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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]

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

High fasting glucose levels

Insulin resistance

Overweight or obesity

High blood cholesterol levels

Sleep-wake disturbance

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Schizophrenia

Mental Health

Other mental health disorders

Diet and Nutrition

Obesity

Public Health

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]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline (week 1) and Week 12.

Secondary outcome [1]

Sleep-wake times assessed via actigraphy analysis

Timepoint [1]

Weeks 1-2, 6-7 and 10-12

Secondary outcome [2]

Physical activity levels assessed subjectively via the Simple Physical Activity Questionnaire (SIMPAQ)

Timepoint [2]

Baseline (week 1) and week 12.

Secondary outcome [3]

Physical activity levels assessed subjectively via the International Physical Activity Questionnaire (IPAQ).

Timepoint [3]

Baseline and Week 12

Secondary outcome [4]

Psychiatric severity measured by the clinician administers Brief Psychiatric Rating Scale (BPRS)

Timepoint [4]

Baseline and Week 12

Secondary outcome [5]

Level of psychiatric stage measured via clinician rated Clinical Staging Model, Trajectories (Tripartite Model)

Timepoint [5]

Baseline and Week 12

Secondary outcome [6]

Mania symptoms measures via clinician rated Young Mania Rating Scale (YMRS)

Timepoint [6]

Baseline and Week 12

Secondary outcome [7]

Level of psychological distress measures via self reported Kessler Psychological Distress Scale (K-10)

Timepoint [7]

Baseline and Week 12

Secondary outcome [8]

Psychological functioning measured via the self reported Somatic and Psychological Health Report (SPHERE 12)

Timepoint [8]

Baseline and Week 12

Secondary outcome [9]

Sleep quality measures via the self-reported Pittsberg Sleep Quality Index (PSQI)

Timepoint [9]

Baseline and Week 12

Secondary outcome [10]

Insomnia severity measured via the self-reported The Insomnia Severity Index (ISI)

Timepoint [10]

Baseline and Week 12

Secondary outcome [11]

Suicidal ideation measured via the self-reported Suicidal Ideation Attributes Scale (SIDAS)

Timepoint [11]

Baseline and Week 12

Secondary outcome [12]

Depressive symptoms measured via the self-reported Quick Inventory of Depressive Symptomatology – self-report (QIDS-SR)

Timepoint [12]

Baseline and Week 12

Secondary outcome [13]

Anxiety symptoms measures via the self-reported Overall Anxiety Severity Impairment Scale (OASIS)

Timepoint [13]

Baseline and Week 12

Secondary outcome [14]

Substance usage measured via the self-reported World Health Organisation (WHO) Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST)

Timepoint [14]

Baseline and Week 12

Secondary outcome [15]

Alcohol use measured via the self-reported Alcohol Use Disorders Identification Test – Consumption (AUDIT-C)

Timepoint [15]

Baseline and Week 12

Secondary outcome [16]

Eating disorder symptoms mesures via the self-reported Eating Disorder Examination (EDE)

Timepoint [16]

Baseline and Week 12

Secondary outcome [17]

Ability to function in daily life assessed by self-reported Social and Occupational Assessment Scale (SOFAS)

Timepoint [17]

Baseline and Week 12

Secondary outcome [18]

Self-esteem measured via the self-reported Rosenberg Self-Esteem Scale (RSES).

Timepoint [18]

Baseline and Week 12

Secondary outcome [19]

Level of satisfaction with care measured via the self-reported Client Satisfaction Questionnaire-8 (CSQ-8) Client Satisfaction Questionnaire.

Timepoint [19]

Week 12

Secondary outcome [20]

Feasibility of the psychoeducation program measured via our team researcher developed self-report Feedback Questionnaire.

Timepoint [20]

Week 12

Secondary outcome [21]

Physical activity levels assessed via actigraphy analysis

Timepoint [21]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Brain and Mind Centre - University of Sydney - Camperdown

Recruitment hospital [2]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Other

Name [1]

This study is an investigator-initiated trial funded by several philanthropic funding sources who choose to remain anonymous.

Address [1]

This study is an investigator-initiated trial funded by several various philanthropic funding sources who choose to remain anonymous. We are therefore not in a position to give the details of the specific funding bodies.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Review Committee- RPAH Zone

Ethics committee address [1]

Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/05/2020

Approval date [1]

27/07/2020

Ethics approval number [1]

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

Prof Ian Hickie

Address

Brain and Mind Centre, Building F, Level 4, 94 Mallett Street Camperdown, NSW, 2050

Country

Australia

Phone

+61438810231

Fax

[email protected]

Contact person for public queries

Name

Chloe Wilson

Address

Brain and Mind Centre
Level 2/97 Church St,
Camperdown NSW 2050
University of Sydney

Country

Australia

Phone

+61293510710

Fax

[email protected]

Contact person for scientific queries

Name

Chloe Wilson

Address

Brain and Mind Centre
Level 2/97 Church St,
Camperdown NSW 2050
University of Sydney

Country

Australia

Phone

+61293510710

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
8150	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Effect 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.	2021	https://dx.doi.org/10.1136/bmjopen-2020-044977

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically