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Trial registered on ANZCTR


Registration number
ACTRN12615000628549
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
17/06/2015
Date last updated
26/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuromodulation as a treatment for food addiction in obese individuals
Scientific title
Effect of transcranial random noise stimulation (tRNS) on food craving in obese individuals with food addiction
Secondary ID [1] 286821 0
Nil known
Universal Trial Number (UTN)
U1111-1168-7122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food addiction 295194 0
Obesity 295195 0
Condition category
Condition code
Diet and Nutrition 295444 295444 0 0
Obesity
Mental Health 295545 295545 0 0
Addiction
Mental Health 295546 295546 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: placebo tRNS
Group 2: active tRNS

For tRNS:
a) Dose administered: 1 mA for 10 minutes with 60 seconds ramp up and ramp down at the beginning and end of each stimulation session.
b) Frequency of stimulation: 3 times a week for 2 weeks.
c) Treatment will be administered by a trained Assistant Research Fellow
d) Mode of administration: external head device (Starstim system- NE neuroelectrics) worn with electrodes on anterior cingulate cortex (4 cathodes at F7, T3, F8 and T4; 1 anode at Fz)
e) Monitoring adherence using Case Report Forms
Intervention code [1] 291979 0
Treatment: Devices
Comparator / control treatment
For placebo tRNS, current will be applied at 1mA for 60 seconds ramp up and 3 seconds ramp down before terminating. tRNS device will be worn at the same frequency and duration as intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 295177 0
Food craving will be assessed using the Oxford Leeds Questionnaire ( a validated computer task to measure food craving). Participants will be shown different paired presentation of food items (96 trials) and will be asked to select their most wanted food as quickly and as accurately as possible. Participants will not be aware of the measurement of their reaction time for the choices they make allowing a covert assessment for implicit motivational wanting of a particular food.
Timepoint [1] 295177 0
Baseline, after tRNS, week 4, and week 6 after randomisation
Secondary outcome [1] 314949 0
Day to day craving. Information on the food being craved for will be self-reported on a daily basis in a questionnaire designed specifically for this study.
Timepoint [1] 314949 0
baseline, week 6 after randomisation
Secondary outcome [2] 315234 0
Liking of food. The validated Leeds-Oxford questionnaire will be used to assess food liking. Participants will be shown a single food item and will be asked to rate "how pleasant would you find the taste of this food right now?" on a visual analogue scale (100-unit).
Timepoint [2] 315234 0
Baseline, after tRNS and week 6 after randomisation
Secondary outcome [3] 315235 0
Satiety. Electroencephalogram (EEG) using a 19 electrode cap on a Mitsar -201 system will be conducted. Participants will be asked to consume a liquid meal (Sanitarium Up and GO) until they reach satiety.
Fasting EEG will be recorded and a second EEG will be conducted to assess 'peak satiety'. The participant will be allowed to leave the clinic thereafter and asked to return at 360 minutes for another follow-up EEG.
During this process, participants will also be asked to complete a numerical rate scale to assess hunger and satiety at fasting state, at peak satiety, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes.
Timepoint [3] 315235 0
Baseline, after tRNS, 6 weeks after randomisation
Secondary outcome [4] 315236 0
Genetic markers. Blood sample will be collected to assess for TaqA1 alleles of dopamine D2 receptor and the opioid receptor OPRM1 gene.
Timepoint [4] 315236 0
Baseline
Secondary outcome [5] 315237 0
Psychological and behavioural outcomes.

