Web-Based Behavioral Intervention Research Articles

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial

Introduction: Behavioral activation (BA) is effective for the treatment of depression. The Health Action Process Approach (HAPA), which is derived from health psychology, can provide a motivational-volitional framework of BA. Objective: This study investigated the efficacy of a HAPA-based internet-delivered BA intervention (iBA; called InterAKTIV) in individuals with depression, also assessing HAPA-based motivational and volitional outcomes. Methods: In a two-arm randomized controlled efficacy trial with a parallel design, 128 participants with a major depressive episode were randomly allocated to the intervention group (IG; TAU + immediate access to iBA) or control group (CG; TAU + access to iBA after follow-up). The primary outcome of clinician-rated depressive symptoms and secondary outcomes were assessed at baseline (T1), 8 weeks (T2), 6-month after randomization (T3). Data were analyzed on an intention-to-treat basis. Results: Linear mixed model analyses revealed a significant group*time interaction effect on clinician-rated depressive symptoms favoring the IG (F_{2, 156.0} = 7.40; p < 0.001, d = 0.79 at T2, d = 0.25 at T3). The IG was also superior regarding self-rated depressive symptoms, BA, most motivational, and all volitional outcomes. Conclusion: This study shows that HAPA-based iBA can significantly improve clinician-rated depressive symptoms, as well as outcomes used in the HAPA model in people with depression. Building on these efficacy results, in the next step, the relationship between BA interventions and activity levels should be investigated, taking into account motivation and volition as potential mediators.

Adapting a Telephone-Based, Dyadic Self-management Program to Be Delivered Over the Web: Methodology and Usability Testing.

The COVID-19 pandemic has amplified the need for web-based behavioral interventions to support individuals who are diagnosed with chronic conditions and their informal caregivers. However, most interventions focus on patient outcomes. Dyadic technology-enabled interventions that simultaneously improve outcomes for patients and caregivers are needed. This study aimed to describe the methodology used to adapt a telephone-based, facilitated, and dyadic self-management program called Self-care Using Collaborative Coping Enhancement in Diseases (SUCCEED) into a self-guided, web-based version (web-SUCCEED) and to conduct usability testing for web-SUCCEED. We developed web-SUCCEED in 6 steps: ideation-determine the intervention content areas; prototyping-develop the wireframes, illustrating the look and feel of the website; prototype refinement via feedback from focus groups; finalizing the module content; programming web-SUCCEED; and usability testing. A diverse team of stakeholders including content experts, web designers, patients, and caregivers provided input at various stages of development. Costs, including full-time equivalent employee, were summarized. At the ideation stage, we determined the content of web-SUCCEED based on feedback from the program's original pilot study. At the prototyping stage, the principal investigator and web designers iteratively developed prototypes that included inclusive design elements (eg, large font size). Feedback about these prototypes was elicited through 2 focus groups of veterans with chronic conditions (n=13). Rapid thematic analysis identified two themes: (1) web-based interventions can be useful for many but should include ways to connect with other users and (2) prototypes were sufficient to elicit feedback about the esthetics, but a live website allowing for continual feedback and updating would be better. Focus group feedback was incorporated into building a functional website. In parallel, the content experts worked in small groups to adapt SUCCEED's content, so that it could be delivered in a didactic, self-guided format. Usability testing was completed by veterans (8/16, 50%) and caregivers (8/16, 50%). Veterans and caregivers gave web-SUCCEED high usability scores, noting that it was easy to understand, easy to use, and not overly burdensome. Notable negative feedback included "slightly agreeing" that the site was confusing and awkward. All veterans (8/8, 100%) agreed that they would choose this type of program in the future to access an intervention that aims to improve their health. Developing and maintaining the software and hosting together cost approximately US $100,000, excluding salary and fringe benefits for project personnel (steps 1-3: US $25,000; steps 4-6: US $75,000). Adapting an existing, facilitated self-management support program for delivery via the web is feasible, and such programs can remotely deliver content. Input from a multidisciplinary team of experts and stakeholders can ensure the program's success. Those interested in adapting programs should have a realistic estimate of the budget and staffing requirements.

Movement as Medicine for Cardiovascular Disease Prevention: Pilot Feasibility Study of a Physical Activity Promotion Intervention for At-Risk Patients in Primary Care.

