Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000304730
Ethics application status
Approved
Date submitted
10/02/2022
Date registered
17/02/2022
Date last updated
25/09/2023
Date data sharing statement initially provided
17/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of GROUPS 4 HEALTH on psychosocial barriers to health behaviour change and well-being among higher weight people
Scientific title
Effect of GROUPS 4 HEALTH on psychosocial barriers to health behaviour change and well-being among higher weight people
Secondary ID [1] 306395 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 325224 0
Mental Health 325225 0
Condition category
Condition code
Mental Health 322626 322626 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 322653 322653 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GROUPS FOR HEALTH (G4H) is a manualised psychotherapeutic group-based program, which is designed to improve health and well-being by increasing group-based belonging (Haslam et al., 2021a, 2021b). The G4H program was developed using social and clinical psychology research (Haslam et al., 2018) and has been evaluated and found to be efficacious in reducing depression, loneliness, and social anxiety in Phase I, II, and III trials (see Cruwys et al., 2021; Haslam et al., 2016, 2019).

The G4H program consists of 5 modules which are completed over 8 weeks. Modules 1 to 4 will be run weekly, and Module 5 is run 4 weeks later, allowing participants to apply the social plans developed in Module 4. Each module runs between 60 to 90 minutes and will be facilitated by two trained and supervised facilitators (i.e., psychology postgraduate students who are provisionally registered as psychologists). All modules will be run face-to-face in the Australian National University Psychology Clinic in groups of 5 to 8 participants.

In addition to the facilitator’s manual, the program is supported by a client workbook. The client workbook contains a summarised version of the facilitator’s manual highlighting the main activities and learning points for each session, and space for participants to complete in-session and homework activities. Homework activities provide an opportunity for participants to reflect on the module learnings and encourage participants to apply those learnings to their social networks and goals. For example, between Modules 1 and 2 participants will be asked to reflect on up to three challenging moments they have experienced in the past and how the people in their lives helped them or could have helped them overcome those challenges. Between Modules 4 and 5 participants will be asked to put their SMART plan in to action (which they develop during Module 4) and reflect on any barriers and successes they have in implementing their SMART plan in the weeks between Module 4 and 5. For all homework activities participants will be encouraged to write down their reflections in their workbook to discuss at the beginning of the next module.The amount of time participants spend on the homework activities will be at their discretion.

Treatment fidelity is assessed by weekly supervision from a registered psychologist, and a brief questionnaire completed by facilitators at the end of each session delivered. This requires facilitators to tick off session activities covered, rate alliance and rapport between participants and with facilitator, indicate the length of session, and rate session satisfaction and ease of delivery.

Module content is summarised below:

Module 1 involves discussion of the importance of groups for health and well-being. In Module 2 clients complete a ‘social identity map’, which helps them to visualise their social network and map out how important their groups are to them, how they feel about each of their groups, and how their groups interact. Module 3 focuses on helping clients to manage their groups and discusses strategies they can use to manage conflict and get the most out of their group memberships. In Module 4 clients make a plan to improve their social connectedness, which they can action in the 4 weeks between Module 4 and Module 5. In Module 5, clients evaluate their progress, troubleshoot any barriers they experienced, and re-evaluate their social network by completing another ‘social identity map’.

Citations for facilitator manual and client workbook:

Haslam, C., Cruwys, T., Bentley, S. V., Haslam, S. A., Dingle, G. A., & Jetten, J. (2021). GROUPS 4 HEALTH Facilitator Manual (version 4.0). Social Identity and Groups Network (SIGN), The University of Queensland, Australia.

Haslam, C., Cruwys, T., Bentley, S. V., Haslam, S. A., Dingle, G. A., & Jetten, J. (2021). GROUPS 4 HEALTH Workbook (version 4.0). Social Identity and Groups Network (SIGN), The University of Queensland, Australia.
Intervention code [1] 322831 0
Treatment: Other
Comparator / control treatment
Non-randomised matched comparison group of people with a BMI of 30+ who have not completed the Groups 4 Health intervention (i.e., treatment as usual). This non-randomised matched comparison group will be obtained from a separate larger longitudinal survey project, which has several key similarities to the current trial:
(1) Similar key eligibility criteria: participants must be 18+ years of age, have a BMI of 30+, and have sufficient English language skills to understand and participate in research.
(2) Intervals between survey waves that are similar to the intervals between baseline, post-intervention, and 2-month follow-up in this trial: Wave 2 will occur 2-months after Wave 1 (similar to the post-intervention survey), and Wave 3 will occur 2-months after Wave 2 (similar to the 2-month follow-up survey).
(3) The longitudinal survey project includes the same primary outcomes and many of the secondary outcomes for this trial, allowing comparisons between the intervention group and the non-randomised matched comparison group on key outcomes.
Control group
Active