Participants will be given the following questionnaires.
a) Addictive Tendency Questionnaire - A 96-item questionnaire measuring addictive tendencies across 12 domains.
b) Intuitive Eating Scale (IES) - A 21-item questionnaire assessing eating in response to hunger and satiety cues rather than situational and emotional cues.
c) Dutch Eating Behaviour Questionnaire (DEBQ) - A 51-item questionnaire assessing restrained, emotional and external eating.
d) Mindful Eating Scale - A 28-item questionnaire measuring mindful eating (i.e., being aware of and appreciating the effects of food on the senses).
e) Binge Eating Scale - A 16-item questionnaire assessing the presence of binge eating which may be indicative of an eating disorder.
f) Behavioural Inhibition System (BIS) – Behavioural Activation System (BAS) questionnaire - A 20-item scale measuring the two motivational systems (inhibition and activation) underlying behaviour and affect.
g) Hypomanic Personality Scale - A 48-item questionnaire assessing stable hypomanic traits.
h) State/Trait Food Cravings Questionnaires - A 36-item questionnaire assessing temporal and situational states of food craving.
i) Beck Depression Inventory-II (BDI-II) – A 21-item self-reported inventory for measuring severity of depression.*
j) Beck Anxiety Inventory (BAI) – A 21-item self-reported inventory for measuring severity of anxiety.*

* Participants will be asked to complete the BDI-II and BAI after their physical and vital signs evaluation to screen for depression and anxiety.

Timepoint [5] 315237 0
Aside from the BDI-II and BAI used to screen for depression and anxiety, the rest of the questionnaire will be completed at baseline and 8 weeks after randomisation.

Eligibility
Key inclusion criteria
aged 20-60, BMI more or equals 30, Scores equals to or more than 3 on the Yale Food Addiction Scale
Minimum age
20 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Major weight gain or loss in the last 6 months (5 kg or more),
recent significant head injuries, psychiatric disorders, history of epilepsy, metal implants, recurring headache, previous bariatric surgery, previous diagnosis of eating disorder, females who are or intend to become pregnant, other health problems (diabetes, cancer, heart disease, uncontrolled hypertension)

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)
Recruitment via advertisements. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to provide 80% power to detect a difference of 0.07 in mean food craving (SD 0.06) using two-sided tests at the 0.05 level, without making any assumptions about the correlation between baseline and follow-up values, 14 participants are needed in each group (treatment tRNS vs placebo tRNS).

Twenty participants (10 in each group) will be recruited followed by an interim analyses of the data. Depending on the results from the interim analyses (treatment versus placebo), the trial may be terminated earlier.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 6907 0
New Zealand
State/province [1] 6907 0
Dunedin/Otago

Funding & Sponsors
Funding source category [1] 291367 0
University
Name [1] 291367 0
University of Otago
Country [1] 291367 0
New Zealand
Primary sponsor type
University
Name
Department of Medicine, University of Otago
Address
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street
Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 290045 0
University
Name [1] 290045 0
Department of Surgical Sciences, University of Otago
Address [1] 290045 0
Department of Surgical Sciences
6th Floor Dunedin Hospital
201 Great King Street
Dunedin, 9016
Country [1] 290045 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292925 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292925 0
Ethics committee country [1] 292925 0
New Zealand
Date submitted for ethics approval [1] 292925 0
Approval date [1] 292925 0
18/05/2015
Ethics approval number [1] 292925 0
15/STH/68

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 471 471 0 0
/AnzctrAttachments/368646-HDEC_Letter_-_15STH68_-_Approved_Application.pdf

Contacts
Principal investigator
Name 57642 0
A/Prof Patrick Manning
Address 57642 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street
Dunedin 9016
Country 57642 0
New Zealand
Phone 57642 0
+64 03 474 0999
Fax 57642 0
+64 03 474 7725
Email 57642 0
Patrick.Manning@southerndhb.govt.nz
Contact person for public queries
Name 57643 0
Patrick Manning
Address 57643 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street
Dunedin 9016
Country 57643 0
New Zealand
Phone 57643 0
+64 03 474 0999
Fax 57643 0
+64 03 474 7725
Email 57643 0
Patrick.Manning@southerndhb.govt.nz
Contact person for scientific queries
Name 57644 0
Patrick Manning
Address 57644 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street
Dunedin 9016
Country 57644 0
New Zealand
Phone 57644 0
+64 03 474 0999
Fax 57644 0
+64 03 474 7725
Email 57644 0
Patrick.Manning@southerndhb.govt.nz

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.