The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT.
The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70?years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC =12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system.
Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care.
ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.
Eating habits are established during childhood and track into adolescence and later in life. Given that these habits have a large public health impact and influence the increasing rates of childhood obesity worldwide, there is a need for effective, evidence-based prevention trials promoting healthy eating habits in the first 2?years of life. The aim of this study was to develop and evaluate the effect of an eHealth intervention called Food4toddlers, aiming to promote healthy dietary habits in toddlers by targeting parents' awareness of their child's food environment (i.e., how food is provided or presented) and eating environment (e.g., feeding practices and social interaction). This paper describes the rationale, development, and evaluation design of this project.
We developed a 6-month eHealth intervention, with the extensive user involvement of health care nurses and parents of toddlers. This intervention is in line with the social cognitive theory, targeting the interwoven relationship between the person, behavior, and environment, with an emphasis on environmental factors. The intervention website includes recipes, information, activities, and collaboration opportunities. The Food4toddlers website can be used as a mobile application. To evaluate the intervention, a two-armed pre-post-follow-up randomized controlled trial is presently being conducted in Norway. Parents of toddlers (n =?404) were recruited via social media (Facebook) and 298 provided baseline data of their toddlers at age 12?months. After baseline measurements, participants were randomly allocated to an intervention group or control group. Primary outcomes are the child's diet quality and food variety. All participants will be followed up at age 18?months, 2?years, and 4?years.
The results of this trial will provide evidence to increase knowledge about the effectiveness of an eHealth intervention targeting parents and their toddler's dietary habits.
ISRCTN92980420 . Registered 13 September 2017. Retrospectively registered.
Intimate partner violence (IPV) around the time of pregnancy is a recognized global health problem with damaging consequences. However, little is known about the effect of violence assessment and intervention during pregnancy. We hypothesise that routine enquiry about IPV during pregnancy, in combination with information about IPV and safety behaviours, has the potential to increase the use of these behaviours and prevent and reduce IPV.
The Safe Pregnancy study is a randomised controlled trial (RCT) to test the effectiveness of a tablet-based intervention to promote safety behaviours among pregnant women. Midwives include women who attend routine antenatal care. The intervention consists of a screening questionnaire for violence and information about violence and safety behaviours through a short video shown on a tablet. The materials are available in different languages to ensure participation of Norwegian, Urdu, Somali and English-speaking women. Eligible women answer baseline questions on the tablet including the Abuse Assessment Scale (AAS). Women who screen positive on the AAS will be randomized to an intervention video that contains information about violence and safety behaviours and women in the control group to a video with general information about a healthy and a safe pregnancy. All women receive information about referral resources. Follow up will be at three months post-partum, when the woman attends the maternal and child health centre (MCHC) for the baby's check-up. Outcome measures are: Use of safety behaviours and quality of life (primary outcomes), prevalence of violence, mental health measures and birth outcomes (secondary outcomes). Intention to treat analysis will be performed.
The project will provide evidence on whether enquiry about violence and a short video intervention on a tablet is effective and feasible to prevent or reduce harm from IPV among women who attend antenatal care.
This study is registered in ClinicalTrials.gov. Identifier: NCT03397277 (Registered 11th January 2018).
Atrial fibrillation is associated with increased mortality as well as morbidity. There is strong evidence for an association between atrial fibrillation and sleep apnea. It is not known whether treatment of sleep apnea with continuous positive airway pressure (CPAP) will reduce the burden of atrial fibrillation.
The Treatment of Sleep Apnea in Patients with Paroxysmal Atrial Fibrillation study will investigate the effects of CPAP in patients with paroxysmal atrial fibrillation and sleep apnea.
The trial has a dual center, randomized, controlled, open-label, parallel design.
Two centers will enroll a total of 100 patients with both paroxysmal atrial fibrillation and sleep apnea (apnea-hypopnea index [AHI]?=?15 events/h) who are scheduled for catheter ablation. Patients will be randomized in a 1:1 ratio to CPAP or control group (50 patients in each arm). The effects of CPAP treatment on atrial fibrillation will be determined using an implanted loop recorder (Reveal LINQ™, Medtronic) that detects all arrhythmia episodes. The primary endpoint is a reduction of the total burden of atrial fibrillation in the intervention group, after 5 months' follow-up (preablation). Reduction in the arrhythmia recurrence rate after ablation is the main secondary endpoint. All patients will be followed up for 12 months after ablation.
This study is the first randomized controlled trial that will provide data on the effects of CPAP therapy in patients with paroxysmal atrial fibrillation and sleep apnea. The results are expected to improve our understanding of the interaction between paroxysmal atrial fibrillation and sleep apnea. ClinicalTrials.gov Identifier. NCT02727192.
A primary concern within the healthcare system is to make treatment more accessible as well as attractive for the great majority of alcohol-dependent people who feel reluctant to participate in the treatment programs available. This paper presents the protocol for a randomized controlled trial (RCT) to test the efficacy of two different technical devices (mobile phone application and breathalyzer) on alcohol consumption.
The study is a three-armed RCT with follow-ups 3 and 6 months after randomization. In total, 375 adults (age 18+ years) diagnosed with alcohol use disorder (AUD) will be invited to participate in a 3-month intervention. The primary outcome is the number of days with heavy drinking, defined as four or more standard drinks (12 g alcohol/drink) and measured by the timeline follow back (TLFB) and Alcohol Use Disorder Identification Test (AUDIT) instruments at 3-month and 6-month follow-up. Secondary outcome measures include weekly alcohol consumption, measured by the TLFB, AUDIT, and phosphatidylethanol in blood values at 3-month and 6-month follow-up (number of days with blood alcohol concentration levels exceeding 60 mg/100 ml).
Improving ways of collecting data on alcohol consumption, as well as the treatment system with regards to AUD, is of vital importance. Mobile phone technology, with associated applications, is widely recognized as a potentially powerful tool in the prevention and management of disease. This study will provide unique knowledge regarding the use of new technology as instruments for measuring alcohol consumption and, also, as a possible way to decrease it.
ISRCTN, ISRCTN14515753 . Registered on 31 May 2018.