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

10.2196/21436 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e21436
Author(s):  
Leticia Goni ◽  
Víctor de la O ◽  
M Teresa Barrio-López ◽  
Pablo Ramos ◽  
Luis Tercedor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Mediterranean Diet ◽  
Retention Rate ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mediterranean

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

scholarly journals A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Leticia Goni ◽  
Víctor de la O ◽  
M Teresa Barrio-López ◽  
Pablo Ramos ◽  
Luis Tercedor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Mediterranean Diet ◽  
Retention Rate ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mediterranean

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: <i>Recommended foods</i>, <i>Menus</i>, <i>News and Online resources</i>, <i>Practical tips</i>, <i>Mediterranean diet classroom</i>, and <i>Your personal experience</i>. 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; <i>P</i>&lt;.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (<i>P</i>&lt;.001), olive oil (<i>P</i>&lt;.001), whole grain cereals (<i>P</i>=.002), pulses (<i>P</i>&lt;.001), nuts (<i>P</i>&lt;.001), white fish (<i>P</i>&lt;.001), fatty fish (<i>P</i>&lt;.001), and white meat (<i>P</i>=.007), and a significant reduction in refined cereals (<i>P</i>&lt;.001), red and processed meat (<i>P</i>&lt;.001), and sweets (<i>P</i>&lt;.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (<i>P</i>&lt;.001) and fiber (<i>P</i>&lt;.001), and they decreased their intake of carbohydrates (<i>P</i>=.02) and saturated fatty acids (<i>P</i>&lt;.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. CLINICALTRIAL ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843

scholarly journals Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3597
Author(s):  
Patricia Salamanca-González ◽  
Rosa Maria Valls-Zamora ◽  
Anna Pedret-Figuerola ◽  
Mar Sorlí-Aguilar ◽  
Antoni Santigosa-Ayala ◽  
...  
Keyword(s):  
Social Networks ◽  
Lung Function ◽  
Respiratory Disease ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Improve Lung Function ◽  
Randomized Controlled ◽  
The Mediterranean

Background: Diet can help preserve lung function in smokers, as well as aid individuals who avoid smoking. This study aimed to evaluate the effectiveness of a nutritional intervention, using the Social Networks 2.0 tool, to increase adherence to the Mediterranean diet (MD) and improve lung function in smokers without prior respiratory disease. Methods: A randomized controlled parallel design was used. The participants were assigned to either the intervention or control group. Data from representative smokers without respiratory disease (n = 77) aged 18–70 years were analyzed. The participants completed a validated semi-quantitative food-frequency questionnaire, and their adherence to the diet was evaluated by using the questionnaire called the Mediterranean Diet Adherence Score (MEDAS, with 14 items), which considers ≥9 points to indicate high adherence. The lung function was assessed by spirometry. Associations among variables were determined by logistic regression. Results: A comparison of the variables at the end of the study between the control and intervention groups showed that the intervention significantly increased adherence to the MD based on the MEDAS questionnaire (0.69 (2.1) vs. 2.05 (2.03); p = 0.009). Specifically, the consumption of fruits was increased after two years in both groups; however, a more significant increase was detected in the intervention group (121 (178) vs. 12.7 (167) in the control group; p-value = 0.008). In the unadjusted analysis, the intervention only showed a statistical significant increase in the score of adherence to the MD (β: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (β: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (β: 1.17; 95% CI 0.02; 2.31; p = 0.046). The pulmonary function parameters improved more in the intervention group; however, no significant differences were observed between the two groups. Conclusions: A nutritional intervention based on a dietetic-nutritional education program resulted in a significant increase in adherence to the MD. However, some evidence suggests that an MD dietary intervention can improve lung function, but in our study, we were not able to demonstrate this. Further research is needed to obtain more robust data and confirm a possible benefit of the program before it can be extended to general practice.

scholarly journals Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study)

Nutrients ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 162 ◽  
Author(s):  
Rosario Alonso-Domínguez ◽  
Luis García-Ortiz ◽  
Maria Patino-Alonso ◽  
Natalia Sánchez-Aguadero ◽  
Manuel Gómez-Marcos ◽  
...  
Keyword(s):  
Mediterranean Diet ◽  
Diet Quality ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Multifactorial Intervention ◽  
The Mediterranean

The Mediterranean diet (MD) is recognized as one of the healthiest dietary patterns and has benefits such as improving glycaemic control among patients with type 2 diabetes (T2DM). Our aim is to assess the effectiveness of a multifactorial intervention to improve adherence to the MD, diet quality and biomedical parameters. The EMID study is a randomized and controlled clinical trial with two parallel groups and a 12-month follow-up period. The study included 204 subjects between 25–70 years with T2DM. The participants were randomized into intervention group (IG) and control group (CG). Both groups received brief advice about healthy eating and physical activity. The IG participants additionally took part in a food workshop, five walks and received a smartphone application for three months. The population studied had a mean age of 60.6 years. At the 3-month follow-up visit, there were improvements in adherence to the MD and diet quality of 2.2 and 2.5 points, compared to the baseline visit, respectively, in favour of the IG. This tendency of the improvement was maintained, in favour of the IG, at the 12-month follow-up visit. In conclusion, the multifactorial intervention performed could improve adherence to the MD and diet quality among patients with T2DM.

scholarly journals Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial

2021 ◽  
Author(s):  
María Barroso ◽  
M Dolors Zomeño ◽  
Jorge L Díaz ◽  
Silvia Pérez ◽  
Ruth Martí-Lluch ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiovascular Diseases ◽  
Mediterranean Diet ◽  
Controlled Trial ◽  
Intervention Group ◽  
Individual Risk ◽  
Control Group ◽  
Healthy Lifestyles ◽  
Randomized Controlled

Abstract Prevention is the key to stopping the ravages of cardiovascular diseases, the main cause of death worldwide. The objective was to analyze the efficacy of tailored recommendations to promote healthy lifestyles. Parallel-arm randomized controlled trial with 1 year follow-up. Individuals aged 35–74 years from Girona (Spain) randomly selected from a population with no cardiovascular diseases at baseline were included. Participants in the intervention group received a brochure with tailored healthy choices according to the individual risk profile and a trained nurse explained all recommendations in detail in a 30 min consultation. One year changes in smoking, Mediterranean diet adherence, physical activity, and weight were analyzed with McNemar, Student’s t, Wilcoxon, and Fisher exact tests according to an intention-to-treat strategy. Of 955 individuals (52.3% women; mean age 50 [±10] years) randomly allocated to the intervention or control group, one participant in each group presented a cardiovascular event and 768 (81%) were reexamined at 1 year follow-up. The prevalence of nonsmokers increased in both the intervention and control groups (78.1%–82.5%, p = &lt;.001, and 76.7% to 78.8%, p = .015, respectively); however, significance persisted only in the intervention group when stratified by sex, age group, and educational level. Adherence to a Mediterranean diet increased in the intervention group (22.3%–26.5%, p = .048). In conclusion, a brief personalized intervention with science-based recommendations according to individual risk profiles appears to improve healthy lifestyles, particularly nonsmoking and adherence to a Mediterranean diet. This promising intervention system offers evidence-based recommendations to develop healthy lifestyles.

Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomised clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Medical Care ◽  
Oral Anticoagulation ◽  
Intervention Group ◽  
Control Group ◽  
Motivational Intervention ◽  
Clinical Events ◽  
Secondary Outcomes

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range&lt;70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC&gt;80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p&lt;0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p&lt;0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None

scholarly journals Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Niklas Sörlén ◽  
Andreas Hult ◽  
Peter Nordström ◽  
Anna Nordström ◽  
Jonas Johansson
Keyword(s):  
Older Adults ◽  
Postural Sway ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Balance Exercise

Abstract Background We aimed to determine the effectiveness of 4 weeks of balance exercise compared with no intervention on objectively measured postural sway. Methods This was a single-center parallel randomized controlled, open label, trial. A six-sided dice was used for allocation at a 1:1-ratio between exercise and control. The trial was performed at a university hospital clinic in Sweden and recruited community-dwelling older adults with documented postural instability. The intervention consisted of progressively challenging balance exercise three times per week, during 4 weeks, with follow-up at week five. Main outcome measures were objective postural sway length during eyes open and eyes closed conditions. Results Sixty-five participants aged 70 years (balance exercise n = 32; no intervention n = 33) were randomized. 14 participants were excluded from analysis because of early dropout before follow-up at week five, leaving 51 (n = 22; n = 29) participants for analysis. No significant differences were detected between the groups in any of the postural sway outcomes. Within-group analyses showed significant improvements in hand grip strength for the intervention group, while Timed Up & Go improvements were comparable between groups but only statistically significant in the control group. Conclusions Performing balance exercise over a four-week intervention period did not acutely improve postural sway in balance-deficient older adults. The lower limit in duration and frequency to achieve positive effects remains unclear. Trial registration Clinical trials NCT03227666, July 24, 2017, retrospectively registered.

scholarly journals The Mediterranean Eating in Scotland Experience project: evaluation of an Internet-based intervention promoting the Mediterranean diet

2005 ◽  
Vol 94 (2) ◽  
pp. 290-298 ◽  
Author(s):  
Angeliki Papadaki ◽  
Jane A. Scott
Keyword(s):  
Nutrition Education ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Saturated Fat ◽  
Hdl Cholesterol ◽  
Control Group ◽  
Monounsaturated Fat ◽  
Feedback Intervention ◽  
Intention To Treat ◽  
The Mediterranean

A 6-month intervention study with a quasi-experimental design was conducted to evaluate the effectiveness of an Internet-based, stepwise, tailored-feedback intervention promoting four key components of the Mediterranean diet. Fifty-three (intervention group) and nineteen (control group) healthy females were recruited from the Universities of Glasgow and Glasgow Caledonian, Scotland, respectively. Participants in the intervention group received tailored dietary and psychosocial feedback and Internet nutrition education over a 6-month period, while participants in the control group were provided with minimal dietary feedback and general healthy-eating brochures. Internet education was provided via an innovative Mediterranean Eating Website. Dietary changes were assessed with 7 d estimated food diaries at baseline and 6 months, and data were analysed to calculate the Mediterranean Diet Score, a composite score based on the consumption of eight components of the traditional Mediterranean diet. The ‘intention-to-treat’ analyses showed that, at 6 months, participants in the intervention group had significantly increased their intake of vegetables, fruits and legumes, as well as the MUFA:saturated fatty acid ratio in their diet, and had significantly increased plasma HDL-cholesterol levels and a reduced ratio of total:HDL-cholesterol. Participants in the control group increased their intake of legumes but showed no other favourable significant changes compared with baseline. This Internet-based, tailored-feedback intervention promoting components of the Mediterranean diet holds promise in encouraging a greater consumption of plant foods, as well as increasing monounsaturated fat and decreasing saturated fat in the Scottish diet; it also shows that the Mediterranean diet can be adopted by healthy individuals in northern European countries.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals The Mediterranean diet protects against waist circumference enlargement in 12Ala carriers for the PPARγ gene: 2 years' follow-up of 774 subjects at high cardiovascular risk

2009 ◽  
Vol 102 (5) ◽  
pp. 672-679 ◽  
Author(s):  
Cristina Razquin ◽  
J. Alfredo Martinez ◽  
Miguel A. Martinez-Gonzalez ◽  
Dolores Corella ◽  
José Manuel Santos ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Waist Circumference ◽  
Mediterranean Diet ◽  
Nutritional Intervention ◽  
Control Group ◽  
Diabetic Patients ◽  
High Cardiovascular Risk ◽  
Pro12ala Polymorphism ◽  
The Mediterranean ◽  
Pparγ Gene

The PPARγ gene regulates insulin sensitivity and adipogenesis. The Pro12Ala polymorphism of this gene has been related to fat accumulation. Our aim was to analyse the effects of a 2-year nutritional intervention with Mediterranean-style diets on adiposity in high-cardiovascular risk patients depending on the Pro12Ala polymorphism of the PPARγ gene. The population consisted of a substudy (774 high-risk subjects aged 55–80 years) of the Prevención con Dieta Mediterránea (PREDIMED) randomised trial aimed at assessing the effect of the Mediterranean diet for CVD prevention. There were three nutritional intervention groups: two of them of a Mediterranean-style diet and the third was a control group advised to follow a conventional low-fat diet. All the participants were genotyped by PCR-restriction fragment length polymorphism (RFLP). The results showed that carriers of the 12Ala allele allocated to the control group had a statistically significant higher change in waist circumference (adjusted difference coefficient = 2·37 cm; P = 0·014) compared with wild-type subjects after 2 years of nutritional intervention. This adverse effect was not observed among 12Ala carriers allocated to both Mediterranean diet groups. In diabetic patients a statistically significant interaction between Mediterranean diet and the 12Ala allele regarding waist circumference change was observed ( − 5·85 cm; P = 0·003). In conclusion, the Mediterranean diet seems to be able to reduce waist circumference in a high-cardiovascular risk population, reversing the negative effect that the 12Ala allele carriers of the PPARγ gene appeared to have. The beneficial effect of this dietary pattern seems to be higher among type 2 diabetic subjects.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

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