Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001163493p
Ethics application status
Submitted, not yet approved
Date submitted
14/08/2016
Date registered
26/08/2016
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
GP based obesity program; Dr Mark McGrath/ University of Queensland
“The Non-Diet Approach To Healthy Eating Program”
Scientific title
A prospective cohort study (+/- control) on the effectiveness of psychological intervention + diet & exercise advice on overweight & obese adults in a general practice setting utilising allied health professionals.
Secondary ID [1] 289930 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 299903 0
Condition category
Condition code
Diet and Nutrition 299805 299805 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Structured general practice consultations - beginning with 6 prolonged visits (ie >40mins) to introduce the basic concepts of the intervention, invite participants to practice a skill at home then return to troubleshoot and learn the next skill/ concept. Patients who are interested will begin with a 1-2 hour group session which acts as an introduction and to see whether they are interested in progressing on. The sessions are one on one thereafter. There is an initial medical examination, consent and paperwork session then 6 one on one visits with GP occurring fortnightly.

Obesity Program Summary
0.Medical Assessment, Consent, Shifting Focus From Weight
*Screen for causes & comorbidities
*Arrange Ix including DEXA scan
*Consent
*Discuss visceral fat & waist circumference
*Introduce values
1. The Basics - Values & Mindfulness
*Introduce Values, explain why important; Generate values statement
*Introduction to ACT & Mindfulness; practice
(Notice; these don’t specifically relate to eating/ food at this time)
2. Mindful eating
*Analyse values statement
*Mindfulness applied to eating when hungry & Mindful eating
*“Choice point model”
3. Over-eating, hunger, cravings
*Eating until satisfied not full
*Hunger scale
*Cravings
*Tie in with values & choice point model
4. REVISION & FOOD QUALITY, DIETICIAN REFERRAL
*Revise 4 main points;
a.Eat when you’re hungry
b.Eat mindfully
c.Eat until satisfied not full (hunger scale)
d.Cravings
*Priming/ body self-regulates
*unprocessed food
*+/-drinks
*+/- treats
5. EXERCISE “Movement”, REFER EXERCISE PHYSIOLOGIST
*Benefits of exercise (least of all weight loss)
*A more or less approach
6. Values, deeper issues, psychology, REFER PSYCHOLOGIST
*Not living in alignment with values/ ‘Subconscious’ factors/ psychologist referral
*not eating to manage uncomfortable feelings


Thereafter sessions will be approximately monthly. They will involve troubleshooting, assessing progress, introducing new concepts as relevant to the patient as an individual. The GP will suggest the interval but it is at the discretion of the patient. The sessions may become more spaced out as time progresses according to need. I anticipate 2-3 years of ongoing sessions but there is not maximum per se. There will be significant individual variation. It is hoped that these sessions will foster adherence until the patient is self-sufficient. If patients do drop out they are likely to remain patients of the practice so follow-up will still be possible and it will be easy to commence where they left off should they choose to do so in the future.

The intervention is based mainly on the psychological principles of ACT (acceptance and commitment therapy).
All patients will be referred to a Psychologist, Dietitian & Exercise physiologist who all practice in a similar manner based around ACT so that patients will receive a consistent message,
As per any usual referral from the GP to an allied health professional, the GP does not dictate the content of the sessions. They will be tailored to suit the individual at the discretion of the allied health professional. The point of difference is that each allied health professional will be familiar with and incorporate ACT techniques into their practice and be familiar with the philosophy of the program. I anticipate that most patients will spend a higher proportion of their visits with the psychologist, then the dietician and the least with the exercise physiologist. The interval between visits will be determined by both the patient and allied health professional. This is likely to impact the interval of visits back to the GP. For example if in a two-month the patients has numerous visits each of the three allied health professionals they are not likely to require frequent troubleshooting with their GP.

Phone calls/ letters or email may also be used to improve adherence. All patients will be encouraged to read one of three self-help books to also improve adherence and skills.

Self Help books;
*Neuroslimming – Dr Helena Popovic
*The Diet Trap – Jason Lillis, Joanne Dahl, Sandra Weineland (audiobook & hard copy)
*The Weight Escape – Joseph Ciarocchi, Ann Bailey & Russ Harris Headspace – Mindful eating
Intervention code [1] 295611 0
Behaviour
Intervention code [2] 295620 0
Treatment: Other
Comparator / control treatment
Participants will be prospectively enrolled. I hope to also prospectively recruit use a control group if possible consisting of a group of overweight, obese or morbidly obese patients from the GP practice next door. Data collected will include annual height, weight, waist circumference, QOL scale and whether they participated in 'standard' treatment for obesity with their GP, no treatment or commercial treatment. Any treatment received by the control group will be at the discretion of their usual GP (ie the GP clinic next door).
Control group
Active