Outcomes
Primary outcome [1] 330424 0
Loneliness, as measured using the 20-item Revised UCLA Loneliness Scale (Russell et al., 1980).
Timepoint [1] 330424 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Primary outcome [2] 330425 0
General mental well-being, as measured using the Short Warwick-Edinburgh Mental Well-being Scale (Stewart-Brown et al., 2009).
Timepoint [2] 330425 0
Baseline (screening survey), after each intervention session, and at 2-months post intervention completion.
Primary outcome [3] 330453 0
Loneliness, as measured using the 4-item Revised UCLA Loneliness Scale short form (Russell et al., 1980).
Timepoint [3] 330453 0
After intervention sessions 1, 2, 3, and 4.
Secondary outcome [1] 406154 0
Weight-related social support, as measured by the Weight-related Interactions Scale (WRIS; Rieger et al., 2021).
Timepoint [1] 406154 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [2] 406155 0
Disordered eating behaviour, as measured using the Eating Disorder Examination Questionnaire – Short (Gideon et al., 2016).
Timepoint [2] 406155 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [3] 406156 0
Self-efficacy for physical activity, as measured using the Self-efficacy for Physical Activity scale, 5 items (Marcus et al., 1992).
Timepoint [3] 406156 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [4] 406158 0
Collective efficacy of therapy group to achieve health goals, as measured using the two items from Delea et al. (2018) and Cruwys et al. (2020).
Timepoint [4] 406158 0
After each intervention session and at 2-months post intervention completion.
Secondary outcome [5] 406161 0
Self-esteem, as measured using the Single-item Self-esteem measure (Robins et al., 2001).
Timepoint [5] 406161 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [6] 406162 0
Social phobia, as measured using the Mini Social Phobia Inventory (Mini-SPIN; Connor et al., 2001).
Timepoint [6] 406162 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [7] 406163 0
Multiple group membership, as measured using the Exeter Identity Transition Scale (EXITS; Haslam et al., 2008).
Timepoint [7] 406163 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [8] 406164 0
Social identification with therapy group, as measured using the Single Item Social Identification Scale (SISI; Postmes et al., 2013)
Timepoint [8] 406164 0
After each intervention session and at 2-months post intervention completion.
Secondary outcome [9] 406165 0
Social identification with facilitators, as measured using the Single Item Social Identification Scale (SISI; Postmes et al., 2013).
Timepoint [9] 406165 0
After each intervention session and at 2-months post intervention completion.
Secondary outcome [10] 406166 0
Social identification with higher weight people, as measured using the Single Item Social Identification Scale (SISI; Postmes et al., 2013).
Timepoint [10] 406166 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [11] 406167 0
Internalised weight stigma, as measured using the Two-Factor Weight Bias Internalization Scale (WBIS-2F; Meadows & Higgs, 2019)
Timepoint [11] 406167 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [12] 406273 0
Self-efficacy to achieve health goals, as measured using the single self-efficacy item from Delea at al. (2018). This is a primary outcome.
Timepoint [12] 406273 0
Baseline (screening survey), after each intervention session, and at 2-months post intervention completion.
Secondary outcome [13] 406274 0
Self-efficacy for healthy eating, as measured using the Healthy Eating subscale from the Health Eating and Weight Self-efficacy scale (HEWSE; Wilson-Barlow et al., 2014).
Timepoint [13] 406274 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [14] 406275 0
Self-efficacy for weight management, as measured using the Healthy Weight subscale from the Health Eating and Weight Self-efficacy scale (HEWSE; Wilson-Barlow et al., 2014).
Timepoint [14] 406275 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [15] 406276 0
Depression symptoms, as measured using the Depression subscale of the DASS-21 (Henry & Crawford, 2005).
Timepoint [15] 406276 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.
Secondary outcome [16] 406277 0
Anxiety symptoms, as measured using the Anxiety subscale of the DASS-21 (Henry & Crawford, 2005).
Timepoint [16] 406277 0
Baseline (screening survey), on completion of the intervention (after intervention session 5), and at 2-months post intervention completion.

