Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001238167
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
6/09/2019
Date last updated
18/03/2020
Date data sharing statement initially provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Coach-led vs self-directed habit-based interventions for weight loss in adults with overweight and obesity: a randomised controlled trial
Scientific title
Coach-led vs self-directed habit-based interventions for weight loss in adults with overweight and obesity: a randomised controlled trial
Secondary ID [1] 297864 0
Nil
Universal Trial Number (UTN)
U1111-1231-0198
Trial acronym
HBIT (Habit-Based Intervention Trial)
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
obesity 312236 0
overweight 312237 0
well-being 312238 0
Condition category
Condition code
Public Health 310781 310781 0 0
Health promotion/education
Diet and Nutrition 310782 310782 0 0
Obesity
Public Health 310783 310783 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sum Sanos, is a 12-month, one-on-one coach-led, habit-based weight loss program. Health coaches meet face-to-face with participants (or video call if face-to-face is not feasible) on a monthly basis for a 1 hour conversation, and follow-up with them via a 10-minute phone call on a weekly basis. The frequency of these follow-ups is aimed to establish accountability, support and maintain engagement in the program. The methodologies that form the foundation of Sum Sanos are based on evidence of key weight-loss facilitators; these topics are covered as a module during the monthly sessions (i.e., habit-change, self-compassion, mindful eating, setback strategies, etc.).

Participants are asked to track their daily habits using a ticksheet. This will be collected by the research assistants to assess adherence. Additionally, the number of monthly coach sessions and weekly phone calls attended will be recorded by the coach. Although there is no specific measure of fidelity, part of the coach's role is to help the participant maintain accuracy and consistency of the intervention.
Intervention code [1] 314096 0
Lifestyle
Intervention code [2] 314097 0
Behaviour
Intervention code [3] 315277 0
Treatment: Other
Comparator / control treatment
1. Seven Savvy Habits Booklet (7SH-B), is a program which aims to increase habitual performance of 7 proven weight management strategies including: (1) checking in with hunger, (2) drinking water before meals, (3) reducing intake of sugar-sweetened beverages, (4) keeping active for 30 minutes a day, (5) increasing protein intake, (6) practicing good sleep hygiene for better quality and quantity of sleep and (7) self-monitoring. The habits are presented in the form of a booklet, and a tracking diary is provided for self-monitoring of the habits. Participants are required to try to perform as many of the 7 habits as they can, everyday for 12-months. They will receive multiple 10-15-minute follow-up phone calls by a member of the research team (who is a dietitian and senior research fellow) to help support them on the program; these phone calls will be fortnightly for the first 3 months and every 3 months after that (at 6, 9 and 12 months).

2. Seven Savvy Habits App (7SH-A), presents the same 7 proven weight management strategies, but the habits are presented via a smartphone application, instead of a booklet. The tracking diary for self-monitoring of the habits is embedded within the app. Participants are required to try to perform as many of the 7 habits as they can, everyday for 12-months. They will receive multiple 10-15-minute follow-up phone calls by a member of the research team (who is a dietitian and senior research fellow) to help support them on the program; these phone calls will be fortnightly for the first 3 months and every 3 months after that (at 6, 9 and 12 months).

The 7SH intervention was developed by Dr Gina Cleo, Senior Researcher and Dietitian, from the Institute of Evidence-Based Healthcare, Bond University.
Control group
Active