Outcomes
Primary outcome [1] 299276 0
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
Weight will be measured by the doctor.
Timepoint [1] 299276 0
annual for 3 years
Primary outcome [2] 299277 0
Waist circumference - as measured by GP or practice nurse using a tape measure
Timepoint [2] 299277 0
annual for 3 years
Primary outcome [3] 299278 0
DEXA body fat scan
Timepoint [3] 299278 0
annual for 3 years
Secondary outcome [1] 326707 0
Blood Pressure - as measured by GP or practice nurse using a sphygmomanometer
Timepoint [1] 326707 0
annual for 3 years
Secondary outcome [2] 326708 0
Fasting lipids - as measured by blood tests collected by the local pathology provider
Timepoint [2] 326708 0
annual for 3 years
Secondary outcome [3] 326768 0
Fasting blood sugar & HBA1c (composite outcome measure; both are a reflection of impaired fasting glucose or insulin resistance) - as measured by blood tests collected by the local pathology provider
Timepoint [3] 326768 0
annual for 3 years
Secondary outcome [4] 326769 0
Liver function tests - as measured by blood tests collected by the local pathology provider
Timepoint [4] 326769 0
annual for 3 years

Eligibility
Key inclusion criteria
Overweight, obese or morbidly obese adults
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Frank eating disorder

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294303 0
Self funded/Unfunded
Name [1] 294303 0
N/A
Country [1] 294303 0
Primary sponsor type
University
Name
University of Queensland
Address
UQ Discipline of General Practice
The Universty of Queensland, St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 293143 0
None
Name [1] 293143 0
Address [1] 293143 0
Country [1] 293143 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295730 0
University of Queensland
Ethics committee address [1] 295730 0
UQR&I Human Ethics Coordinators
The University of Queensland, St Lucia, Qld 4072
Ethics committee country [1] 295730 0
Australia
Date submitted for ethics approval [1] 295730 0
15/08/2016
Approval date [1] 295730 0
Ethics approval number [1] 295730 0

Summary
Brief summary
HYPOTHESIS – That a psychology based obesity intervention in a GP setting will result in sustainable improvements in both QOL (quality of life) of overweight, obese & morbidly obese patients and result in improvements in measurable outcome parameters such as reduced visceral fat, improved blood sugar, lipids and fatty liver.
Trial website
Trial related presentations / publications
Public notes
POTENTIAL RISKS

The radiation dose from DEXA scan is negligible. The patient will receive approximately the same amount of radiation that the public receives from background radiation in a single day. The operator sits right next to the patient in the room during the scan, which is completely safe to do because the radiation dose is so low. It has been approximated at 0.002 mSv (a seven hour aeroplane flight is approximated at 0.05 mSv ie 25 times the dose of a single scan).

All patients will be screened for eating disorders at the time of initial assessment using the Fairburn Eating Disorder Questionnaire EDE-Q6. If an eating disorder is suspected they will be referred on appropriately. Given the program isn’t aimed at weight loss and doesn’t encourage restrictive eating, any undetected eating disorders are unlikely to come to harm, other than a delay in more targeted therapy until they see a psychologist.

Should other medical or psychological issues arise these will be addressed and managed appropriately.

Patients will be screened medically at the initial consult. If they are considered at high-risk from a cardiac perspective of commencing exercise they will be offered appropriate investigations such as a Stress ECHO. Utilising an exercise physiologist will help to minimise injuries with recommencement of exercise.

Attending a psychologist skilled in ACT & obesity/ eating disorders will help mitigate many psychological risks. Some foreseeable examples include coming to realise that they feel unsafe without their excessive weight as they may have been using it as a self-protective measure to make them less attractive to others sometimes as a result of trauma such as childhood abuse. Weight loss can also trigger feelings of uncertainty for significant others resulting in relationship issues.

CONSENT
Patients will be made aware that they are anonymously contributing to medical research including publication.

Participants are free to leave at any time but will be asked to keep in contact for a minimum of two years for research purposes to document the reasons they chose to drop-out and ideally their progress after they leave. If they are long-term patients of the practice this should not pose a great problem and it is hoped that follow-up will be able to be achieved to three years or longer.

Informed financial consent will also be obtained. Costs will be in line with out-of-pocket costs patients would usually expect to pay for medical referrals & services. This project in unfunded and is intended to run self-sufficiently in a predominantly private-billing GP setting.

Contacts
Principal investigator
Name 68242 0
Dr Mark McGrath
Address 68242 0
Kenmore Family Medical Centre
1/2081 Moggill Rd
Kenmore Qld 4069
Country 68242 0
Australia
Phone 68242 0
+61 733782988
Fax 68242 0
Email 68242 0
[email protected]
Contact person for public queries
Name 68243 0
Dr Mark McGrath
Address 68243 0
Kenmore Family Medical Centre
1/2081 Moggill Rd
Kenmore Qld 4069
Country 68243 0
Australia
Phone 68243 0
+61 733782988
Fax 68243 0
Email 68243 0
[email protected]
Contact person for scientific queries
Name 68244 0
Dr Mark McGrath
Address 68244 0
Kenmore Family Medical Centre
1/2081 Moggill Rd
Kenmore Qld 4069
Country 68244 0
Australia
Phone 68244 0
+61 733782988
Fax 68244 0
Email 68244 0
[email protected]

No information has been provided regarding IPD availability


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.