Associations between weight loss history and factors related to type 2 diabetes risk in the Stop Diabetes study

Background Frequent weight loss attempts are related to maladaptive eating behaviours and higher body mass index (BMI). We studied associations of several type 2 diabetes (T2D) risk factors with weight loss history, defined as the frequency of prior weight loss attempts, among Finnish adults at increased risk for T2D. Methods This study (n = 2684, 80% women) is a secondary analysis of the 1-year StopDia lifestyle intervention with digital intervention group, digital intervention + face-to-face counselling group, or control group. The frequency of prior weight loss attempts was categorized into five groups: no attempts/no attempts to lose weight, but trying to keep weight stable/1–2 attempts/3 or more attempts/ continuous attempts. Data on emotional eating and social/emotional nutrition self-efficacy were collected with a digital questionnaire. We assessed baseline differences between categories of weight loss history as well as the intervention effects. Results Altogether 84% of participants had attempted weight loss. Those with one or more weight loss attempts had higher BMI, larger waist circumference, and more emotional eating compared to ‘no attempts’ and ‘no attempts to lose weight, but trying to keep weight stable’ categories. The ‘no attempts’ category had the highest baseline fasting insulin, whereas it showed the largest decrease in this measure with the intervention. This change in fasting insulin in the ‘no attempts’ category was significantly different from all the other categories. Emotional nutrition self-efficacy slightly improved in the ‘no attempts’ category, which was significantly different from its concomitant decrease in the categories ‘1-2 attempts’ and ‘3 or more attempts’. The intervention group assignment did not affect the results. Conclusions Multiple attempts to lose weight may unfavourably affect T2D risk factors as well as lifestyle intervention outcomes. More research is needed on how weight loss frequency could affect T2D risk factors and how to design lifestyle interventions for individuals with frequent previous weight loss attempts.

Digital Health Interventions by Clinical Pharmacists: A Systematic Review

Integrating digital interventions in healthcare has gained increasing popularity among clinical pharmacists (CPs) due to advances in technology. The purpose of this study was to systematically review CP-led digital interventions to improve patients’ health-related clinical outcomes. PubMed and the Cochrane Database were searched to select studies that had conducted a randomized controlled trial to evaluate clinical outcomes in adults following a CP-led digital intervention for the period from January 2005 to August 2021. A total of 19 studies were included in our analysis. In these 19 studies, the most commonly used digital intervention by CPs was telephone use (n = 15), followed by a web-based tool (n = 2) and a mobile app (n = 2). These interventions were provided to serve a wide range of purposes in patients’ outcomes: change in lab values (e.g., blood pressure, HbA1c) (n = 23), reduction in health service use (n = 8), enhancing adherence (n = 6), improvement in drug-related outcomes (n = 6), increase in survival (n = 3), and reduction in health-related risk (e.g., CVD risk) (n = 2). Although the impacts of telephone-based interventions on patients’ outcomes were decidedly mixed, web-based interventions and mobile apps exerted generally positive influences. To date, little research has investigated the cost-effectiveness of digital interventions. Future studies are warranted.

Process Evaluation of MAPS: A Highly Tailored Digital Intervention to Support Medication Adherence in Primary Care Setting

Background: Medication adherence can prevent health risks, but many patients do not adhere to their prescribed treatment. Our recent trial found that a digital intervention was effective at improving medication adherence in non-adherent patients with Hypertension or Type 2 Diabetes; but we do not know how it brought about behavioural changes. This research is a post-trial process evaluation of the mechanism by which the intervention achieved its intended effects.Methods: A mixed methods design with quantitative and qualitative evidence synthesis was employed. Data was generated by two studies. Study 1 used questionnaires to measure the underlying mechanisms of and the medication adherence behaviour, and digital logfiles to objectively capture intervention effects on the process of behaviour change. Multilevel regression analysis on 57 complete intervention group cases tested the effects of the intervention at modifying the mechanism of behaviour change and in turn at improving medication adherence. Study 2 used in depth interviews with a subsample of 20 intervention patients, and eight practise nurses. Thematic analysis provided evidence about the overarching intervention functions and recommendations to improve intervention reach and impact in primary care.Results: Study 1 found that intervention effectiveness was significantly associated with positive changes in the underlying mechanisms of behaviour change (R2 = 0.26, SE = 0.98, P = 0.00); and this effect was heightened twofold when the tailored intervention content and reporting on medication taking (R2 = 0.59, SE = 0.74, P = 0.00) was interested into the regression model. Study 2 suggested that the intervention supported motivation and ability to adherence, although clinically meaningful effects would require very brief medication adherence risk appraisal and signposting to ongoing digitally delivered behavioural support during clinical consultations.Conclusion: This post trial process evaluation used objective methods to capture the intervention effect on the mechanisms of behaviour change to explain intervention effectiveness, and subjective accounts to explore the circumstances under which these effects were achieved. The results of this process evaluation will inform a large scale randomised controlled trial in primary care.

