Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001270909
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
25/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
25/11/2020
Date results provided
25/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
An online behavioural intervention targeting dietary habits in adults who are overweight
Scientific title
A randomised controlled trial investigating the impact of online behavioural intervention on self-compassion, dietary intake, eating behaviour, depression, anxiety, and stress in adults with overweight and obesity: focus on self-compassion, goal-setting and self-monitoring
Secondary ID [1] 302126 0
Nil known
Universal Trial Number (UTN)
U1111-1257-3884
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 319120 0
Overweight 319556 0
Condition category
Condition code
Diet and Nutrition 317079 317079 0 0
Obesity
Public Health 317080 317080 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Online behavioural intervention with a focus on self-compassion, goal-setting and self-monitoring
Intervention Materials: An online application developed for goal-setting and self-monitoring, along with a website providing information on healthy eating (nutrition information), basic behaviour change techniques, and self-compassion. The basic behaviour change principles such as goal-setting, self-monitoring, problem-solving, and barrier identification to facilitate dietary changes were used for the development of the application. Participants were given access to the online application via email containing a web link (URL) to the application webpage, allowing them to create a personal account and password for using the online application. Research staff assisted participants with any query and issues raised during the accounts' set up. Participants were asked to bookmark the application webpage on their personal devices for easy access. The application also provided feedback on participants’ performance and sent email reminders. The nutrition information was based on the Australian Dietary Guidelines 2013 and self-compassion information was partially adapted from the advice and practices developed by Neff and Germer 2013 ( Neff, K. D., & Germer, C. K, 2013. A pilot study and randomized controlled trial of the mindful self-compassion program. Journal of Clinical Psychology, 6, 28–44.) The information was modified to be more relevant to maladaptive eating behaviour and dietary related psychological distress.
Duration: 12 weeks
Procedure: Participants then received an email with a link to the study website every four weeks. During the study, participants could contact the investigator by email for further clarification or guidance on all aspects of the study. Participants were advised to adopt two goals (one for nutrition and one for self-compassion) based on the monthly information they received and track their progress on these goals using the online application over the 12-week study period. A list of goal options was available on the website to guide participants in adopting goals.
Who delivers the intervention: Material developed by Two nutrition experts (university-qualified nutritionist) with more than 5yrs experience and one academic in psychology. One of the nutritionists provided feedback on participants' performance via email.
Mode of Delivery: online and email
Number times the intervention delivered: 3 emails each required about 20 minutes to review. Participants needed to meet their set goals and track them daily via an online application provided to them.
Duration of app use: approximately 5 minutes for the 12 weeks of the intervention
Location: Community setting in Australia
Adherence: was measured by the frequency of log-ins and goal achievements.
Intervention code [1] 318635 0
Behaviour
Intervention code [2] 318636 0
Lifestyle
Comparator / control treatment
Intervention: Nutrition Information in PDF format
The nutrition information provided to the control group was similar to the core part of the nutrition information provided to the intervention group. This group did not receive any information on goal-setting or self-compassion, nor did they have access to the study website or online Goal Tracker.
Procedure: Participants received an email with a PDF file (nutrition information) every four weeks.
Number times the intervention delivered: 3 emails each required about 20 minutes to review.
Duration: 12 weeks
Delivery: Email
Control group
Active

Outcomes
Primary outcome [1] 325170 0
Self-compassion by Self-compassion Scale (SCS)
Timepoint [1] 325170 0
Baseline and follow up at week 12
Primary outcome [2] 325537 0
Dietary intake by the self-administered automated 24-hour dietary recall (using Intake24 tool) and Healthy eating Quiz (HEQ)
Timepoint [2] 325537 0
Baseline and follow up at week 12
Primary outcome [3] 325538 0
Eating behaviour by Eating Disorder Examination Questionnaire (EDE-Q])
Timepoint [3] 325538 0
Baseline and follow up at week 12
Secondary outcome [1] 387078 0
self-reported body weight by weighing scales
Timepoint [1] 387078 0
Baseline and follow up at week 12
Secondary outcome [2] 388333 0
Mental wellbeing (Primary outcome) by Depression Anxiety and Stress Scale -21 (DASS-21)
Timepoint [2] 388333 0
Baseline and follow up at week 12
Secondary outcome [3] 388334 0
Self-reported body height by tape measures
Timepoint [3] 388334 0
Baseline and follow up at week 12
Secondary outcome [4] 388335 0
Body Mass Index calculated by self-reported body weight (kg) assessed by weighing scales divided by the square of the self-reported body height (m) assessed by tape measures
Timepoint [4] 388335 0
Baseline and follow up at week 12

