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Trial registered on ANZCTR


Registration number
ACTRN12619001088134p
Ethics application status
Submitted, not yet approved
Date submitted
24/06/2019
Date registered
7/08/2019
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes from a psycho-behavioural treatment for maintenance of weight loss.
Scientific title
Investigating moderators and mediators of outcomes in an open trial of a novel psycho-behavioural treatment for relapse prevention and maintenance of weight loss in people with high BMI treated for one year in a comprehensive behavioural weight loss medical clinic.
Secondary ID [1] 298582 0
Nill
Universal Trial Number (UTN)
U1111-1235-9047
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 313424 0
disordered eating 313425 0
overweight 313531 0
Condition category
Condition code
Mental Health 311859 311859 0 0
Eating disorders
Diet and Nutrition 311964 311964 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will be embedded in a large public hospital program at for people with moderate to severe obesity with medical complications, e.g. type 2 diabetes mellitus. This clinic provides a multidisciplinary medical and allied health review - dietetic, psychology, exercise physiology, physiotherapy. There is a mandatory intensive exercise program with on-site classes supervised by an exercise physiologist/physiotherapist. Medications and meal replacements are prescribed including weight neutral diabetes medications and a very low energy diet will occur regardless and in the year prior to the trial , if appropriate . Some are being prepared for a new publically funded bariatric program over a year. Assessments will be at
• Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).

Recruitment will be facilitated by Senior clinicians at the clinic.
Measures are parts of standard care and include anthropometry (body height and weight (calibrated scales) and waist circumference), pulse and sitting blood pressure, metabolic parameters, and the following validated self-report online instruments:

• The Eating Disorder Examination-Questionnaire (EDE-QS) (Gideon et al., 2016) will assess eating disorder symptoms and behaviours such and binge eating. It has been validated against the gold standard full EDE-Q.
• Role Performance will be asked using the question applied in the Australian national survey (Andrews et al., 2001) i.e. the number of days in the past month the person has not been able to perform usual activities either in the home or at work),
• The Short-form 36 item version will be used to assess health related quality of life (HRQoL) in physical and mental health domains (Ware et al., 1992),
• The Kessler 10-item questionnaire will be used assess psychological distress (depression and anxiety) (Kessler et al., 1992).

A health care utilization survey designed to capture utilisation that may be related to the intervention and exclude irrelevant or random events such as infectious diseases and injuries will be administered. Health care utilisation will be translated into costs using average reimbursement rates.

An independent assessor will also administer additional tests of cognitive function (problem solving/decision making – as used in our prior research (Raman et al., 2018)) and a qualitative appraisal of participant experience to inform further program development. Specific tests will include the:
• Wisconsin Card Sorting Test – 64 item (WCST; Kongs, Thompson, Iverson, & Heaton, 2000) of set-switching.
• The Iowa Gambling Task of Decision Making (Brogan, Hevey, & Pignatti, 2010; Bechara, 2007).
• Serial 7 and Trail Making Task: Trail Making Test (TMT; Reitan & Wolfson, 1992) of sustained Attention & Speed of Information Processing.

Intervention: HAPIFED-M will be delivered over a 4-month (16 weeks) period in groups meeting for 12 sessions weekly then fortnightly. A Clinical Psychologist will administer HAPIFED-M sessions.
Each session will take 90 mins and address a psychoeducational topic and incorporate a cognitive remediation exercise to be practiced between sessions. These are designed to facilitate attention to detail and enhance and develop organization, planning and problem solving skills. Exercises include puzzles and tasks that facilitate attention to detail such as “Patterns” where people are asked to connect the dots and replicate a geometric figure and a task called “A Very Short Story,” where they read a short story and are asked to recount it in detail.

Specific topics:
1. Re-visiting nutrition education and appetite regulation: Hungry and non-hungry eating
2. Loss of control eating, binge eating, grazing and bulimia.
3. Our social connections: Getting social support and improving social connections.
4. Navigating emotions: Mindfulness and relaxation
5. New moves: Activity and exercise
6. Other ways of thinking. Unhelpful thinking styles & what to do about them.
7. Food, events and moods: Changes in eating related to events and moods
8. Body talk and embracing diversity: Addressing dissatisfaction with body shape and weight.
9. When things don’t go as planned: Problem solving
10. A more confident you: Positive self-evaluation
11. Planning when treatment ends: Where to now?
12. An end and a beginning

Group/peer support will be a key feature of the program as well as generic skills to build mental health and well-being. Specific skills will aid improved eating and nutrition such as training in problem solving, appetite regulation and hungry/non-hungry eating as well as reducing reliance on binge eating or other behaviours for mood regulation.

