A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial

Abstract

Background The Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored. Objective This study aims to assess the effectiveness of a remotely provided Mediterranean diet–based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF). Methods The PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: Recommended foods, Menus, News and Online resources, Practical tips, Mediterranean diet classroom, and Your personal experience. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone. Results A total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; P<.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (P<.001), olive oil (P<.001), whole grain cereals (P=.002), pulses (P<.001), nuts (P<.001), white fish (P<.001), fatty fish (P<.001), and white meat (P=.007), and a significant reduction in refined cereals (P<.001), red and processed meat (P<.001), and sweets (P<.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (P<.001) and fiber (P<.001), and they decreased their intake of carbohydrates (P=.02) and saturated fatty acids (P<.001) compared with the control group. Conclusions The remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation. Trial Registration ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843

Effectiveness of dietary interventions delivered by digital health to adults with chronic conditions: Systematic review and meta‐analysis

“…Five pooled studies (n = 927 participants) 28,33,34,41,54 found no significant effect of digital health intervention on protein intake (MD = −0.13 grams/day; 95% CI = −1.42 to 1.16; p = 0.84; I 2 = 12%). There were three studies 34,35,44 that reported varying measures of protein intake (e.g., protein component of diet quality index score and adherence to protein intake).…”

“…The characteristics and main findings of the studies are provided in Table 1. Studies were conducted within hospitals (n = 20 studies), [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] community health care (n = 16 studies) [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60] or a combination of these settings (n = 3). [61][62][63] The majority of studies were randomised control trials (n = 37 studies) with either two (n = 31 studies), [25][26][27][28][29][30][31][33][34]…”

“…The two non-randomised control trials each had two study arms. 49,60 Study populations included adults with cardiovascular disease (CVD) (n = 16 studies), 25,27,[29][30][31]33,35,37,39,40,43,48,50,53,60,62 Type 2 DM (n = 13 studies), 26,32,41,42,44,45,52,55,58,59,61,63 unspecified DM (n = 1 study), 38 obesity (n = 4 studies), 46,49,56,57 CKD (n = 3 studies) 28,51,54 and combined population group (n = 2). 34,47 The duration of the studies ranged from eight weeks to 24 months.…”

“…A range of digital health tools was used in these interventions, internet (n = 17 studies), [29][30][31][32][34][35][36][37]40,47,48,50,51,[57][58][59]63 including apps and/or messaging systems (n = 16 studies), [25][26][27][28][41][42][43][44]46,49,[52][53][54]56,60,62 electronic software (n = 1 study) 45 or combination of these methods (n = 5 studies). 33,38,39,55,61 The control groups were provided usual care that did include nutrition or lifestyle counselling, printed educational resources, online articles or e-mailed newsletter (but with no tailored dietary information). Most of the studies (n = 33 studies) [25][26][27][29][30][31][32][34]…”

“…Meta-analysis of seven studies (n = 993 participants) 28,33,34,46,48,54,62 found digital health interventions did result in a significant reduction in sodium intake (SMD = −0.22; 95% CI = −0.44 to −0.01; p = 0.04; I 2 = 59%). Three studies 43,51,53 reported varying measures of sodium intake (e.g., urine salinity or adherence of salt intake) and could not be included in the meta-analysis; two of the three studies reported significant differences favouring digital health interventions over the control group (see Supporting information, Table S2).…”