private Bag 11600,
Palmerston North 4442, New Zealand
Country 114379 0
New Zealand
Phone 114379 0
+64 211702101
Fax 114379 0
Email 114379 0
tracey.bear@plantandfood.co.nz
Contact person for scientific queries
Name 114380 0
Ms Tracey Bear
Address 114380 0
Plant & Food Research
Private Bag 11600,
Palmerston North 4442, New Zealand
Country 114380 0
New Zealand
Phone 114380 0
+64 211702101
Fax 114380 0
Email 114380 0
tracey.bear@plantandfood.co.nz

Data sharing statement
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
13351Study protocol  tracey.bear@plantandfood.co.nz 382830-(Uploaded-08-11-2022-14-04-34)-Study-related document.pdf
13352Statistical analysis plan  tracey.bear@plantandfood.co.nz 382830-(Uploaded-31-10-2022-09-47-40)-Study-related document.pdf
13353Informed consent form  tracey.bear@plantandfood.co.nz 382830-(Uploaded-31-10-2022-10-04-51)-Study-related document.pdf
13354Ethical approval  tracey.bear@plantandfood.co.nz



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.