Impact of provision of abdominal aortic calcification results on fruit and vegetable intake: 12-week randomized phase 2 controlled trial

Abstract

Provision of non-invasive vascular imaging results to individuals has been shown to improve cardiovascular disease risk factor control: its impact on diet remains uncertain. In this two-arm, single-blind, parallel, 12-week randomized controlled trial, 240 participants, 57.5% females aged 60-80 y had abdominal aortic calcification and clinical assessments performed at a hospital clinic. Participants were randomized 1:1 to receive (intervention n = 121) or not (control n = 119) their calcification results. Both groups received educational resources on cardiovascular disease risk control and were unblinded to the intervention. Outcome measures were performed at baseline and 12 weeks. The primary outcomes of the study were changes in fruit and vegetable intake measures over 12 weeks assessed using plasma carotenoid concentrations (biomarkers of FV intake) and a food frequency questionnaire. Secondary outcomes included 12-week changes in other aspects of the diet, physical activity, body weight, blood pressure, heart rate, lipid profile, glucose concentrations, estimated cardiovascular disease risk score, and medication use. Between-group differences were tested using linear mixed-effects regression. There were no between-group differences in the primary outcomes at 12 weeks: plasma carotenoids (mean difference +0.03 µg/mL [95%CI -0.06, 0.13]) and fruit and vegetable intakes (+18 g/d [-37, 72]). However, the provision of calcification results led to between-group differences in serum total (-0.22 mmol/L [-0.41, -0.04]) and non-HDL (-0.19 mmol/L [-0.35, -0.03]) cholesterol, and estimated cardiovascular disease risk score (-0.24% [-0.47, -0.02]). No between-group differences were seen for other secondary outcomes. In this work, providing vascular imaging results did not improve diet but did improve some cardiovascular disease risk factors (Australian and New Zealand Clinical Trials Registry ACTRN12618001087246).

Fig. 1. The MODEL study flow chart.

IIT Intention to treat.

Fig. 2. Examples of the abdominal aortic calcification (AAC) imaging result letters provided to participants.

a No evidence of advanced blood vessel disease (AAC = 0); b Evidence of advanced blood vessel disease (AAC = 4); c Evidence of extensive advanced blood vessel disease (AAC = 17).