Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000458336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/08/2025
Date registered
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14/04/2026
Date last updated
Help: Date last updated
14/04/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/04/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Growing Minds Feeling Good – A healthy lifestyle program for young people taking psychotropic medications
Scientific title
Growing Minds Feeling Good – Feasibility and acceptability of a digital lifestyle intervention for young people taking psychotropic medications
Additional trial identifiers [1] 312450 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GMFG (Growing Minds Feeling Good)
Related trial records

Health condition
Health condition(s) studied:
Metabolic health for adolescents and individuals taking antipsychotics 334280 0
Mental Health 341333 0
Health literacy 341498 0
Depression 341499 0
Anxiety 341500 0
Bipolar disorder 341501 0
Psychosis 341502 0
Schizophrenia 341503 0
Personality disorder 341504 0
Post traumatic stress disorder 341505 0
Condition category
Condition code
Metabolic and Endocrine 330939 330939 0 0
Other metabolic disorders
Mental Health 337081 337081 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Growing Minds Feeling Good (GMFG) intervention is a 12-week digital lifestyle program for young people aged 13–24 taking psychotropic medications. The intervention consists of evidence-based modules covering nutrition, physical activity, sleep, and nicotine cessation, adapted from the Keeping the Body in Mind (KBIM) program (Curtis et al., 2024). Content is delivered via a microlearning platform as bite-sized, mobile-first digital modules, including short written articles, interactive activities (goal-setting exercises, self-monitoring tools, quizzes), infographics, and embedded links to supporting resources. The platform is accessible with one click and does not require app downloads or logins. The intervention content and delivery frequency have been refined based on results of a prior stakeholder consultation.
At baseline, participants complete validated assessment measures for each lifestyle risk factor with a trained research assistant. Participants receive simple feedback on their results, aligned to specific modules, indicating whether there may be room for improvement in each area. Feedback is guided by thresholds set by the authors of each measure and delivered in a strengths-based and recovery-oriented manner. The initial module focuses on goal setting, which participants use to plan their progression through the remaining modules. Participants decide the order in which they progress through different GMFG modules based on their personal preferences and priorities. Participants then complete the intervention over 12 weeks, with each weekly module designed to be completed in approximately 15–30 minutes. Additional optional activities and resources are available within each module. The intervention is self-directed, with clinical oversight provided by the research team.
A research team member conducts weekly check-ins with participants to ensure safety, monitor progress, and answer questions. Adherence to the intervention is monitored through: (1) platform analytics on the microlearning platform, which track module completion rates, time spent on content, and progression through the program; (2) weekly check-ins with a trained research assistant, during which participants are asked whether they have used the program that week and their estimated engagement time; and (3) study records tracking completion of assessment questionnaires at each timepoint (baseline, 12 weeks, 6 months) administered via UNSW REDCap.
Participants in the intervention group are assessed at baseline (t1 = Week 0), post-intervention (t2 = Week 12), and follow-up (t3 = 6 months). Cardiometabolic health data is collected from participants' routine clinical care appointments and self-reported via UNSW REDCap.
[1] Curtis et al., "Implementation of a lifestyle and life-skills intervention to prevent weight-gain and cardiometabolic abnormalities in young people with first-episode psychosis as part of routine care: The Keeping the Body in Mind program," Early Interv. Psychiatry, pp. 1–8, Feb. 2024.
Intervention code [1] 328953 0
Lifestyle
Description of the comparator or control
Control group: Participants in the wait-list control group will undergo the same assessments at baseline, at week 12, and at 6 months (timeframe aligned with the intervention group). Participants will not receive GMFG intervention in the first 6 months. After the third assessment, participants will have access to the GMFG intervention for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 338755 0
Recruitment rate: Proportion of eligible participants enrolled out of those approached. Pre-specified benchmark >60%.
Timepoint [1] 338755 0
Assessed continuously throughout the recruitment period and reported at study completion.
Primary outcome [2] 338756 0
Retention Rate: Proportion of participants completing assessments at each timepoint (baseline, 12 weeks, 6 months), reported separately for intervention and control groups. Pre-specified benchmarks: Retention rate >70% at 12 weeks, >60% at 6 months.
Timepoint [2] 338756 0
12 weeks and 6 months.
Primary outcome [3] 344605 0
Engagement: The composite measure comprises module completion rate (proportion of modules completed out of total distributed) and weekly check-in attendance rate. These measures are reported together as they collectively characterise participants' engagement with the intervention. Pre-specified benchmark: Module engagement >70% completion.
Timepoint [3] 344605 0
Assessed continuously over the 12-week intervention period (intervention group only).
Secondary outcome [1] 458575 0
Physical activity
Timepoint [1] 458575 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [2] 458674 0
Body weight in kg
Timepoint [2] 458674 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [3] 459773 0
Body mass index (BMI)
Timepoint [3] 459773 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [4] 459774 0
Waist circumference
Timepoint [4] 459774 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [5] 459775 0
Lifestyle behaviours
Timepoint [5] 459775 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [6] 459778 0
Food and nutrition literacy
Timepoint [6] 459778 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [7] 459779 0
Health-related knowledge and attitudes
Timepoint [7] 459779 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [8] 459782 0
Sleep quality
Timepoint [8] 459782 0
Baseline, 12 weeks, and 6 months.
Secondary outcome [9] 459783 0
Acceptability of the intervention (this is an additional primary outcome)
Timepoint [9] 459783 0
12 weeks (intervention group only).