Type of study (prospective study or involving access to data or data linkage as relevant)
This is an open label uncontrolled trial testing the impact of a novel psycho-behavioural treatment, HAPIFED-M, on relapse prevention in people one-year after commencing multi-disciplinary weight loss program.

Population/Sample size
Participants are 60 adults, aged 18 years, who have achieved at least 5% weight loss after 12 months with the program. They will be recruited over a 1-year period after 12 month’s engagement with standard care (Time 0).

Expected duration of study and start times
The trial will start upon the grant of the Ethic’s approval. The trial endpoint for primary outcome is two years after presentation (Time -12) and the trial will thus run over 2 calendar years.
Attendance checklist and weight measurment will be performed at each session by the RA.
Intervention code [1] 314843 0
Behaviour
Intervention code [2] 315128 0
Treatment: Other
Intervention code [3] 315156 0
Lifestyle
Comparator / control treatment
Nill
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320527 0
Primary outcome is the maintenance of at least 5% weight loss assessed by digital scales
Timepoint [1] 320527 0

• Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).

Secondary outcome [1] 371927 0
Quality of life as assessed by SF-36
Timepoint [1] 371927 0
Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).
Secondary outcome [2] 373144 0
Psychological distress (depression and anxiety) as assessed by K10
Timepoint [2] 373144 0
Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).
Secondary outcome [3] 373145 0
Global eating disorder symptoms as measured by the EDEQuestionniare
Timepoint [3] 373145 0
Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).
Secondary outcome [4] 373245 0
Binge eating frequency as measured by the EDEQuestionnaire
Timepoint [4] 373245 0
Time -12 (at entry into the clinic 12 months prior to Time 0),
• Time 0 (baseline),
• Time 2 (mid therapy),
• Time 3 (end therapy), and
• Time 4 (6-month follow-up).

Eligibility
Key inclusion criteria
Participants are 60 adults, aged 18 years, who have achieved at least 5% weight loss after 12 months with the program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Statistical methods / analysis
Data will be cleaned and inspected for normality. Descriptive statistics will summarise features of participants and outcome measures. Data analysis will use multivariable logistic and multinomial logistic regression techniques with statistical adjustments for multiple comparisons. Mixed effects models will be used to investigate outcomes from baseline to T-4 (6-months follow-up). Mixed effects logistic regression will be used for dichotomous outcomes, such as achieving a 5% weight loss maintenance. All analyses will control for 1. Bariatric surgery history and 2. Weight-loss medication. The sample size of 60 will allow for up to up to 6 explanatory variables in multivariable analyses (Peduzzi et al., 1996). A cost-utility analysis will be done that estimates the long-term future costs and benefits of weight using a Markov model developed by THRI researcher Prof Girosi for the Australian population. Utility will be measured in Quality Adjusted Life-Years, derived from the SF-36 results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14082 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 26872 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 303126 0
University
Name [1] 303126 0
Western Sydney university
Country [1] 303126 0
Australia
Primary sponsor type
University
Name
Western Sydney university
Address
Western Sydney university
School of Medicine
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 303123 0
None
Name [1] 303123 0
Address [1] 303123 0
Country [1] 303123 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303674 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303674 0
Ethics committee country [1] 303674 0
Australia
Date submitted for ethics approval [1] 303674 0
01/07/2019
Approval date [1] 303674 0
Ethics approval number [1] 303674 0
South Western Sydney Local Health District

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

Contacts
Principal investigator
Name 94454 0
Prof Philipa Hay
Address 94454 0
Western Sydney University
School of Medicine
Locked Bag 1797
Penrith NSW 2751
Country 94454 0
Australia
Phone 94454 0
+61 2 4634 4575
Fax 94454 0
+61 2 4620 3891
Email 94454 0
p.hay@westernsydney.edu.au
Contact person for public queries
Name 94455 0
Philipa Hay
Address 94455 0
Western Sydney University
School of Medicine
Locked Bag 1797
Penrith NSW 2751
Country 94455 0
Australia
Phone 94455 0
+61 2 4634 4575
Fax 94455 0
+61 2 4620 3891
Email 94455 0
p.hay@westernsydney.edu.au
Contact person for scientific queries
Name 94456 0
Philipa Hay
Address 94456 0
Western Sydney University
School of Medicine
Locked Bag 1797
Penrith NSW 2751
Country 94456 0
Australia
Phone 94456 0
+61 2 4634 4575
Fax 94456 0
+61 2 4620 3891
Email 94456 0
p.hay@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.