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Table 1 Schedule of measurements

From: A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

Variable

Instrument

Time point

Self-report

  

Diet quality

Diet screening tool [18]

Screening, 6-months#

Psychiatric conditions

SCID-I/NP*

Screening

Personality disorders

Standardised Assessment of Personality – Abbreviated Scale (SAPAS) [19]

Screening

Depression

MADRS* [17]

Screening, baseline, 3-, 6-months#

Anxiety

Hospital anxiety depression scale [26]

Baseline, 3-, 6-months

Depression severity

Clinical global impressions scale [27]

3-months

Mood

Profiles of Moods State (POMS) [28]

Baseline, 3-months

Quality of life, utility, wellbeing

Assessment of Quality of Life (AQoL-8D) [25]; WHO wellbeing scale [29]

Baseline, 3-months

Diet intake

Food Frequency Questionnaire (FFQ) [23]

Baseline, 3-months

Physical activity

International Physical Activity Questionnaire (IPAQ) [24]

Baseline, 3-months

Smoking

Self-report

Baseline, 3-months

Medications

Self-report

Baseline, 3-months

Medical conditions (including family history)

Self-report (Doctor diagnosed) depression, anxiety, myocardial infarction, angina, hypercholesterolemia, high blood pressure, diabetes

Baseline, 3-months

Health care resource utilisation

Self-reported hospitalisations, attendances at physicians, psychologists, allied health, complementary and alternative medicine providers

Baseline, 3-months

Self efficacy

General Self Efficacy Scale (GSE) [30]

Baseline, 3-months

Participant satisfaction

Diet preference score

3-months

Lost productivity

Self-reported time lost from paid and unpaid work

Baseline, 3 months

Anthropometric & clinical

  

Waist, weight, height, blood pressure

Height to nearest 0.1 cm. Body weight to nearest 0.1 kg. BMI = weight divided by height squared kg/m2, Digital metre

Baseline, 3-months

Biochemical

  

Erythrocyte fatty acids and cartenoids

Venous blood sample (fasting)

Baseline, 3-months

High-density lipoprotein, Lower-density lipoprotein, total cholesterol

As above

Baseline, 3-months

Triglycerides, blood glucose

As above

Baseline, 3-months

  1. * clinician administered; #6-month assessment via telephone. Baseline= pre-intervention, 3-months= post-intervention, 6-months= 3-months post-intervention.