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Trial registered on ANZCTR


Registration number
ACTRN12622000703707p
Ethics application status
Submitted, not yet approved
Date submitted
22/04/2022
Date registered
16/05/2022
Date last updated
16/05/2022
Date data sharing statement initially provided
16/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalisation of anti-obesity medication selection using the novel Auckland Eating Behaviour Questionnaire to identify Eating Behaviour Traits: examining the impact on weight loss
Scientific title
Personalisation of anti-obesity medication selection based on Eating Behaviour Traits: examining the effect of the novel Auckland Eating Behaviour Questionnaire on weight loss in patients with obesity and type 2 diabetes
Secondary ID [1] 306816 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
A-EBQ
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Obesity 325898 0
Type 2 diabetes 325899 0
Eating behavioural problems 325900 0
Condition category
Condition code
Diet and Nutrition 323208 323208 0 0
Obesity
Metabolic and Endocrine 323209 323209 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We propose that identifying predominant eating behaviour phenotypes, will improve pharmacotherapy selection to maximise weight loss and improvement in obesity related complications. We recently successfully validated in a large cohort (729 participants) the Auckland Eating Behaviour Questionnaire (A-EBQ), which identified three distinct clusters of eating behaviour traits that have been described in the literature. These are type C – constant cravers with reduced satiety and uncontrolled hunger leading to disinhibited eating and likely to respond best to phentermine, type E – emotional eaters, which comprises several forms of emotional eating, including food reward, eating when anxious, sad, or using food as a substitute and type F – feasters with weak post-ingestive satiation response resulting in overeating at mealtimes.'

'Eating behaviour congruent treatment group means that we will match the medication to the participants dominant eating behaviour trait, eating behaviour incongruent group means that participants will be treated with a medication that does not match their dominant eating behaviour. All participants will be equally randomised to either a congruent or incongruent treatment at the time of enrolment.

The groups will be as follows:
Eating behaviour congruent treatment group E: 25 participants with emotional eating assigned to Naltrexone/Bupropion 8/90mg 2 tablets twice daily

Eating behaviour congruent treatment group C: 25 participants with uncontrolled hunger assigned to Duromine 15mg tablets once daily

Eating behaviour congruent treatment group F: 25 participants with weak satiation response assigned to Liraglutide (1.8-3mg subcutaneous injection once daily)

Eating behaviour incongruent treatment group IE: 25 participants with emotional eating randomised to either Duromine 15mg tablets once daily or Liraglutide (1.8-3mg subcutaneous injection once daily)

Eating behaviour incongruent treatment group IC: 25 participants with uncontrolled hunger randomised to either Naltrexone/Bupropion 8/90mg 2 tablets twice daily

Eating behaviour incongruent group IF: 25 participants with weak satiation response randomised to either Naltrexone/Bupropion 8/90mg 2 tablets twice daily

Control group:
A ‘lifestyle only’ control group will have the lifestyle interventions described below to be able to compare the medication effect vs. the lifestyle and the effect of being enrolled in a clinical trial. This group will have a random selection of eating behaviour traits. There will be no placebo as the different treatments consist of different treatment modalities (two oral tablets twice daily, one oral capsule once daily, and a subcutaneous injections once daily) and randomisation is based on eating behaviour trait. The results of the eating behaviour assessment will be blinded to the investigator and the participants.

Mode of administration:
Duromine oral capsules will be administered by the participant once daily. Adherence will be measured by tablet return (pill count) at the time of re-prescription (3 monthly). There is no requirement for medication titration. The active intervention period on stable treatment dose is for the duration of six month. The medication will not be changed during this time, except the participant experiences problems or side effects.

Naltrexone/Bupropion 8/90mg oral tablets will be administered by the participant two tablets twice daily. Adherence will be measured by tablet return (pill count) at the time of re-prescription (3 monthly). The medication will be titrated to the target dose or the maximum tolerated dose with incremental steps of one additional tablet per week. The titration period will last up to one month. This time is part of the active intervention period of six month. Participants will be on stable treatment dose for the duration of the trial, except the participant experiences problems or side effects.

Liraglutide subcutaneous injections will be self-administered by the participant once daily. All participants will have a training session in self-injection techniques by the investigator before commencement of treatment. The medication will be titrated to the target dose of 3.0mg or the maximum tolerated dose in incremental steps of 0.6mg increase per week. This time is part of the active intervention period of six month. Participants will be on stable treatment dose for the duration of the trial, except the participant experiences problems or side effects. Adherence will be measured by injection pen inspection (pen return) at the time of re-prescription (3 monthly).

All participants will also receive a 'lifestyle' intervention. The registered dietitian will conduct two 60-90 min group meetings to provide basic nutrition guidelines on healthy food choices for improved glycaemic control as per the New Zealand Standards of Care for the Nutritional Management of Type 2 Diabetes in Adults Guidelines. The first session will be at the start of the trial (prior to starting the medication); the second session will be within four weeks after the first session. The first baseline group meeting will cover basic healthy eating and instructions for the ‘mealtime’ tool. The second group meeting, 4 weeks after the first session would provide diet counselling around basic healthy eating and cognitive behavioural therapy on implementing these healthy eating changes over the rest of the study period. There will be no other associated interventions and there will be no diet adherence monitoring during the trial, but a semi-structured interview will be conducted after three and six months, evaluating significant diet adherence concerns.