Outcomes
Primary outcome [1] 319631 0
Weight change (kg) as assessed by digital scale.
Timepoint [1] 319631 0
12-months from intervention commencement
Secondary outcome [1] 368935 0
Weight change (kg) as assessed by digital scale.
Timepoint [1] 368935 0
3, 6, and 24 months
Secondary outcome [2] 368937 0
Fruit and vegetable consumption as assessed by self-reported typical daily intake: "On average, how many serves of fruit and vegetables do you eat a day?". A 'serve' of fruit and vegetable is described.
Timepoint [2] 368937 0
3, 6, 12 and 24 months
Secondary outcome [3] 368938 0
Physical activity levels as assessed by self-reported 7-day recall - a questionnaire designed specifically for this study.
Timepoint [3] 368938 0
3, 6, 12 and 24 months
Secondary outcome [4] 368939 0
Blood pressure as assessed by digital bench-top sphygmomanometer
Timepoint [4] 368939 0
3, 6, 12 and 24 months
Secondary outcome [5] 369889 0
Waist circumference (cm) as assessed by soft tape measure
Timepoint [5] 369889 0
3, 6, 12 and 24 months
Secondary outcome [6] 369890 0
Health-related quality of life as assessed by Short Form 12 (SF-12) Health Survey
Timepoint [6] 369890 0
3, 6, 12 and 24 months
Secondary outcome [7] 369891 0
Habit-strength as assessed by Creature of Habit Scale (COHS) and Self-Reported Behavioural Automaticity Index (SRBAI)
Timepoint [7] 369891 0
3, 6, 12 and 24 months
Secondary outcome [8] 369892 0
Self-regulation of eating as assessed by Self-Regulation of Eating Behaviour Questionnaire (SREBQ)
Timepoint [8] 369892 0
3, 6, 12 and 24 months
Secondary outcome [9] 369894 0
Temperament as assessed by the Effortful Control Scale (EC).
Timepoint [9] 369894 0
3, 6, 12 and 24 months
Secondary outcome [10] 369895 0
Number of coach follow-ups as assessed by a study-specific questionnaire, which is completed by the coach of the participant.
Timepoint [10] 369895 0
12-months from intervention commencement

Eligibility
Key inclusion criteria
Aged between 18 and 65 years, have a BMI greater than or equal to 27.0kg/m2, own a smartphone, able to consent for themselves and able to attend all required appointments during the intervention period. Participants will be recruited regardless of obesity-related comorbidities (e.g., cardiovascular disease and diabetes).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are pregnant, significantly ill, participating in other weight management programs, expecting to have bariatric surgery in the following 24-months, or taking medications affecting appetite, metabolism or weight.

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)
The Investigators will randomise participants into one of the three study arms using the clinical trial management software package, MASCoT (https://mascot.org.au). Participants will be informed of their allocation during their baseline appointment (after data collection) by the Investigator.

Trial participants and the Chief Investigator will not be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation randomisation will occur after baseline assessment to allocate participants to either Sum Sanos, 7SH booklet or 7SH app (allocation ratio 1:1:1). Participants will be informed of their study group allocation during the baseline appointment by the Chief Investigator. We will use minimization stratified on, BMI categories (overweight, obese class I, II, III), age (18-30, 31-43, 44-56, 57-65 years); and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Outcome assessors (research assistants/nurses) and data analysts will be blinded to group allocation.

Participants randomised to Sum Sanos, will be distributed to Life in Balance Pty Ltd (the parent company of Sum Sanos), to assign each participant with a health coach and commence the intervention.

Participants randomised to the 7SH booklet and 7SH app groups, will be managed through the central research centre at Bond University.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of covariance (ANCOVA) will be used for analysis of pre-post continuous measures collected during the study. For the primary outcome of change in weight at 12 months we will use linear regression to compare change in weight from baseline to 12 months with adjustment for baseline weight. We will use a type 3 analysis of effects to test the null hypothesis of no difference between the 3 treatment groups. If there is evidence of a difference (P<0.05), further pairwise comparisons between groups will be undertaken. Similar analyses will be undertaken for other continuous pre-post outcomes. Treatment effects will be reported as mean differences with 95% confidence intervals.

We plan to finalise and publish a detailed statistical analysis plan (SAP) prior to completion of data collection and before any statistical analysis is undertaken.

