Dataset Information

A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population's specific needs. The online intervention "MyPlan 2.0" targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population.

Objective

The aim of this paper is to thoroughly describe "MyPlan 2.0" and the study protocol that will be used to test the effectiveness of this intervention to alter patients' levels of physical activity and sedentary behavior.

Methods

A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients' stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted.

Results

The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019.

Conclusions

This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time.

International registered report identifier (irrid)

DERR1-10.2196/12413.

SUBMITTER: Poppe L

PROVIDER: S-EPMC6450483 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

Poppe Louise L De Bourdeaudhuij Ilse I Verloigne Maïté M Degroote Laurent L Shadid Samyah S Crombez Geert G

JMIR research protocols 20190322 3

<h4>Background</h4>Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population's specific needs. The online intervention "MyPlan 2.0" targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in ...[more]

PMID: 30901002

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Project description:BackgroundChronic diseases are the principal cause of morbidity and mortality worldwide. An increased consumption of vegetables and fruit reduces the risk of hypertension, coronary heart disease, stroke, and cancer. An increased fruit and vegetable (FV) intake may also prevent body weight gain, and therefore indirectly affect type 2 diabetes mellitus. Insufficient physical activity (PA) has been identified as the fourth leading risk factor for global mortality. Consequently, effective interventions that promote PA and FV intake in a large number of people are required.ObjectiveTo describe the systematic development of an eHealth intervention, MyPlan 1.0, for increasing FV intake and PA.MethodsThe intervention was developed following the six steps of the intervention mapping (IM) protocol. Decisions during steps were based upon available literature, focus group interviews, and pilot studies.ResultsBased on needs assessment (Step 1), it was decided to focus on fruit and vegetable intake and physical activity levels of adults. Based on self-regulation and the health action process approach model, motivational (eg, risk awareness) and volitional (eg, action planning) determinants were selected and crossed with performance objectives into a matrix with change objectives (Step 2). Behavioral change strategies (eg, goal setting, problem solving, and implementation intentions) were selected (Step 3). Tablet computers were chosen for delivery of the eHealth program in general practice (Step 4). To facilitate implementation of the intervention in general practice, GPs were involved in focus group interviews (Step 5). Finally, the planning of the evaluation of the intervention (Step 6) is briefly described.ConclusionsUsing the IM protocol ensures that a theory- and evidence-based intervention protocol is developed. If the intervention is found to be effective, a dynamic eHealth program for the promotion of healthy lifestyles could be available for use in general practice.

Project description:BackgroundeHealth interventions can reach large populations and are effective in increasing physical activity (PA) and fruit and vegetable intake. Nevertheless, the effects of eHealth interventions are overshadowed by high attrition rates. Examining more closely when users decide to leave the intervention can help eHealth developers to make informed decisions about which intervention components should be reshaped or simply removed. Investigating which users are more likely to quit an intervention can inform developers about whether and how their intervention should be adapted to specific subgroups of users.ObjectiveThis study investigated the pattern of attrition in a Web-based intervention to increase PA, fruit, and vegetable intake. The first aim was to describe attrition rates according to different self-regulation components. A second aim was to investigate whether certain user characteristics are predictors for start session completion, returning to a follow-up session and intervention completion.MethodsThe sample consisted of 549 adults who participated in an online intervention, based on self-regulation theory, to promote PA and fruit and vegetable intake, called "MyPlan 1.0." Using descriptive analysis, attrition was explored per self-regulation component (eg, action planning and coping planning). To identify which user characteristics predict completion, logistic regression analyses were conducted.ResultsAt the end of the intervention program, there was an attrition rate of 78.2% (330/422). Attrition rates were very similar for the different self-regulation components. However, attrition levels were higher for the fulfillment of questionnaires (eg, to generate tailored feedback) than for the more interactive components. The highest amount of attrition could be observed when people were asked to make their own action plan. There were no significant predictors for first session completion. Yet, two subgroups had a lower chance to complete the intervention, namely male users (OR: 2.24, 95% CI=1.23-4.08) and younger adults (OR: 1.02, 95% CI=1.00-1.04). Furthermore, younger adults were less likely to return to the website for the first follow-up after one week (OR: 1.03, 95% CI=1.01-1.04).ConclusionsThis study informs us that eHealth interventions should avoid the use of extensive questionnaires and that users should be provided with a rationale for several components (eg, making an action plan and completing questions). Furthermore, future interventions should focus first on motivating users for the behavior change before guiding them through action planning. Though, this study provides no evidence for removal of one of the self-regulation techniques based on attrition rates. Finally, strong efforts are needed to motivate male users and younger adults to complete eHealth interventions.