All participants will have free access to a diet and meal planning tool ‘mealtime’ (http://meatime.com). The instructions to the use of the meal planning ‘mealtime’ tool will be provided at the group meetings, encouraging participants to use the app at least once a week (allocate one hour planning time) to plan weekly meals a week in advance. The researchers will have the opportunity to access app analytics at the end of the trial. There will be no stipulation for change in the level of exercise during the trial.
Intervention code [1] 323280 0
Treatment: Drugs
Intervention code [2] 323457 0
Lifestyle
Comparator / control treatment
The ‘lifestyle only’ control group will have the lifestyle interventions described below only to be able to compare the medication effect vs. the lifestyle effect and the effect of being enrolled in a clinical trial. This group will have a random selection of eating behaviour traits.

There will be no placebo as the different treatments consist of different treatment modalities (two oral tablets twice daily, one oral capsules once daily, and subcutaneous injections once daily) and randomisation is based on eating behaviour trait. The results of the eating behaviour assessment will be blinded to the investigator and the participants.

All participants will also receive a 'lifestyle' intervention. The registered dietitian will conduct two 60-90 min group meetings to provide basic nutrition guidelines on healthy food choices for improved glycaemic control as per the New Zealand Standards of Care for the Nutritional Management of Type 2 Diabetes in Adults Guidelines. The first session will be at the start of the trial (prior to starting the medication); the second session will be within four weeks after the first session. The first baseline group meeting will cover basic healthy eating and instructions for the ‘mealtime’ tool. The second group meeting, 4 weeks after the first session would provide diet counselling around basic healthy eating and cognitive behavioural therapy on implementing these healthy eating changes over the rest of the study period. There will be no other associated interventions and there will be no diet adherence monitoring during the trial, but a semi-structured interview will be conducted after three and six months, evaluating significant diet adherence concerns.

All participants will have free access to a diet and meal planning tool ‘mealtime’ (http://meatime.com). The instructions to the use of the meal planning ‘mealtime’ tool will be provided at the group meetings, encouraging participants to use the app at least once a week (allocate one hour planning time) to plan weekly meals a week in advance. The researchers will have the opportunity to access app analytics at the end of the trial. There will be no stipulation for change in the level of exercise during the trial.
Control group
Active

Outcomes
Primary outcome [1] 330961 0
We will compare weight loss as a percentage of starting weight, measured using digital scales, between eating behaviour congruent treatment groups vs. eating behaviour non-congruent treatment vs. lifestyle only control group.
Timepoint [1] 330961 0
At six month after randomisation and treatment commencement.
Primary outcome [2] 331220 0
We will compare change in body mass index (BMI) as a percentage of starting BMI, measured in metric units (weight in kg, using digital scales, and height in cm, using wall mounted scales), between eating behaviour congruent treatment groups vs. eating behaviour non-congruent treatment vs. lifestyle only control group.
Timepoint [2] 331220 0
At six month after randomisation and treatment commencement.
Secondary outcome [1] 408270 0
Any change observed between treatment groups in HbA1c in mmol/mol measured using blood samples
Timepoint [1] 408270 0
At six month after randomisation and treatment commencement.
Secondary outcome [2] 409230 0
Any change observed between treatment groups in obesity-related metabolic markers assessed as a composite of blood pressure measured using a sphygmomanometer, lipid concentration measured using a blood test, renal and liver function measured using a blood test, urinary microalbuminuria measured using a morning spot urine sample.
Timepoint [2] 409230 0
At six month after randomisation and treatment commencement.

Eligibility
Key inclusion criteria
Participants, 18 - 75 years of age, male and female, who have obesity, WHO class 1 and above (BMI 30- 50 kg/m2) will be invited to take part. Participants will need to be willing and able to give informed consent for participation in the study and benefit from weight loss. Only those with one dominant eating behaviour (EB) domain score of >2 Standard deviations of the mean will be eligible to take part.
People in the lifestyle only group will have eating behaviours that match all possible eating behaviour traits. Patients with type 2 diabetes can be on oral hypoglycaemic medications, including metformin, sulphonylurea, pioglitazone, an SGLT2 inhibitor. Participants can have stable obesity-related complications.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous bariatric surgery, being diagnosed or currently suffering from a mental health problem, being prescribed psychotropic medication that could interfere or are a contraindication for the use of any one of the three weight loss medications. Other exclusion criteria include the presence of eating disorders (previously diagnosed or currently assessed) Patients with type 1 diabetes will be excluded, and treatment with a weight loss medication or a GLP1 agonist is an exclusion criterion. Patients cannot be on insulin. Exclusions are complications that would prevent the use of weight management medication, such as recent cardiovascular events, unstable angina, coronary artery bypass grafting, ischaemic stroke, myocardial infarction, percutaneous coronary intervention, epilepsy, or psychiatric disorder.

