Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000580875
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
17/05/2021
Date last updated
24/01/2022
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-compassion for weight management: an online intervention for adults seeking to manage weight
Scientific title
Investigating the effect of an online supplemental self-compassion for weight management intervention (SC4WM) on participant self-compassion, eating behaviour, physical activity, and body weight in adults seeking to manage weight: A randomized-controlled trial
Secondary ID [1] 303766 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SC4WM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 321261 0
Condition category
Condition code
Diet and Nutrition 319038 319038 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-compassion for Weight Management (SC4WM) intervention
The 4-week SC4WM intervention is delivered online through a mobile-friendly website. Participants in the intervention group will be asked to follow the digital WW™ program+ SC4WM program. Participants will need to use data or internet connectivity and an SC4WM access code to log into the website content.

The SC4WM intervention incorporates simple, evidence-based techniques (e.g., journaling, letter writing, reflections) to deliver a SC intervention tailored to weight management outcomes (i.e, eating behaviour, physical activity, and weight monitoring).

The SC4WM intervention landing page (website) provides an initial definition and background on SC and quick access to each module. The SC4WM has four weekly modules designed to specifically target participants' relationship with each weight management outcome, including SC for eating behaviour, SC for physical activity, and SC for body weight. Each module includes a journal, meditation, and reflection activity incorporating the principles of SC to eating behaviour, physical activity behaviour, and body weight. The activities can be completed in approximately 20-30 minutes. It is recommended that participants complete one module in sequence per week, with the last week focused on bringing all of the modules together and incorporating SC4WM into their entire weight management journey.

Adherence to the SC4WM is measured by asking participants at 4 and 12-weeks how many modules they completed and how many days they engaged in the SC4WM activities. .

Participants in the intervention group have access to the WW™ program for a total of 12-weeks (4-weeks with the SC4WM program and 8-weeks on their own until the 3 month follow-up).

The WW™ program is an evidence-based widely available commercial weight management program that aims to support its members with developing healthier habits. The WW™ program uses the Smartpoints™ food tracking, which encourages healthier food choices by assigning point values to foods requiring moderation (e.g., higher fat and higher sugar foods). The WW™ program includes recommendations on exercising, fostering a positive mindset, and monitoring body weight with the objective of weight management. Participants in the intervention group are asked to follow the WW™ program as they like for 12-weeks.

Adherence to the WW™ is self-reported by participants at 4 and 12-weeks (e.g., Over the last 4-weeks how many days did you use the WW™ app or WW™ online program?).
Intervention code [1] 320080 0
Behaviour
Intervention code [2] 320081 0
Lifestyle
Comparator / control treatment
Control Group
Participants randomized to the control group will have 12-week access to the digital (100% online) WW™- Weight Watchers reimagined program. The WW™ program is an evidence-based behavioural weight management program that aims to support its members with healthier habits. The WW™ program uses the Smartpoints™ food tracking system, which nudges members to make healthier food choices by assigning point values to foods requiring moderation (e.g., higher fat and higher sugar foods). In addition, the WW™ program promotes exercising, cultivating a positive mindset, and tracking body weight with the objective of weight management.

The myWW™ program may contain elements of SC within its content, however, the SC4WM intervention is designed to have a more concentrated dose of SC.
Control group
Active

Outcomes
Primary outcome [1] 326947 0
Self-compassion -Self-compassion Scale (Neff, 2003)
Timepoint [1] 326947 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement (primary endpoint)
Secondary outcome [1] 393209 0
Eating behaviour, physical activity - The Weight Control Strategies Scale (WCSS) (Pinto, Fava, Raynor, LaRose, & Wing, 2013)
Timepoint [1] 393209 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [2] 393213 0
Height/Body weight (BMI Composite)

Participant self-report (online questionnaire)
Timepoint [2] 393213 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [3] 393215 0
Eating restraint- Revised Rigid Restraint Scale (RRRS) (Adams & Leary, 2007)
Timepoint [3] 393215 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [4] 393216 0
Weight self-stigma - Weight Self-Stigma Questionnaire (WSSQ) (Lillis, Luoma, Levin, & Hayes, 2012)
Timepoint [4] 393216 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [5] 393217 0
General stress - The Perceived Stress Scale (PSS) (Cohen, Kamarck, & Mermelstein, 1983)
Timepoint [5] 393217 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [6] 393218 0
Psychological coping -COPE (Carver, 1997); The Weight Control Strategies Scale (WCSS) (Pinto, Fava, Raynor, LaRose, & Wing, 2013)
Timepoint [6] 393218 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement
Secondary outcome [7] 393219 0
Emotional well-being - WHO-5 Well-being Scale (Bech, Olsen, Kjoller, & Rasmussen, 2003)
Timepoint [7] 393219 0
Baseline, 4 weeks post-intervention commencement, 8-weeks post-intervention commencement

Eligibility
Key inclusion criteria
1) Aged greater than or equal to 18 years and 2) seeking to manage weight.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Diagnosed eating disorder (Anorexia Nervosa, Bulimia Nervosa)
2) pregnant or expecting to be pregnant in the next 12-weeks
3) prescribed medication for weight loss or newly prescribed a medication that may cause weight change
4) current WW™ members are excluded.