Digital Intervention for Problematic Smartphone Use

Smartphones have become the primary devices for accessing the online world. The potential for smartphone use to become problematic has come into increasing focus. Students and young adults have been shown to use their smartphones at high rates and may be at risk for problematic use. There is limited research evaluating interventions for problematic smartphone use. The present research aimed to develop and evaluate a digital intervention for problematic smartphone use in a student population. A mixed-method case series design was used. The participants were 10 students with mild–moderate dependency on the online world (measured via a self-report questionnaire). An intervention comprising goal setting, personalised feedback, mindfulness, and behavioural suggestions was delivered via a smartphone application. Time spent on smartphones was measured objectively through the same application. Changes in problematic technology use, wellbeing, mindfulness, and sleep were also evaluated. The findings indicate that the intervention resulted in a reduction in self-reported problematic smartphone use, but not screen time. The findings also indicate that over the course of participation, there was a positive influence on wellbeing, online dependency, mindfulness, and sleep. However, the mechanisms of change could not be determined. The study provides preliminary evidence that a light-touch, smartphone-delivered package is an acceptable and effective intervention for students wishing to better manage their problematic smartphone use.

Evaluation of the Immediate Effects of Digital Intervention Modules for Goals, Planning and Coping Planning on Physical Activity: Secondary Analysis of a Randomized Controlled Trial (Preprint)

BACKGROUND The use of digital interventions can be accurately monitored via log files. However, monitoring engagement with intervention goals or enactment of the actual behaviors targeted by the intervention is more difficult and is usually evaluated based on pre-post measurements in a controlled trial. OBJECTIVE To evaluate if engaging with two digital intervention modules focusing on physical activity goals and action plans, and coping with barriers had immediate effects on the actual physical activity behavior. METHODS The NoHoW Toolkit (TK) was a digital intervention developed for supporting long-term weight loss maintenance, evaluated in a 2 x 2 factorial randomized controlled trial. The TK contained various modules based on behavioral self-regulation and motivation theories, and contextual emotion regulation approaches, and involved continuous tracking of weight and physical activity through connected commercial devices (Fitbit Aria TM and Charge 2 TM). Two of the four trial arms had access to two modules directly targeting physical activity, i.e. a module for goal setting and action planning (“Goal”) and a module for identifying barriers and coping planning (“Barriers”). Module visits and completion were determined based on TK log files and time spent in the module web page. Five physical activity metrics (steps; activity; energy expenditure; fairly active, very active and total active minutes; and distance) were compared before and after visiting and completing the modules to examine whether the modules had immediate or sustained effects on physical activity. Immediate effect was determined based on 7-day windows before and after the visit, and sustained effects were evaluated for weeks 1-8 after module completion. RESULTS Out of the 811 participants, 498 (61.4%) visited the Goal module and 406 (50.1%) visited the Barriers module. The Barriers module had an immediate effect on very active and total active minutes (before-median for very active minutes: 24.2min/day, interquartile range IQR 10.4–43.0min vs. after: 24.9min, IQR 10.0–46.3min; P=.047; before-median for total active minutes: 45.1min/day, interquartile range IQR 22.9–74.9min vs. after: 46.9min, IQR 22.4–78.4min; P=.029). The differences were larger when only completed Barriers modules were considered. Barriers module completion was also associated with sustained effects in fairly active and total active minutes for most of the eight weeks following module completion, and for three weeks in very active minutes. CONCLUSIONS The Barriers module had small significant immediate and sustained effects on active minutes measured by a wrist-worn activity tracker. Future interventions should pay attention to assessing barriers and planning coping mechanisms to overcome them. CLINICALTRIAL ISRTCN registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328.

Developing a web-based self-management intervention for symptoms of fatigue, pain and urgency in Inflammatory Bowel Disease (Preprint)

BACKGROUND Empirical studies and systematic reviews demonstrate the role of biological, cognitive, behavioural and emotional factors in fatigue, pain and urgency in inflammatory bowel disease (IBD). Behavioural management that addresses the cognitive, behavioural and emotional factors, that is offered alongside medical treatments is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioural support to patients. OBJECTIVE This paper aims to describe the process of developing a supported digital self-management intervention for fatigue, pain and urgency in IBD using theory, evidence-based approaches and stakeholder input. METHODS The Medical Research Council framework for complex health interventions and the Person-Based Approach were used to guide intervention development consulting with 87 IBD patients and 60 nurses. These frameworks informed the selection and use of a theoretical model, which subsequently guided cognitive behaviourally-based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD, matched to predominant symptoms. RESULTS A trans-symptomatic cognitive behavioural framework of symptom perpetuation was developed for the symptoms of fatigue, pain and urgency in IBD. A logic model was used to define intervention techniques. Patient feedback and qualitative interviews refined website content and functionalities, including use of visual aids, email reminders and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery mode of therapist ‘facilitator’-support. Feasibility testing with 31 patients demonstrated accessibility (scoring 9.43/10), ease (scoring 8.07/10), clarity and relevant tone of the intervention. The final intervention consisted of 12 online sessions (8 core and 4 symptom-specific) with one 30-minute facilitator phone call following Session 1 and subsequent in-site messaging. CONCLUSIONS Use of theory and integration of stakeholders’ views throughout informed development of an evidence-based digital intervention for fatigue, pain and urgency in IBD. This is the first online self-management intervention designed to address these multiple symptoms with the aim of improving quality of life and reducing symptom burden in IBD. The intervention is being tested in a large multi-centre randomised controlled trial.