An investigation in Australian adults, with and without food addiction, to determine if a behavioural intervention for addictive eating influences cardio-metabolic profiles and neural reward responses.

Not Applicable

Recruiting

• Conditions: Food addiction; Addictive eating behaviours; Diet and Nutrition - Obesity; Mental Health - Addiction

• Registration Number: ACTRN12621001176853
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Key inclusion criteria: Individuals with and without food addiction (assessed by the Yale Food Addiction Scale) living in the Newcastle area, NSW (Australia) who are proficient in English, with access to the internet, and able to visit the Hunter Medical Research Institute (Kookaburra Circuit, New Lambton Heights, NSW) for two assessment sessions 3-months apart. Additional inclusion criteria include BMI equal to or greater than 20 kg/m2, body mass less than 150kg (due to the table weight limit of the fMRI scanner), being right-handed, having normal or corrected-to-normal vision (i.e. wearing glasses), having no metallic or electronic implants, able to lie supine in the fMRI scanner for 1 hour and to perform computer-based tasks.

Exclusion Criteria

Individuals with a BMI less than 18.5 kg/m2, or those with purging behaviours (as identified by the Eating Disorder Examination Questionnaire, EDEQ, in the eligibility screen) or those with severe psychiatric illness (e.g. schizophrenia or bipolar disorder) or self-reported neurological or psychological illness/health condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test (feasibility) if the intervention for addictive overeating results in any neural brain changes assessed by structural image and resting-state fMRI<br><br>[Baseline and 3-months post commencement of intervention ];To test (feasibility) if the intervention for addictive overeating results in any changes in neural brain responses to core vs. non-core foods assessed by a food specific Go/No go task-based fMRI[Baseline and 3-months post commencement of intervention];To test (feasibility) if the intervention for addictive overeating results in changes in cardiometabolic profiles (plasma concentrations of HbA1c, glucose, total cholesterol, LDL, HDL, triglycerides, ghrelin, leptin, oxytocin, cortisol, cholecystokinin) assessed by commercial laboratory and enzyme-linked immunoassay (ELISA)[Baseline and 3-months post commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Genetic profiles with DNA in fasting blood samples assessed by ELISA [Baseline and 3-months post commencement of intervention ];Executive function assessed by Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)[Baseline and 3-months post commencement of intervention ];Two motivational systems: the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS) will be assessed by BIS/BAS Scale.[Baseline and 3-months post commencement of intervention ];Impulsivity assessed by SHORT UPPS Impulsive Behavior Scale (UPPS-P)[Baseline and 3-months post commencement of intervention ];Hedonic hunger assessed by Power of Food Scale (PFS)[Baseline and 3-months post commencement of intervention ]