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)
Allocation is not concealed.
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
Using SPSS software (version 27), data will be assessed for violations of the parametric assumptions. Generalised linear mixed models will be used to explore within and between-group differences in changes in the primary (SCS total) and secondary outcomes (eating behaviour, physical activity and body weight) at the 4-week follow-up, with random intercepts for participant to account for repeated measures. Primary and secondary outcomes will also be evaluated at a 12-week follow-up. Possible moderators of the relationship between the SC4WM intervention and changes in self-compassion (e.g. greater weight self-stigma WSSQ at baseline) and weight management outcomes at 4 and 12-weeks will be explored by adding an interaction term (e.g., WSSQ*group*time) to the linear mixed models.

Baseline differences between completers and non-completers in the intervention and control groups will be evaluated using independent sample t-tests. The analyses will be based on both intention-to-treat and Complier Average Causal Effect (CACE) analytic methods. CACE is preferred to per-protocol for this study as it recognises that different individuals may have different intervention needs (e.g., differing intervention doses which may be effective for each individual participant). CACE modelling considers intervention outcomes (µi) and proportion of the intervention participants completed (pi) in 4 cells defined by treatment use. The mean at each time point for the intervention and control group will be the average of µ1 = pcµc1 + pnµn2 + paµa3 + pdµd4. For example, mean self-compassion (SCS total) at each time point (e.g. 4 weeks from baseline and 12 weeks from baseline) for participants in the SC4WM intervention will be determined by grouping participants based on usage of the SC4WM intervention (e.g., 1 =completers, 2=half-completers, 3=minimal completers and 4= non-completers based on reported completion of models of the SC4WM intervention). The self-compassion means for those in the control group will be determined by grouping participants based on usage of the WW program (e.g., 1 =completers, 2=half-completers, 3=minimal completers and 4= non-completers based on reported usage of the WW program). Therefore, using CACE, the mean self-compassion score at each time point (e.g., post at 4-weeks from baseline and follow up, 12-weeks from baseline) for the intervention and control group will be the average of µ1 = pcµc1 + pnµn2 + paµa3 + pdµd4.

Participant open ended comments on their experience at 4 and 12-weeks will be analysed using directed content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
17/06/2021
Date of last participant enrolment
Anticipated
1/07/2021
Actual
30/06/2021
Date of last data collection
Anticipated
1/10/2021
Actual
11/10/2021
Sample size
Target
240
Accrual to date
Final
249
Recruitment outside Australia
Country [1] 23560 0
New Zealand
State/province [1] 23560 0

Funding & Sponsors
Funding source category [1] 308171 0
University
Name [1] 308171 0
University of Auckland
Country [1] 308171 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
22-30 Park Avenue, Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 308941 0
Commercial sector/Industry
Name [1] 308941 0
WW-Weight Wactchers reimagined
Address [1] 308941 0
675 Avenue OF The Americas FL 6
New York, NY, 10010-5117
Country [1] 308941 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308156 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 308156 0
Ethics committee country [1] 308156 0
New Zealand
Date submitted for ethics approval [1] 308156 0
15/02/2021
Approval date [1] 308156 0
12/03/2021
Ethics approval number [1] 308156 0
AH3409

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

Contacts
Principal investigator
Name 109730 0
Dr Anna Serlachius
Address 109730 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 109730 0
New Zealand
Phone 109730 0
+64 99233073
Fax 109730 0
Email 109730 0
[email protected]
Contact person for public queries
Name 109731 0
Jennifer Brenton-Peters
Address 109731 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 109731 0
New Zealand
Phone 109731 0
+64 226713224
Fax 109731 0
Email 109731 0
[email protected]
Contact person for scientific queries
Name 109732 0
Jennifer Brenton-Peters
Address 109732 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 109732 0
New Zealand
Phone 109732 0
+64 226713224
Fax 109732 0
Email 109732 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
Participants have not consented to sharing IPD.


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
SourceTitleYear of PublicationDOI
EmbaseInvestigating the effect of an online self-compassion for weight management (SC4WM) intervention on self-compassion, eating behaviour, physical activity and body weight in adults seeking to manage weight: Protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-056174
N.B. These documents automatically identified may not have been verified by the study sponsor.