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 computerised assessment of the Auckland Eating Behaviour Questionnaire (A-EBQ) will be done by an independent observer (statistician), who will be responsible for assigning participants to the different intervention and control groups. The results will be blinded to the patients and the trial staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After assessment of eligibility, including in and exclusion criteria and informed consent, participants will repeat the A-EBQ and consistency of response will be evaluated. (note: participants from the validation cohort of the A-EBQ were asked about their willingness to participate in the clinical trial and more than 50% agreed to participate.)
Based on the A-EBQ predominant cluster type, patients will be randomised into their treatment groups. Randomisation will be done by an independent observer (statistician) based on a computer-generated algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features

Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations are based on available and comparative evidence (Acosta et al., Obesity | VOLUME 29 | NUMBER 4 | APRIL 2021). As in the comparative trial by Acosta et al., we intend to compare the composite primary and secondary outcomes of the three eating behaviour congruent groups (cohort 1 = sum of groups E+C+F) vs. the three eating behaviour incongruent treatment groups (cohort 2 = sum of groups EI+CI+FI) vs. the lifestyle only control group.
In to detect a 10% difference in reduction in BMI between the two cohorts using a one-sided test with 90% power, we require 33 participants in each, the eating behaviour congruent and the incongruent cohort. To detect a 7% difference in reduction in BMI between the two cohorts using a one-sided test with 90% power, we require 67 participants in each cohort.
Based on these calculations we intend to recruit 75 participants into each cohort, which means that we require 25 participants in each group. The lifestyle only control group will have 25 participants.
During the screening process we will identify potential participants who have one dominant Eating Behaviour trait only. Participants who have two co-dominant Eating Behaviour Traits will not be enrolled.
All continuous data will be presented as means and SEM. Categorical data will be presented as frequencies and percentages. We intend to use Pearson chi square and unpaired Student, two-tailed t-test for between-cohort comparisons for baseline and six month variables. All P-values <0.05 will be considered statistically significant. Standard multivariate regression analysis will be performed to account for other factors that may impact the outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
30/07/2023
Actual
Sample size
Target
175
Accrual to date
Final
Recruitment outside Australia
Country [1] 24699 0
New Zealand
State/province [1] 24699 0
Auckland

Funding & Sponsors
Funding source category [1] 311151 0
Charities/Societies/Foundations
Name [1] 311151 0
Auckland Medical Research Foundation
Country [1] 311151 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Dr Ole Schmiedel MD MRCP FRACP AFRACMA
c/o Auckland Diabetes Centre
Greenlane Clinical Centre
Building 4, Level 1
214 Greenlane West
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 312500 0
University
Name [1] 312500 0
University of Auckland
Address [1] 312500 0
Prof Rinki Murphy PhD, FRACP, MBChB
c/o Department of Medicine, Room 2016, Building 507, 28 Park Avenue, Auckland
Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019
Auckland 1142, New Zealand
Country [1] 312500 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310679 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 310679 0
Ethics committee country [1] 310679 0
New Zealand
Date submitted for ethics approval [1] 310679 0
06/05/2022
Approval date [1] 310679 0
Ethics approval number [1] 310679 0

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

Contacts
Principal investigator
Name 118490 0
Dr Ole Schmiedel MD MRCP FRACP AFRACMA
Address 118490 0
c/o Auckland Diabetes Centre
Greenlane Clinical Centre
Building 4, Level 1
214 Greenlane West
Auckland
1142
Country 118490 0
New Zealand
Phone 118490 0
+64 21831792
Fax 118490 0
Email 118490 0
oles@adhb.govt.nz
Contact person for public queries
Name 118491 0
Ole Schmiedel
Address 118491 0
c/o Auckland Diabetes Centre
Greenlane Clinical Centre
Building 4, Level 1
214 Greenlane West
Auckland
1142
Country 118491 0
New Zealand
Phone 118491 0
+64 21831792
Fax 118491 0
Email 118491 0
oles@adhb.govt.nz
Contact person for scientific queries
Name 118492 0
Ole Schmiedel MD MRCP FRACP AFRACMA
Address 118492 0
c/o Auckland Diabetes Centre
Greenlane Clinical Centre
Building 4, Level 1
214 Greenlane West
Auckland
1142
Country 118492 0
New Zealand
Phone 118492 0
+64 21831792
Fax 118492 0
Email 118492 0
oles@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a relatively small pilot study. Individual participant patient data may not be usable for any future meta-analysis. Our HDEC ethics application (to be submitted) and Maori consultation process (Maori Health Research Directorate) did not detail any data sharing arrangements, and the investigators understand that data sharing (including data dictionaries) may breach the requirements under the Maori Tikanga and our data management plan that complies with Chapter 12 of the NEAC Standards, which is required for this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15701Informed consent form  oles@adhb.govt.nz The Patient information document and consent form ... [More Details]
15844Ethical approval  oles@adhb.govt.nz Ethical approval is awaited, once obtained, it can... [More Details]



Results publications and other study-related documents

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Documents added automatically
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