ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001079831

Ethics application status

Approved

Date submitted

6/07/2021

Date registered

16/08/2021

Date last updated

20/03/2023

Date data sharing statement initially provided

16/08/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

A telehealth program targeting addictive overeating for Australian adults with food addiction

Scientific title

Examining the efficacy of a telehealth intervention targeting addictive overeating in Australian adults: a randomised controlled trial.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

ACTRN12619001540101 is the pilot study of this study. This intervention will be used in a separate sample of participants to determine the effectiveness of the intervention on cardiometabolic and genetic risk markers, and neural reward responsiveness (see ACTRN12621001176853).

Health condition

Health condition(s) or problem(s) studied:

Food addiction

Addictive eating behaviours

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This project is a randomised controlled trial comprising three parallel arms. The primary outcome is the change in food addiction symptoms with random allocation to either 1) Active intervention arm, 2) Passive intervention arm, or 3) Control arm. Following eligibility screening, and online consent, randomisation will occur after the completion of baseline survey assessments. Survey measures will investigate symptoms of food addiction, dietary intake and eating related behaviours/habits, traits associated with personality and risk of addictive behaviour, mental health, quality of life and health care utilisation. Survey measures will also be completed at 3-month post-baseline assessment (primary time point), and the study also includes a 6-month post-baseline follow-up assessment.

Active Intervention:
The active intervention arm will target change in addictive eating behaviours using a multicomponent clinician led approach (telehealth sessions, program workbook and program website). Participants will receive five standardised one-on-one telehealth/phone sessions, with a Accredited Practising Dietitian, over a 3-month period (i.e. weeks 1, 2, 4, 8 and 12). Sessions will range from 15-45 mins. Telehealth sessions will be provided via the VSee platform (www.vsee.com). The active intervention uses, personalised feedback, skill-building exercises and goal setting to help individuals reduce their symptoms of addictive eating, improve their dietary intake and their relationship with food. The intervention is personalised based on an individual’s dominant trait/s associated with personality and risk of addictive behaviours (measured via The Substance Use Risk Profile Scale at baseline) and addresses a range of factors that influence one’s behaviour, both internal and external.

Each session will be facilitated by an Accredited Practising Dietitian with training in behaviour change. During Session 1, participants will be provided with feedback on their baseline scores of addictive eating and major trait/s associated with personality and risk of addictive behaviour. The participant’s main concerns with their food intake will be determined, and how their specific trait/s associated with personality and risk of addictive behaviour may relate to their food intake and addictive eating will be discussed. Participants will be introduced to various coping strategies, relevant to their major trait/s associated with personality and risk of addictive behaviour, that can be implemented to assist in improving their eating behaviours. This will include the ‘Distraction List’. During Session 2, participant’s will be provided with feedback on their dietary intake and diet quality; and participant’s will develop three nutrition goals using a ‘SMARTER Goal Checklist’. Participant’s progress with the coping strategies, introduced in session 1, will be reviewed and enablers/barriers to making changes to eating habits will be discussed. During Session 3, the 'Triggers for Overeating' task that was completed as home work will be discussed, and strategies created to overcome these triggers. Participant’s will be introduced to the ‘Mood Monitor’ worksheet to track emotional triggers for eating. During Session 4, the importance of sleep, physical activity and responsible intake of alcohol/ caffeine for emotional health will be discussed. This information, and information provided in sessions 1 to 3, will be consolidated into an overall plan for the participant to achieve their to achieve SMARTER goals.
Session 5 will consist of a brief check-in to assess progress and problem solve any concerns. Participants will be encouraged to continue with their goals and strategies.

Participants will have access to a study specific website and a participant workbook, both built for the study to support the materials discussed in the intervention sessions.
The website includes the following pages: 1) Home/Landing page: brief information about the program and login; 2) Dashboard: navigation page to access each of the program’s module pages; 3) Module pages: each of the five modules within the intervention has a separate page on the website. This includes the content for that module, complementary to that included within the corresponding telehealth session and section of the workbook; and 4) About us: brief information about the research/clinician team behind the program, including contact information (email).
The workbook consists of five modules: 1) Personality; 2) Food; 3) Skills; 4) Confidence; and 5) Moving forward. The clinician manual that will be used by the dietitian during each of the telehealth sessions has been converted into a workbook so that the content of the five modules mirrors that of the telehealth sessions. The workbook also contains activities/worksheets, discussed during the telehealth sessions, for the participants to complete. The amount of time spent completing activities in the workbook each week, between telehealth sessions, will take approximately 30 - 60 minutes. However, this may vary from person to person, and participants are advised to work through the workbook at a pace that is right for them.

On completion of the five telehealth sessions, participants will be invited to join a closed Facebook group from 3-months until the 6-month outcome survey measures are conducted. Joining the Facebook group is voluntary.

Dietitians administering the intervention will trained by the principal investigator prior to study implementation. A detailed clinician manual will be used by the dietitian for all sessions to ensure treatment fidelity. Dietitians will also be required to follow each session as outlined in the manual. Standardised records of implementation of each session will be kept by the dietitian. Regular supervisory meetings will be conducted with the dietitians and led by the principal investigator. Participant adherence to the intervention will be assessed by a session attendance checklist completed by a member of the research team. Dietitians administering the telehealth sessions will monitor completion of homework tasks and workbook activities at the start of telehealth sessions 2 to 5. Assistance will be provided by the dietitian at this time if participants experienced any difficulties completing the homework tasks/activities. Additionally, to assist with adherence, on completion of each telehealth session the dietitian will email a personalised ‘Addictive Eating Action Plan’, completed on a standardised template, to the participant.

Passive intervention arm:
Participants will receive the intervention via self-guided approach, with access to the five-module workbook and website (as described above), but without the telehealth consults. The content of the workbook modules mirrors the content of the five telehealth sessions. Participants will be asked, on receipt of the workbook, to complete the workbook within a 3-month period. Following the 3-month self-guided learning period, participants will be invited to join a closed Facebook group from 3-months until the 6-month outcome survey measures are conducted. Joining the Facebook group is voluntary. The proportion of the workbook completed by participants in the passive intervention arm will not be monitored. As a measure of adherence, engagement with the website and the Facebook group will be monitored. For example, the number of website visits, length of website visits, website visitor path, and website top pages; number of Facebook likes and comments, and number of Facebook visits will be measured.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

Control arm:
Participants will receive personalised dietary feedback on baseline surveys, provided by an automated report, generated from the Australian Eating Survey. This is consistent with standard dietary care if the participant was to see a dietitian.
The comparator groups were chosen to provide a passive delivery option of the intervention which would be consistent with a self-guided Cognitive Behaviour Therapy approach, and a control group consistent with a standard version of dietetic care. Participants in the control group will be offered access to the participant workbook and study website after the completion of the 6-month assessment.

Control group

Active

Outcomes

Primary outcome [1]

Food addiction symptoms and severity assessed via the Yale Food Addiction Scale (YFAS 2.0)

Timepoint [1]

Baseline (pre-intervention), 3-months (primary timepoint) and 6-months after intervention commencement

Secondary outcome [1]

Changes in dietary intake and quality will be assessed using the Australian Eating Survey (AES). The will include: (1) % Daily energy intake from core foods and non-core foods; (2) average daily energy intake, % Daily energy intake contributed by macronutrients, micronutrient intakes; and (3) overall diet quality (Australian Recommended Food Score provided by the AES).

Timepoint [1]