Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000772943
Ethics application status
Approved
Date submitted
3/06/2020
Date registered
28/07/2020
Date last updated
28/07/2020
Date data sharing statement initially provided
28/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an online healthy lifestyle behavioural modification intervention on cardiometabolic outcomes and affective symptoms in youth seeking treatment for mental health related issues.
Scientific title
The effect of an online healthy lifestyle behavioural modification intervention on cardiometabolic outcomes and affective symptoms in youth seeking treatment for mental health related issues.
Secondary ID [1] 301381 0
Nil known
Universal Trial Number (UTN)
U1111-1252-6304
Trial acronym
Online Healthy Lifestyle Behavioural Modification Intervention in Youth Mental Health (OHLBMIYMH)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
High blood pressure 317637 0
High fasting glucose levels 317968 0
Insulin resistance 317969 0
Overweight or obesity 317970 0
High blood cholesterol levels 317971 0
Sleep-wake disturbance 317972 0
Condition category
Condition code
Mental Health 315716 315716 0 0
Depression
Mental Health 315717 315717 0 0
Anxiety
Mental Health 315718 315718 0 0
Schizophrenia
Mental Health 315719 315719 0 0
Other mental health disorders
Diet and Nutrition 316004 316004 0 0
Obesity
Public Health 316005 316005 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research study investigates an online healthy lifestyle behavioural modification intervention and the associated changes in cardiometabolic risk parameters and mental health symptoms in young people seeking treatment for mental health related issues. All participants will engage in an online 12-week self-paced healthy lifestyle behavioural modification intervention program delivered by a mental health professional. This will involve structured nutrition, physical activity, sleep-wake and healthy lifestyle advice delivered fortnightly over 6 x 1 hour online workshops (week 1, 3, 5, 7, 9, and 11). During this time, participants will be asked to wear an actigraphy watch to detect body movement on the non-dominant wrist intermittently throughout the study. Two-week actigraphy recordings will be collected during weeks 1-2, 6-7 and 10-12 via an actigraphy device. Blood tests and anthropometric assessments (blood pressure, height, weight and waist circumference) will be conducted by the patients GP in week 1 and 12. Participants will also complete a set of self-report questionnaires in week 1 and 12. Clinician administered assessments will be conducted by mental health professionals (clinical psychologists, psychatrists, registered psychologists or clinical research staff) in weeks 1 and 12. The online psychoeducation sessions will cover the following learning outcomes.

• Session 1 (Week 1)- Brain and Body Connection
o How the brain and body are related to each other
o Establishing a healthy mindset
• Session 2 (Week 3)- Body Clock and Sleep-Wake Cycle Regulation
o Importance of the Brain and Body Clock and Sleep-Wake Cycle Regulation
o How the brain and body clock coordinates all the biological systems
o Healthy sleep-wake behaviours
o How lifestyle factors and behaviours influence the brain and body clock e.g. exercise, light exposure, sleep environment, sleep regularisation, naps, foods, stress, anxiety, mood.
• Session 3 (Week 5)-Physical activity for mental health (part 1)
o Benefits of physical activity for physical and mental health?
o Outline of Australian Physical Activity Guidelines?
o Barriers to engaging in physical activity
o Increasing incidental activity, reducing sitting time
• Session 4 (Week 7)- Physical activity for mental health (part 2)
o Working out anywhere
o Finding the motivation
o Concept of energy in vs energy out
• Session 5 (Week 9)- Nutrition for mental health (part 1)
o Energy in vs energy out and introducing the concept of a calorie
o Outline of Australian Dietary Guidelines
o Standard serving sizes/portion sizes
• Session 6 (Week 11)- Nutrition for mental health (part 2)
o Timing of meals
o Snacking
o Meal preparation
o Making healthy choices when eating out at restaurants
o Managing comfort eating.
These will be delivered entirely online via a series of educational videos. There will be weekly emails given to the participants with the links to the educational material where we will be able to determine their attendance.
Intervention code [1] 317685 0
Lifestyle
Intervention code [2] 317686 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323927 0
Insulin Resistance calculated by the HOMA2-IR formula- using fasting glucose and insulin measurements. The HOMA2-IR is the updated homeostatic model assessment (HOMA2-IR) using iHOMA2 software V.8.8. (Source: Hill, N.R., J.C. Levy, and D.R. Matthews, Expansion of the homeostasis model assessment of ß-cell function and insulin resistance to enable clinical trial outcome modeling through the interactive adjustment of physiology and treatment effects: iHOMA2. Diabetes care, 2013. 36(8): p. 2324-2330.)