Additional analyses: In addition to the primary analysis outlined above we will conduct an adjusted analysis of the primary outcome to assess the impact of any potential baseline imbalances between treatment groups that may have occurred by chance. Variables to be included as covariates for this analysis include treatment site (included as indicator variables), gender and age. BMI will not be included as it is highly correlated with baseline weight which is already included in the ANCOVA regression model.

Handling missing data: We will use intention-to-treat analysis as our primary method. To account for missing primary outcome data, we will implement multiple imputation. In an additional analysis of the primary outcome we will use a per-protocol strategy to compare treatment groups after excluding participants who did not follow the study protocol.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
5/03/2020
Date of last participant enrolment
Anticipated
8/05/2020
Actual
Date of last data collection
Anticipated
13/05/2022
Actual
Sample size
Target
138
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302387 0
Government body
Name [1] 302387 0
Australian Commonwealth Government Innovation Connections Grant
Country [1] 302387 0
Australia
Funding source category [2] 302392 0
Commercial sector/Industry
Name [2] 302392 0
Life in Balance Seminars Pty Ltd
Country [2] 302392 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Bond University
14 University Dr
ROBINA QLD 4226
Country
Australia
Secondary sponsor category [1] 302283 0
None
Name [1] 302283 0
Address [1] 302283 0
Country [1] 302283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303060 0
Bond University Human Research Ethics Committee (BUHREC)
Ethics committee address [1] 303060 0
Bond University
14 University Dr
ROBINA QLD 4226
Ethics committee country [1] 303060 0
Australia
Date submitted for ethics approval [1] 303060 0
14/03/2019
Approval date [1] 303060 0
28/05/2019
Ethics approval number [1] 303060 0
GC02670

Summary
Brief summary
The purpose of this trial is to assess the effectiveness of a coach-supported (Sum Sanos) compared with two self-directed (7SH booklet and app) habit-based interventions on 12-month weight loss outcomes in adults with overweight or obesity.

Sum Sanos, is a 12-month, one-on-one coach-led, weight loss program. The methodologies that form the foundation of Sum Sanos are based on evidence of key weight-loss facilitators (i.e., habit-change, self-compassion, mindful eating, emotional management, etc.). (www.sumsanos.com)

Seven Savvy Habits (7SH), is a one-off self-guided booklet or smartphone application which the participants will engage in 12-months. 7SH is focused on making simple, evidence-based, weight management behaviours, habitual.

We hypothesise that a coach-supported intervention will be superior for weight loss outcomes compared with a self-directed approach
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92322 0
Dr Gina Cleo
Address 92322 0
Bond University
14 University Dr
ROBINA QLD 4226
Country 92322 0
Australia
Phone 92322 0
+61432688101
Fax 92322 0
Email 92322 0
gcleo@bond.edu.au
Contact person for public queries
Name 92323 0
Dr Gina Cleo
Address 92323 0
Bond University
14 University Dr
ROBINA QLD 4226
Country 92323 0
Australia
Phone 92323 0
+61432688101
Fax 92323 0
Email 92323 0
gcleo@bond.edu.au
Contact person for scientific queries
Name 92324 0
Dr Gina Cleo
Address 92324 0
Bond University
14 University Dr
ROBINA QLD 4226
Country 92324 0
Australia
Phone 92324 0
+61432688101
Fax 92324 0
Email 92324 0
gcleo@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable/anonymised individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor,
Available for what types of analyses?
The expectations of use of this data must be in accordance with the Office of the Australian Information Commissioner, which encourages all entities to take a holistic approach to ensuring that their data use is reasonable and appropriate, compliant with the Privacy Act and considers ethical and social responsibilities
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1925Study protocol    377316-(Uploaded-17-03-2020-15-50-01)-Study-related document.pdf
1926Informed consent form    377316-(Uploaded-17-02-2020-17-36-06)-Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1925Study protocol    377316-(Uploaded-25-08-2020-12-07-10)-Study-related document.pdf
1926Informed consent form    377316-(Uploaded-25-08-2020-13-10-09)-Study-related document.pdf

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.