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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
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Scientific title
Coach-led vs self-directed habit-based interventions for weight loss in adults with overweight and obesity: a randomised controlled trial
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Secondary ID [1]
297864
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Nil
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Universal Trial Number (UTN)
U1111-1231-0198
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Trial acronym
HBIT (Habit-Based Intervention Trial)
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Linked study record
not applicable
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Health condition
Health condition(s) or problem(s) studied:
obesity
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overweight
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well-being
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Condition category
Condition code
Public Health
310781
310781
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0
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Health promotion/education
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Diet and Nutrition
310782
310782
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0
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Obesity
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Public Health
310783
310783
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314096
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Lifestyle
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Intervention code [2]
314097
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Behaviour
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Intervention code [3]
315277
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Weight change (kg) as assessed by digital scale.
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Assessment method [1]
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Timepoint [1]
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12-months from intervention commencement
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Secondary outcome [1]
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Weight change (kg) as assessed by digital scale.
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Assessment method [1]
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Timepoint [1]
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3, 6, and 24 months
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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3, 6, 12 and 24 months
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Secondary outcome [3]
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Physical activity levels as assessed by self-reported 7-day recall - a questionnaire designed specifically for this study.
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Assessment method [3]
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Timepoint [3]
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3, 6, 12 and 24 months
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Secondary outcome [4]
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Blood pressure as assessed by digital bench-top sphygmomanometer
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Assessment method [4]
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Timepoint [4]
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3, 6, 12 and 24 months
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Secondary outcome [5]
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Waist circumference (cm) as assessed by soft tape measure
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Assessment method [5]
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Timepoint [5]
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3, 6, 12 and 24 months
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Secondary outcome [6]
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Health-related quality of life as assessed by Short Form 12 (SF-12) Health Survey
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Assessment method [6]
369890
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Timepoint [6]
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3, 6, 12 and 24 months
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Secondary outcome [7]
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Habit-strength as assessed by Creature of Habit Scale (COHS) and Self-Reported Behavioural Automaticity Index (SRBAI)
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Assessment method [7]
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Timepoint [7]
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3, 6, 12 and 24 months
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Secondary outcome [8]
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Self-regulation of eating as assessed by Self-Regulation of Eating Behaviour Questionnaire (SREBQ)
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Assessment method [8]
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Timepoint [8]
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3, 6, 12 and 24 months
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Secondary outcome [9]
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Temperament as assessed by the Effortful Control Scale (EC).
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Assessment method [9]
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Timepoint [9]
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3, 6, 12 and 24 months
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Secondary outcome [10]
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Number of coach follow-ups as assessed by a study-specific questionnaire, which is completed by the coach of the participant.
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Assessment method [10]
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Timepoint [10]
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12-months from intervention commencement
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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).
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/03/2020
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Actual
5/03/2020
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Date of last participant enrolment
Anticipated
8/05/2020
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Actual
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Date of last data collection
Anticipated
13/05/2022
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Actual
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Sample size
Target
138
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Accrual to date
60
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Commonwealth Government Innovation Connections Grant
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Address [1]
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Department of Industry, Innovation and Science
10 Binara Street CANBERRA ACT 2601
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Life in Balance Seminars Pty Ltd
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Address [2]
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427 South Road
BENTLEIGH VIC 3204
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Country [2]
302392
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Australia
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Primary sponsor type
University
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Name
Bond University
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Address
Bond University
14 University Dr
ROBINA QLD 4226
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302283
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Country [1]
302283
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bond University Human Research Ethics Committee (BUHREC)
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Ethics committee address [1]
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Bond University
14 University Dr
ROBINA QLD 4226
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Ethics committee country [1]
303060
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Australia
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Date submitted for ethics approval [1]
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14/03/2019
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Approval date [1]
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28/05/2019
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Ethics approval number [1]
303060
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GC02670
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gina Cleo
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Address
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Bond University
14 University Dr
ROBINA QLD 4226
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Country
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Australia
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Phone
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+61432688101
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Gina Cleo
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Address
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Bond University
14 University Dr
ROBINA QLD 4226
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Country
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Australia
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Phone
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+61432688101
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Gina Cleo
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Address
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Bond University
14 University Dr
ROBINA QLD 4226
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Country
92324
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Australia
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Phone
92324
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+61432688101
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Fax
92324
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Non-identifiable/anonymised individual participant data underlying published results
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When will data be available (start and end dates)?
Immediately following publication, no end date determined
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor,
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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
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1925
Study protocol
377316-(Uploaded-17-03-2020-15-50-01)-Study-related document.pdf
1926
Informed consent form
377316-(Uploaded-17-02-2020-17-36-06)-Study-related document.docx
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1925
Study protocol
377316-(Uploaded-25-08-2020-12-07-10)-Study-related document.pdf
1926
Informed 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.
Download to PDF