Skip to main content
. 2023 Mar 30;12:e44867. doi: 10.2196/44867

Table 2.

Standard Protocol Items: Recommendations for Interventional Trials schedule of enrollment, interventions, and assessments.


Time point

Baseline (Maroondah BreastScreen) Follow-up (telephone) Follow-up (telephone)

Day 1 4 weeks 12 weeks
Enrollment

Verbal information and provision of trial information sheet ✓


Informed consent (written or verbal; time-dependent) ✓


Eligibility and demographic information ✓




Randomization ✓

Intervention

Active condition: Health4Her alcohol brief intervention + lifestyle information ✓


Control condition: lifestyle information ✓

Assessmenta

Knowledge assessment of breast cancer risk factors, including alcohol ✓ ✓ b

14-day timeline follow-back [45] ✓ ✓ ✓

Australian Institute of Health and Welfare alcohol frequency and quantity items [46,47] ✓ ✓ ✓

Assessment of alcohol literacy ✓ ✓

European Health Interview Survey-Quality of Life (single item) [50] ✓ ✓ ✓

Short Form Health Survey [49] ✓ ✓ ✓

Assessment of physical activity [51] and fruit and vegetable consumption [52] ✓ ✓ ✓

aAlcohol assessments were nested among general health and lifestyle questions to conceal alcohol focus.

bPrimary outcome.