Project description:BackgroundAdopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA).ObjectiveThis study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years.MethodsThe study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples.ResultsIn RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out.ConclusionsFor both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes.Trial registrationClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146.International registered report identifier (irrid)RR2-10.2196/12413.

Project description:BackgroundPatients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support.ObjectiveThis feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States.MethodsPatients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention.ResultsOf the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls.ConclusionWe did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact.Trial registrationClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).

Project description:BackgroundSufficient physical activity and a limited amount of sedentary behaviour can prevent a range of chronic diseases. However, most adults do not meet the recommendations for physical activity and sedentary behaviour. Effective and engaging interventions are needed to change people's behaviour. E- and m-health interventions are promising, but unfortunately they result in small effects and suffer from high attrition rates. Improvements to intervention content and design are required. Qualitative research has revealed the need for clear and concise interventions. Furthermore, many interventions use a range of behaviour-change techniques, and it is yet unknown whether these techniques are equally important to obtain behaviour change. It may well be that a limited set of these techniques is sufficient. In this study, the aim is to experimentally investigate the efficacy of three behaviour-change techniques (i.e. action planning, coping planning and self-monitoring) on physical activity, sedentary behaviour and related determinants among adults.MethodsIn a 2 x 2 x 2 factorial trial participants will be randomly allocated to eight groups (including one control group). Each group will receive a different version of the self-regulation-based e- and m-health intervention 'MyPlan 2.0', in which three behaviour-change techniques (i.e. action planning, coping planning, self-monitoring) will be combined in order to achieve self-formulated goals about physical activity or sedentary behaviour. Goal attainment, and levels of physical activity and sedentary behaviour will be measured via self-report questionnaires.DiscussionThis study should provide insight into the role of various behaviour-change techniques in changing health behaviour and its determinants. Its experimental and longitudinal design, with repeated measures of several determinants of behaviour change, allows an in-depth analysis of the processes underlying behaviour change, enabling the authors to provide guidance for the development of future e- and m-health interventions.Trial registrationThis study is registered as MyPlan 2.0 as a clinical trial (ID number: NCT03274271 ). Release date: 20 October 2017.

Project description:IntroductionGestational diabetes mellitus (GDM) is increasingly becoming a serious public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their condition and prevent adverse obstetric and neonatal outcomes as well as later morbidity are required. This study aims to evaluate whether a novel, multilingual and scalable mobile health (mHealth) intervention (SPARK; SmartPhone App for gestational diabetes patients suppoRting Key lifestyle behaviours and glucose control) can improve self-management and treatment of GDM and prevent adverse maternal and offspring outcomes.Methods/analysesSPARK is a multicentre two-arm randomised controlled trial recruiting women diagnosed with GDM in south-eastern Sweden. A total of 412 women will be randomised to either standard care (control) or the SPARK intervention. The SPARK online platform (accessed through a mobile app) provides a behaviour change programme for healthy eating, physical activity and glycaemic control. To increase reach, SPARK is available in Swedish, English, Arabic and Somali. SPARK also comes with a clinician portal where healthcare professionals monitor and intervene when glycaemic control is unsatisfactory (above certain cut-offs). Primary outcomes are glycaemic control that is, time in range and HbA1c, while diet, physical activity (ActiGraph), gestational weight gain, metabolic and inflammatory biomarkers in weeks 37-38, adherence to protocol for daily glucose sampling, as well as adverse obstetric and neonatal outcomes are secondary outcomes. Secondary outcomes also include cardiometabolic risk evaluation, physical activity and healthy eating behaviours 1 year postpartum. A health economic evaluation of SPARK vs standard care will also be conducted.Ethics and disseminationThis study has been approved by the Swedish Ethical Review Authority (2021-06627-01; 2022-03842-02; 2023-05911-02). Results will be disseminated through scientific papers in peer-reviewed journals, posts in traditional and social media, and presentations at scientific and healthcare professionals' conferences.Trial registration numberThis trial was registered at the ClinicalTrials.gov register platform (ID NCT05348863) 27 April 2022.

