Evaluation of a Novel Eating Disorder Prevention Program (Australian Diabetes Body Project) for Young Women with Type 1 Diabetes in a Clinic Setting: A Randomized Controlled Trial.

Not Applicable

Conditions: Diabetes Type 1
Eating disorders
Metabolic and Endocrine - Diabetes
Mental Health - Eating disorders

Registration Number: ACTRN12624000555550

Lead Sponsor: Mater Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1) Female
2) Age 15-25
3) Greater than 6 months post diagnosis of T1D
4) Administering insulin
5) Without ED-related hospitalisations in the prior 12 months
6) Answered yes” to the question do you have any body image concerns?”
7) Able to read and write English to a proficient level (that would impair their ability to complete online surveys).
8) Able to provide informed consent (those under 18 years of age must agree to participate, and also have a parent or guardian who will provide informed consent).

Exclusion Criteria

1) Established ED who are medically unstable (requiring hospital admissions in the preceding 12 months according to medical records and the young person’s self-report)
2) Rapid weight loss (>1kg/week over several weeks)
3) Body Mass Index (BMI) less than 14kg/m2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Dissatisfaction[Body Dissatisfaction Scale (BDS)<br>Ideal-Body Stereotype Scale - Revised (IBSS-R) Measured at baseline, post-intervention (six weeks), three months follow-up. The primary time-point for analysis will be three months. ];Eating disorder symptoms[Eating Disorder Examination Questionnaire (EDE-Q)<br>Diabetes Eating Problem Survey - Revised (DEPS-R) Measured at baseline, post-intervention (six weeks), three months follow-up. The primary time-point for analysis will be three months. ]

Secondary Outcome Measures

Name	Time	Method
Diabetes distress[Problem Areas In Diabetes (PAID) Scale<br>DAWN2 Impact of Diabetes Profile (DAWN-DIDP) Measured at baseline, post-intervention (six weeks), three months follow-up. ];Anxiety and depression symptoms will be measured as a composite secondary outcome.[Patient Health Questionnaire (PHQ-4) Measured at baseline, post-intervention (six weeks), three months follow-up. ];Health-related quality of life[World Health Organisation 5-item scale (WHO-5) Measured at baseline, post-intervention (six weeks), three months follow-up. ];Diabetes management[Medical data extraction of Glycated haemoglobin (HbA1c). Measured at baseline, post-intervention (six weeks), three months follow-up. ]