Eligibility
Key inclusion criteria
• Aged 18 - 55 years
• Have a BMI 25 - 40 kg /m2
• Have access to a computer/tablet/smart phone that can run an internet browser for at least 1 hour per week
• Be able to read and write English
• Be open to changing what they eat and potentially losing weight.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a BMI > 40 kg / m2 or < 25 kg / m2
• Take any weight-loss medications (or have taken any weight-loss medications in the past 6 months) or currently use medication which has substantial weight gain as a common side effect e.g. >20mg of prednisolone (Medications with minor effects on body weight and appetites such as contraceptives and antidepressants are not considered as exclusion criteria).
• Suffer from any major medical illness or have a history of major medical illness (in the last 5 years). Major medical illness includes: heart attack, stroke or cancer; or any overt metabolic, respiratory or neurological disease
• Current pregnancy or lactationCurrently participating in any other nutrition or weight loss program (e.g. Michelle Bridges’ 12-week Body Transformation) or seeing a nutrition professional (e.g., a dietitian)
•Smoking
• Weight loss of more than 4.5 kg (10 pounds) during the past 6 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method of sealed envelopes suggested by Schulz and Grimes (2002) was used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence of 120 numbers (smallest value = 1, largest value = 120) was generated in two columns (60 each) using the online website Random.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: Power analysis was based on the effect size detected in an
initial pilot study for the primary outcome of self-compassion. The sample size was calculated to detect the effect size of Cohen's d=0.61 with the power of 80% and confidence interval (CI) of 95%. A final sample size of 45 was needed in each group, which was increased by 30% to take attrition into account (i.e. total
sample of 120).
Statistical analysis: To compare between-group differences in outcome measures at baseline, the Pearson chi-square test was carried out for categorical variables and independent t-test for continuous variables.
A series of 2 (time: pre- and post-intervention) x 2 (group: intervention and control) mixed analysis of variances (ANOVAs) were carried out to test whether the changes in pre- and post-intervention values differ between two groups.
All statistical tests were two-tailed and differences were considered to be statistically significant at p<0.05.
Outcomes were analysed using an ‘as treated’ (AT) approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
15/03/2018
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
120
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306552 0
Self funded/Unfunded
Name [1] 306552 0
Country [1] 306552 0
Primary sponsor type
University
Name
University of New South Wales
Address
High St, University of New South Wales, Kensington NSW, 2052
Country
Australia
Secondary sponsor category [1] 307658 0
Individual
Name [1] 307658 0
Hania Rahimi Ardabili
Address [1] 307658 0
Samuels Building (F25), University of New South Wales, Kensington NSW, 2033
Country [1] 307658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306742 0
UNSW Human Research Ethics
Ethics committee address [1] 306742 0
Ethics committee country [1] 306742 0
Australia
Date submitted for ethics approval [1] 306742 0
26/10/2016
Approval date [1] 306742 0
15/02/2017
Ethics approval number [1] 306742 0
HC16879

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

Contacts
Principal investigator
Name 104866 0
Dr Hania Rahimi-Ardabili
Address 104866 0
Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 104866 0
Australia
Phone 104866 0
+61 2 9385 1501
Fax 104866 0
Email 104866 0
[email protected]
Contact person for public queries
Name 104867 0
Hania Rahimi-Ardabili
Address 104867 0
Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 104867 0
Australia
Phone 104867 0
+61 2 9385 1501
Fax 104867 0
Email 104867 0
[email protected]
Contact person for scientific queries
Name 104868 0
Hania Rahimi-Ardabili
Address 104868 0
Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 104868 0
Australia
Phone 104868 0
+61 2 9385 1501
Fax 104868 0
Email 104868 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
According to the Ethics protocol, individual participant data from this study will not be shared with anyone except for the study investigators.


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.