Eligibility
Key inclusion criteria
1) being 18+ years of age
2) BMI 30+
3) Having sufficient English language skills to understand and join in group discussions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Severe suicidal ideation (endorsement of item 9 on the Patient Health Questionnaire-9 (PHQ-9, which will be included in the screening questionnaire for screening purposes) will prompt follow-up risk assessment by a trained member of the research team)
2) Severe psychological symptoms (e.g., a current psychotic episode; a composite score above 5 on the PHQ-9)
3) Severe neurological conditions or intellectual impairment
4) Substance dependence or intoxication

Study design
Purpose of the study
Treatment
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
Recruitment plan: We plan to recruit an initial sample of 50 higher weight participants who meet eligibility criteria. To have 0.80 power to detect a medium effect size with an alpha level of 0.05, a minimum of N = 28 people would need to be retained for follow-up. Assuming 60% survival rates (like Haslam et al., 2016; although a more recent G4H RCT by Cruwys et al., 2021 reported 87% survival rates), we expect to retain 30 of the initial 50 participants at 2-month follow-up.

We also plan to include a non-randomised matched comparison group of N=50 participants, which will be obtained from a separate larger longitudinal survey project.

Statistical analysis plan: We plan to use mixed-effects analysis (or multi-level modelling) to examine change in the primary and secondary outcomes over the course of therapy and at 2-month follow-up, and differences between the intervention group and the non-randomised matched comparison group. This approach will allow us to statistically account for both the repeated measures component of the data and the clustering of participants within therapy groups.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
25/08/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
14/08/2023
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 36751 0
2600 - Canberra
Recruitment postcode(s) [2] 36752 0
2601 - Canberra

Funding & Sponsors
Funding source category [1] 310748 0
University
Name [1] 310748 0
Australian National University
Country [1] 310748 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Tegan Cruwys
Address
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 311972 0
Individual
Name [1] 311972 0
Associate Professor Elizabeth Rieger
Address [1] 311972 0
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country [1] 311972 0
Australia
Secondary sponsor category [2] 311973 0
Individual
Name [2] 311973 0
Associate Professor Paul Dugdale
Address [2] 311973 0
Medical School, Building 54, Mills Road, The Australian National University, Canberra ACT 2601
Country [2] 311973 0
Australia
Secondary sponsor category [3] 311974 0
Individual
Name [3] 311974 0
Dr Joanne Rathbone
Address [3] 311974 0
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country [3] 311974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310327 0
Australian National University Human Ethics Committee
Ethics committee address [1] 310327 0
Ethics committee country [1] 310327 0
Australia
Date submitted for ethics approval [1] 310327 0
06/03/2022
Approval date [1] 310327 0
26/04/2022
Ethics approval number [1] 310327 0
2022/132

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

Contacts
Principal investigator
Name 117254 0
A/Prof Tegan Cruwys
Address 117254 0
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country 117254 0
Australia
Phone 117254 0
+61 261255023
Fax 117254 0
Email 117254 0
[email protected]
Contact person for public queries
Name 117255 0
Tegan Cruwys
Address 117255 0
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country 117255 0
Australia
Phone 117255 0
+61 261255023
Fax 117255 0
Email 117255 0
[email protected]
Contact person for scientific queries
Name 117256 0
Tegan Cruwys
Address 117256 0
Research School of Psychology, Building 39, Science Road, The Australian National University, Canberra ACT 2601
Country 117256 0
Australia
Phone 117256 0
+61 261255023
Fax 117256 0
Email 117256 0
[email protected]

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 data underlying published results will be made available on public repositories that align with open science practices, such as the Open Science Framework. This de-identified data may also include minimal demographic information (i.e., age, gender, BMI). Participants will be informed about how their de-identified data will be shared and will be asked to provide consent.
When will data be available (start and end dates)?
Data will be made available immediately after publication of the aggregate results in a peer-reviewed journal. There is no determined end date.
Available to whom?
De-identified data will be available to anyone who wishes to conduct further analyses of the data.
Available for what types of analyses?
Any type of analyses.
How or where can data be obtained?
On the Open Science Framework website: https://osf.io/


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.