Can a primary health care intervention prevent diabetes in people with depression?

Active, not recruiting

• Conditions: Incident Type 2 Diabetes; Depression; Metabolic and Endocrine - Diabetes; Mental Health - Depression

• Registration Number: ACTRN12616000397415
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

We will include participants meeting all of the following criteria:
1. Give freely written informed consent
2. Aged 40 to 74 years; the arbitrary lower age limit was chosen because of the sharp rise in the prevalence and incidence of diabetes in middle-aged Australians. The arbitrary upper age limit of 74 years was chosen because of the sharp rise in deaths in Australians aged 75 years or older
3. At least overweight defined by body mass index greater than or equal to 25 kg/m2 computed from measured height and weight
4. Confirmed pre-diabetes defined by impaired fasting glucose (IFG) (FPG levels plasma glucose levels 5.6–6.9mmol/L), or impaired glucose tolerance (IGT) (2-h PG Oral Glucose Tolerance Test [OGTT] levels of 7.8–11.0mmol/L), or HbA1c levels 5.7–6.4% according to the American Diabetes Association (ADA) criteria; pre-diabetes patients treated with Metformin are eligible
5. Clinically significant depression (using scores greater than or equal to 10 for moderate to severe symptoms) with the Patient Health Questionnaire-9 (PHQ-9)
6. Be at either (1) pre-contemplation, (2) contemplation, or (3) preparation stage of readiness to lose weight using the following question and response options based on the Prochaska Stage of Behavior Change model

Exclusion Criteria

1.Diabetes (type 1 or monogenic or type 2 or gestational diabetes) determined by self-report (doctor diagnosis or prescriptions for anti-diabetes medications)
2.Current or previous psychotic symptoms by standard medical history/self-report
3.Currently receiving treatment for breast, liver cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Non-melanoma skin cancer(s) treated with curative intent are eligible
4.Unable to communicate effectively in English judged by the Investigator during face-to-face or telephone contact to screen for study eligibility
5.Current or planned pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified