Clinical Trials and Publications
Our digital therapeutics have been evaluated in several clinical trials with positive results.
Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial
Sandborg J, Söderström E, Henriksson P, Bendtsen M, Henström M, Leppänen MH, Maddison R, Migueles JH, Blomberg M, Löf M
JMIR Mhealth Uhealth 2021;9(3):e26091
The aim of this randomized controlled trial was to investigate the effectiveness of the 6-month intervention (the HealthyMoms app) on gestational weight gain (primary outcome), body fatness, dietary habits (Swedish Healthy Eating Index), moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance (secondary outcomes) in gestational week 37 among Swedish women.
Patient interactive digital support for women with adjuvant endocrine therapy in order to increase compliance and quality of life
Bergqvist, J., Lundström, S. & Wengström, Y.
Support Care Cancer (2020)
The primary aim of the study was to develop and investigate a patient interactive digital support (an app) for patients on adjuvant endocrine breast cancer treatment. The app was tested by patients and improved further before a pilot study was completed in which 15 patients used the app for 3 months. The app was perceived easy to use and of support in every-day life of breast cancer survivors.
Mobile-based intervention intended to stop obesity in preschool-aged children: the MINISTOP randomized controlled trial
Christine Delisle Nyström, Sven Sandin, Pontus Henriksson, Hanna Henriksson, Ylva Trolle-Lagerros, Christel Larsson, Ralph Maddison, Francisco B Ortega, Jeremy Pomeroy, Jonatan R Ruiz, Kristin Silfvernagel, Toomas Timpka, Marie Löf
Am J Clin Nutr 2017
The goal of MINISTOP was to help parents of children aged 4 y to achieve a healthy weight and body fat via a smartphone application. More specifically, this trial aimed to reduce body fat (primary outcome) and to improve the intake of fruits, vegetables, candy, and sweetened beverages and the amount of time spent sedentary and in moderate-to-vigorous physical activity (MVPA) (secondary outcomes) in 315 healthy Swedish children aged 4.5 y.
Effects of interactive patient smartphone support app on drug adherence and lifestyle changes in myocardial infarction patients: A randomized study
Am Heart J 2016;178:85-94
A total of 174 ticagrelor-treated Myocardial Infarction (MI) patients were randomized to either an interactive patient support tool (active group) or a simplified tool (control group) in addition to usual post-MI care. Primary end point was a composite nonadherence score measuring patient-registered ticagrelor adherence, defined as a combination of adherence failure events (2 missed doses registered in 7-day cycles) and treatment gaps (4 consecutive missed doses). Secondary end points included change in cardiovascular risk factors, quality of life (European Quality of Life–5 Dimensions), and patient device satisfaction (System Usability Scale).
A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial
BMC Public Health 2015, 15:95
A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline).
Estimating physical activity using a cell phone questionnaire sent by means of short message service (SMS): a randomized population-based study
European Journal of Epidemiology – 2012 Jul;27(7):561-6.
doi: 10.1007/s10654-012-9708-4. Epub 2012 Jun 29.
An investigation in a randomized populationbased Swedish study with 564 participants aged 18–80 years showed that mean physical activity levels obtained using short message service (SMS) by means of cell phones (n = 171) were equal to corresponding levels obtained when sending identical questions by web (n = 182) or paper (n = 211). The response rates were similar for the SMS, web and paper groups.
Estimation of Physical Activity Levels Using Cell Phone Questionnaires: A Comparison With Accelerometry for Evaluation of Between-Subject and Within-Subject Variations
J Med Internet Res 2011;13(3):e70)
Physical activity promotes health and longevity. Further elaboration of the role of physical activity for human health in epidemiological studies on large samples requires accurate methods that are easy to use, cheap, and possible to repeat. The use of telecommunication technologies such as cell phones is highly interesting in this respect. In an earlier report, we showed that physical activity level (PAL) assessed using a cell phone procedure agreed well with corresponding estimates obtained using the doubly labeled water method. However, our earlier study indicated high within-subject variation in relation to between-subject variations in PAL using cell phones, but we could not assess if this was a true variation of PAL or an artifact of the cell phone technique.
Our objective was to compare within- and between-subject variations in PAL by means of cell phones with corresponding estimates using an accelerometer. In addition, we compared the agreement of daily PAL values obtained using the cell phone questionnaire with corresponding data obtained using an accelerometer.
J Med Internet Res 2010;12(1):e2)
Physical activity is associated with reduced risks of many chronic diseases. Data collected on physical activity in large epidemiological studies is often based on paper questionnaires. The validity of these questionnaires is debated, and more effective methods are needed.
This study evaluates repeated measures of physical activity level (PAL) and the feasibility of using a Java-based questionnaire downloaded onto cell phones for collection of such data. The data obtained were compared with reference estimates based on the doubly labeled water method and indirect calorimetry (PALref).