Project description:BackgroundeHealth interventions show stronger effects when informed by solid behavioral change theories; for example, self-regulation models supporting people in translating vague intentions to specific actions have shown to be effective in altering health behaviors. Although these theories inform developers about which behavioral change techniques should be included, they provide limited information about how these techniques can be engagingly implemented in Web-based interventions. Considering the high levels of attrition in eHealth, investigating users' experience about the implementation of behavior change techniques might be a fruitful avenue.ObjectiveThe objective of our study was to investigate how users experience the implementation of self-regulation techniques in a Web-based intervention targeting physical activity and sedentary behavior in the general population.MethodsIn this study, 20 adults from the general population used the intervention for 5 weeks. Users' website data were explored, and semistructured interviews with each of the users were performed. A directed content analysis was performed using NVivo Software.ResultsThe techniques "providing feedback on performance," "action planning," and "prompting review of behavioral goals" were appreciated by users. However, the implementation of "barrier identification/problem solving" appeared to frustrate users; this was also reflected by the users' website data-many coping plans were of poor quality. Most users were well aware of the benefits of adopting a more active way of living and stated not to have learned novel information. However, they appreciated the provided information because it reminded them about the importance of having an active lifestyle. Furthermore, prompting users to self-monitor their behavioral change was not sufficiently stimulating to make users actually monitor their behavior.ConclusionsIteratively involving potential end users offers guidance to optimally adapt the implementation of various behavior change techniques to the target population. We recommend creating short interventions with a straightforward layout that support users in creating and evaluating specific plans for action.

Project description:BackgroundAdvancements in mobile technology have paved the way for innovative interventions aimed at promoting physical activity (PA).ObjectiveThe main objective of this feasibility study was to assess the feasibility, usability, and acceptability of the More In Action (MIA) app, designed to promote PA among older adults. MIA offers 7 features: personalized tips, PA literacy, guided peer workouts, a community calendar, a personal activity diary, a progression monitor, and a chatbot.MethodsOur study used a mixed methods approach to evaluate the MIA app's acceptability, feasibility, and usability. First, a think-aloud method was used to provide immediate feedback during initial app use. Participants then integrated the app into their daily activities for 5 weeks. Behavioral patterns such as user session duration, feature use frequency, and navigation paths were analyzed, focusing on engagement metrics and user interactions. User satisfaction was assessed using the System Usability Scale, Net Promoter Score, and Customer Satisfaction Score. Qualitative data from focus groups conducted after the 5-week intervention helped gather insights into user experiences. Participants were recruited using a combination of web-based and offline strategies, including social media outreach, newspaper advertisements, and presentations at older adult organizations and local community services. Our target group consisted of native Dutch-speaking older adults aged >65 years who were not affected by severe illnesses. Initial assessments and focus groups were conducted in person, whereas the intervention itself was web based.ResultsThe study involved 30 participants with an average age of 70.3 (SD 4.8) years, of whom 57% (17/30) were female. The app received positive ratings, with a System Usability Scale score of 77.4 and a Customer Satisfaction Score of 86.6%. Analysis showed general satisfaction with the app's workout videos, which were used in 585 sessions with a median duration of 14 (IQR 0-34) minutes per day. The Net Promoter Score was 33.34, indicating a good level of customer loyalty. Qualitative feedback highlighted the need for improvements in navigation, content relevance, and social engagement features, with suggestions for better calendar visibility, workout customization, and enhanced social features. Overall, the app demonstrated high usability and satisfaction, with near-daily engagement from participants.ConclusionsThe MIA app shows significant potential for promoting PA among older adults, evidenced by its high usability and satisfaction scores. Participants engaged with the app nearly daily, particularly appreciating the workout videos and educational content. Future enhancements should focus on better calendar visibility, workout customization, and integrating social networking features to foster community and support. In addition, incorporating wearable device integration and predictive analytics could provide real-time health data, optimizing activity recommendations and health monitoring. These enhancements will ensure that the app remains user-friendly, relevant, and sustainable, promoting sustained PA and healthy behaviors among older adults.Trial registrationClinicalTrials.gov NCT05650515; https://clinicaltrials.gov/study/NCT05650515.

Dataset Information

A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

International registered report identifier (irrid)

Publications

A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

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