Eligibility
Key inclusion criteria
• Aged 13 to 24 years of age
• Taking psychotropic medications (e.g., antipsychotics) that can result in weight gain and therefore have been scheduled health service clinic appointments to monitor physical health
• Are able to consent for themselves to participate in the study
• Are capable of understanding and completing the intervention on their own
Minimum age
13 Years
Maximum age
24 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Individuals already undertaking the Keeping the Body in Mind program or similar.
• Individuals who are unable to consent for and participate in the study on their own.
• Not proficient in English or unable to understand and effectively communicate in English.
• Child or young person who currently have or previously have been diagnosed with bulimia nervosa or anorexia nervosa.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:

The plan is to enrol 38 subjects to complete the trial (feasibility study). The nominated sample is based on past research - the main aim of the project is to investigate the feasibility/implementation of the intervention, and past research indicated that around 30 participants would be sufficient to evaluate feasibility of the program [1]. Interventions for antipsychotic-induced weight gain delivered to child or youth populations have variable attrition rates. These values may range from anywhere between 5 and 21% [2], [3]. A lifestyle intervention for overweight teenagers with depression had an attrition rate of 25% [4]. Thus, we accounted for a conservative 20% attrition in our sample size estimates. As a result, a total number of about 38 potential participants will be required to participate in the study, and approximately 50 participants from the target population will be approached, or until the target sample size is met.



Statistical analysis plan:

For qualitative data, data will be handled using reflexive thematic analysis. If possible data will be coded by two researchers independently and resolve conflicts through discussion and/or involving a third researcher.

For quantitative data, protocol compliance will be analysed using methods such as the instrumental variable method and/or missing-completely-at-random test to analyse the nature of the missing data, and missing data will be handled accordingly. ANCOVA or regression models involving the aforementioned primary and secondary outcomes (at T2 or T3), with treatment group allocation being the independent variable will be employed. Regressions will also be done to explore the effect of time on the treatment effect. If feasible, subgroup analysis will be used to explore whether the treatment effects vary significantly between subcategories of trial participants. This includes subgroup analysis of diagnoses and type of psychotropic medication taken. We will report the reasons for any withdrawal for each study group and compare the results qualitatively.



[1] F. S. Walburg, J. W. de Joode, H. E. Brandt, M. W. van Tulder, M. C. Adriaanse, and B. van Meijel, “Implementation of a lifestyle intervention for people with a severe mental illness (SMILE): a process evaluation,” BMC Health Serv. Res., vol. 22, no. 1, p. 27, Jan. 2022

[2] D. J. Klein, E. M. Cottingham, M. Sorter, B. A. Barton, and J. A. Morrison, “A randomized, double-blind, placebo-controlled trial of metformin treatment of weight gain associated with initiation of atypical antipsychotic therapy in children and adolescents,” Am. J. Psychiatry, vol. 163, no. 12, pp. 2072–2079, Dec. 2006.

[3] C. U. Correll et al., “Metformin add-on vs. antipsychotic switch vs. continued antipsychotic treatment plus healthy lifestyle education in overweight or obese youth with severe mental illness: Results from the IMPACT trial,” World Psychiatry, vol. 19, no. 1, pp. 69–80, Feb. 2020.

[4] E. Jelalian, B. Jandasek, J. C. Wolff, L. M. Seaboyer, R. N. Jones, and A. Spirito, “Cognitive-Behavioral Therapy Plus Healthy Lifestyle Enhancement for Depressed, Overweight/Obese Adolescents: Results of a Pilot Trial,” J. Clin. Child Adolesc. Psychol., vol. 48, no. sup1, pp. S24–S33, 2019.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316866 0
Government body
Name [1] 316866 0
NMHRC
Country [1] 316866 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 319107 0
None
Name [1] 319107 0
None
Address [1] 319107 0
Country [1] 319107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315625 0
The University of New South Wales Committee B
Ethics committee address [1] 315625 0
Ethics committee country [1] 315625 0
Australia
Date submitted for ethics approval [1] 315625 0
28/06/2024
Approval date [1] 315625 0
17/03/2025
Ethics approval number [1] 315625 0
iRECS6119

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

Contacts
Principal investigator
Name 135302 0
Prof Valsamma Eapen
Address 135302 0
Mental Health Centre Level 1, Liverpool Hospital 1 Elizabeth Street, Liverpool NSW 2170
Country 135302 0
Australia
Phone 135302 0
+61 2 96 164 205
Fax 135302 0
Email 135302 0
[email protected]
Contact person for public queries
Name 135303 0
Valsamma Eapen
Address 135303 0
Mental Health Centre Level 1, Liverpool Hospital 1 Elizabeth Street, Liverpool NSW 2170
Country 135303 0
Australia
Phone 135303 0
+61 2 96 164 205
Fax 135303 0
Email 135303 0
[email protected]
Contact person for scientific queries
Name 135304 0
Valsamma Eapen
Address 135304 0
Mental Health Centre Level 1, Liverpool Hospital 1 Elizabeth Street, Liverpool NSW 2170
Country 135304 0
Australia
Phone 135304 0
+61 2 96 164 205
Fax 135304 0
Email 135304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a small feasibility study (n=38) with a vulnerable population (young people on psychotropic medications), which makes individual participant data sharing problematic from both a privacy and re-identification standpoint. With a sample that small, particularly recruited from a specific service in Western Sydney, even de-identified data could potentially be re-identifiable.



What supporting documents are/will be available?

No Supporting Document Provided


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.