Timepoint [1] 323927 0
Baseline (week 1) and Week 12.
Secondary outcome [1] 383353 0
Sleep-wake times assessed via actigraphy analysis
Timepoint [1] 383353 0
Weeks 1-2, 6-7 and 10-12
Secondary outcome [2] 384056 0
Physical activity levels assessed subjectively via the Simple Physical Activity Questionnaire (SIMPAQ)
Timepoint [2] 384056 0
Baseline (week 1) and week 12.
Secondary outcome [3] 384057 0
Physical activity levels assessed subjectively via the International Physical Activity Questionnaire (IPAQ).
Timepoint [3] 384057 0
Baseline and Week 12
Secondary outcome [4] 384058 0
Psychiatric severity measured by the clinician administers Brief Psychiatric Rating Scale (BPRS)
Timepoint [4] 384058 0
Baseline and Week 12
Secondary outcome [5] 384059 0
Level of psychiatric stage measured via clinician rated Clinical Staging Model, Trajectories (Tripartite Model)
Timepoint [5] 384059 0
Baseline and Week 12
Secondary outcome [6] 384060 0
Mania symptoms measures via clinician rated Young Mania Rating Scale (YMRS)
Timepoint [6] 384060 0
Baseline and Week 12
Secondary outcome [7] 384061 0
Level of psychological distress measures via self reported Kessler Psychological Distress Scale (K-10)
Timepoint [7] 384061 0
Baseline and Week 12
Secondary outcome [8] 384062 0
Psychological functioning measured via the self reported Somatic and Psychological Health Report (SPHERE 12)
Timepoint [8] 384062 0
Baseline and Week 12
Secondary outcome [9] 384063 0
Sleep quality measures via the self-reported Pittsberg Sleep Quality Index (PSQI)
Timepoint [9] 384063 0
Baseline and Week 12
Secondary outcome [10] 384064 0
Insomnia severity measured via the self-reported The Insomnia Severity Index (ISI)
Timepoint [10] 384064 0
Baseline and Week 12
Secondary outcome [11] 384065 0
Suicidal ideation measured via the self-reported Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [11] 384065 0
Baseline and Week 12
Secondary outcome [12] 384066 0
Depressive symptoms measured via the self-reported Quick Inventory of Depressive Symptomatology – self-report (QIDS-SR)
Timepoint [12] 384066 0
Baseline and Week 12
Secondary outcome [13] 384067 0
Anxiety symptoms measures via the self-reported Overall Anxiety Severity Impairment Scale (OASIS)
Timepoint [13] 384067 0
Baseline and Week 12
Secondary outcome [14] 384068 0
Substance usage measured via the self-reported World Health Organisation (WHO) Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST)
Timepoint [14] 384068 0
Baseline and Week 12
Secondary outcome [15] 384069 0
Alcohol use measured via the self-reported Alcohol Use Disorders Identification Test – Consumption (AUDIT-C)
Timepoint [15] 384069 0
Baseline and Week 12
Secondary outcome [16] 384070 0
Eating disorder symptoms mesures via the self-reported Eating Disorder Examination (EDE)
Timepoint [16] 384070 0
Baseline and Week 12
Secondary outcome [17] 384071 0
Ability to function in daily life assessed by self-reported Social and Occupational Assessment Scale (SOFAS)
Timepoint [17] 384071 0
Baseline and Week 12
Secondary outcome [18] 384072 0
Self-esteem measured via the self-reported Rosenberg Self-Esteem Scale (RSES).
Timepoint [18] 384072 0
Baseline and Week 12
Secondary outcome [19] 384189 0
Level of satisfaction with care measured via the self-reported Client Satisfaction Questionnaire-8 (CSQ-8) Client Satisfaction Questionnaire.
Timepoint [19] 384189 0
Week 12
Secondary outcome [20] 384190 0
Feasibility of the psychoeducation program measured via our team researcher developed self-report Feedback Questionnaire.
Timepoint [20] 384190 0
Week 12
Secondary outcome [21] 384887 0
Physical activity levels assessed via actigraphy analysis
Timepoint [21] 384887 0
Weeks 1-2, 6-7 and 10-12

Eligibility
Key inclusion criteria
• Aged between 16 and 30
• Youth seeking treatment for mental health related issues at one of the participating sites.
• BMI >25
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current diagnosis or history of an eating disorder (via the Structured Clinical Interview for DSM-5 Axis I Disorders (SCID)[3])
• Intellectual disability (at investigator’s discretion);
• Major neurological disorder, medical illness which impacts on cognition, and/or a history of sustained head injury;
• Not fluent in English
• An acute psychotic or manic episode that impairs the individual’s ability to give informed consent and/or requires acute clinical treatment;

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)
Methods used to generate the sequence in which subjects will be randomised (sequence 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
Correlations and change in mean scores for all of the cardiometabolic and affective measures will be obtained after completion of the 12-week online program via a paired samples t-test with significance levels set as less than 0.05. Pearson’s or Spearman’s correlations will be selected based on normative or non-normative data distribution, with significance levels set at less than 0.05. Correlations will be performed between other change scores to assess secondary endpoints using the same methodology.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2020
Actual
Date of last participant enrolment
Anticipated
1/09/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16781 0
Brain and Mind Centre - University of Sydney - Camperdown
Recruitment hospital [2] 16782 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 30404 0
2050 - Camperdown
Recruitment postcode(s) [2] 30405 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 305821 0
Other
Name [1] 305821 0
This study is an investigator-initiated trial funded by several philanthropic funding sources who choose to remain anonymous.
Country [1] 305821 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Research Portfolio, Office of Deputy Vice Chancellor Research
Level 3, Administration Building (F23), University of Sydney, NSW, 2006.
Country
Australia
Secondary sponsor category [1] 306290 0
None
Name [1] 306290 0
Address [1] 306290 0
Country [1] 306290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306089 0
Sydney Local Health District Human Research Ethics Review Committee- RPAH Zone
Ethics committee address [1] 306089 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 306089 0
Australia
Date submitted for ethics approval [1] 306089 0
25/05/2020
Approval date [1] 306089 0
27/07/2020
Ethics approval number [1] 306089 0
X20-0228 & 2020/ETH01201

Summary
Brief summary
This research study investigates an online healthy lifestyle behavioural modification intervention and the associated changes in cardiometabolic risk parameters and mental health symptoms in young people seeking treatment for mental health related issues. All participants will engage in an online 12-week self-paced healthy lifestyle behavioural modification intervention program. This will involve structured nutrition, physical activity, sleep-wake and healthy lifestyle advice delivered fortnightly over 6 online workshops (week 1, 3, 5, 7, 9, and 11). During this time, participants will be asked to wear an actigraphy watch to detect body movement on the non-dominant wrist intermittently throughout the study. Two-week actigraphy recordings will be collected during weeks 1-2, 6-7 and 10-12. Blood tests, anthropometric assessments (blood pressure, height, weight and waist circumference), self-report questionnaires and clinician administered assessments will be conducted in weeks 1 and 12.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102662 0
Prof Ian Hickie
Address 102662 0
Brain and Mind Centre, Building F, Level 4, 94 Mallett Street Camperdown, NSW, 2050
Country 102662 0
Australia
Phone 102662 0
+61438810231
Fax 102662 0
Email 102662 0
[email protected]
Contact person for public queries
Name 102663 0
Miss Chloe Wilson
Address 102663 0
Brain and Mind Centre
Level 2/97 Church St,
Camperdown NSW 2050
University of Sydney
Country 102663 0
Australia
Phone 102663 0
+61293510710
Fax 102663 0
Email 102663 0
[email protected]
Contact person for scientific queries
Name 102664 0
Miss Chloe Wilson
Address 102664 0
Brain and Mind Centre
Level 2/97 Church St,
Camperdown NSW 2050
University of Sydney
Country 102664 0
Australia
Phone 102664 0
+61293510710
Fax 102664 0
Email 102664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individuals will not be named in any reports or publications resulting from the study, and no document containing identifying information will leave the study site. Any publications based on the study will include only pooled results from participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8150Ethical approval    Ethical approval will be supplied once it is appro... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of an online healthy lifestyle psychoeducation programme to improve cardiometabolic outcomes and affective symptoms in youth receiving mental health care: study protocol for a pilot clinical trial.2021https://dx.doi.org/10.1136/bmjopen-2020-044977
N.B. These documents automatically identified may not have been verified by the study sponsor.