BackgroundPhysical activity (PA) can reduce cardiovascular disease (CVD) risk factors, and although primary care settings offer a large reach to promote PA and reduce CVD risk, primary health care professionals may lack self-efficacy and tools to effectively promote PA in practice. Movement as Medicine for CVD Prevention is a suite of 2 theory-based, web-based behavioral interventions—one for health care professionals and one for patients—which may offer a pathway for promoting PA and reducing CVD risk in primary care.ObjectiveThis study aims to examine the feasibility and possible effects of Movement as Medicine for CVD Prevention.MethodsThis nonrandomized pilot study recruited participants from primary care organizations in the Northeast of England. Enrolled health care professionals followed a theory-based, web-based course on PA counseling and motivational interviewing techniques. After the course, health care professionals delivered behavior change consultations based on motivational interviewing to inactive individuals with >20% risk of developing CVD within 10 years. Patients were then given access to a website based on self-determination and self-regulation theories, which targeted increased levels of PA. Outcomes were assessed at baseline and after 3 months, and patient data were analyzed on an intention-to-treat basis in a multiple imputation data set.ResultsRecruitment rates of primary care organizations fell below expectations. A total of 11 health care professionals from 3 enrolled primary care organizations completed the web-based course and reported increases in important theoretical determinants of PA promotion in practice (eg, self-efficacy, Cohen d=1.24, 95% CI 0.67-1.80; and planning, Cohen d=0.85, 95% CI −0.01 to 1.69). A total of 83 patients were enrolled in the study, and 58 (70%) completed both the baseline and 3-month assessments. Compared with baseline, patients had higher levels of objective (Cohen d=0.77, 95% CI 0.13-1.41) but not subjective (Cohen d=0.40, 95% CI −0.03 to 0.83) moderate to vigorous PA at 3 months. Patients also reported higher levels of the PA determinants of intention, self-efficacy, intrinsic motivation, and action planning and action control at 3 months (effect sizes ranged from Cohen d=0.39 to 0.60).ConclusionsThe Movement as Medicine for CVD Prevention intervention seems to have the potential to improve patient PA behaviors and important determinants of health care professionals’ PA promotion practices. However, the recruitment rates of primary care organizations in this study were low and would need to be increased to examine the efficacy of the program. This study offers several insights into improving the feasibility of this primary care PA promotion pathway.Trial RegistrationISRCTN Registry ISRCTN14582348; http://www.isrctn.com/ISRCTN14582348

Protocol: A randomized controlled trial to assess effectiveness of a 12-month lifestyle intervention to reduce cardiovascular disease risk in families ten years after pre-eclampsia (FINNCARE)

Pre-eclampsia (PE) is a multisystem progressive disorder affecting 3–5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term. The effectiveness of a family-centered lifestyle intervention to lower CVD risk in PE families has not previously been evaluated. In the current FINNCARE study, we prospectively compare CVD risk and CVD progression in PE families (mother, father and child) in a cross-sectional study setting 8–12 years from delivery with non-PE control families of comparable age. Furthermore, we evaluate the effectiveness and feasibility of an interactive web-based behavioral 12-month lifestyle intervention to reduce blood pressure and the CVD risk profile overall in a randomized controlled trial. In total, 300 PE families will be randomized 1:1 to a PE-intervention or a PE-control group, and the 100 non-PE control families similarly followed-up at 12 months. Primary outcome is 24-hour mean systolic BP change from baseline in mother and child. Study aims to provide information on CVD progression and CVD risk management in the family following PE.

Effectiveness of a web-based behavioural activation intervention for individuals with depression based on the Health Action Process Approach: protocol for a randomised controlled trial with a 6-month follow-up

IntroductionBehavioural activation is a highly effective treatment for depression. However, there is considerable heterogeneity of interventions grouped under the term ‘behavioural activation’. A main reason for the heterogeneity is the...

Quality of Life of Prostate Cancer Survivors Participating in a Remotely Delivered Web-Based Behavioral Intervention Pilot Randomized Trial.

Background:Following a prostate cancer (PC) diagnosis, treatment-related symptoms may result in diminished quality of life (QoL). Improved diet and increased exercise may improve QoL in men with PC.Methods:We conducted a 4-arm pilot randomized trial to assess feasibility and acceptability of a 3-month web-based diet and exercise intervention, among men (>18 years of age) with PC (reported elsewhere). The purpose of this study is to describe the change in QoL measured by surveys (eg, QLQ-C30, PROMIS Fatigue) at enrollment and following the intervention. Men were randomized 1:1:1:1 to increasing levels of web-based behavioral support: Level 1: website; Level 2: Level 1 plus personalized diet and exercise prescription; Level 3: Levels 1-2 plus Fitbit and text messages; Level 4: Levels 1-3 plus 2 30-minute coaching calls. T-tests were used to compare pre-post change in mean QoL scores between each Level and Level 1.Results:Two hundred and two men consented and were randomized (n = 49, 51, 50, 52 for Levels 1-4, respectively). Men were predominantly white (93%), with a median age of 70 years (Intra-quartile Range [IQR]: 65,75) and 3 years (IQR: 1,9) post primary treatment for mostly localized disease (74% with T1-2). There were no meaningful changes in QoL, but there were notable trends. Level 3 participants had small improvements in QLQ-C30 Global Health (5.46; 95% CI: −0.02, 10.95) compared to Level 1. In contrast, Level 2 participants trended toward decreasing Global QoL (−2.31, 95% CI: −8.05, 3.42), which may reflect declines in function (eg, Cognitive: −6.94, 95% CI: −13.76, −0.13) and higher symptom burden (eg, Diarrhea: 4.63, 95% CI: −1.48, 10.74).Conclusions:This short, web-based intervention did not appear to have an impact on PC survivors’ QoL. Most men were several years past treatment for localized disease; the potential for this approach to reduce symptoms and improve QoL in men who have worse health may still be warranted.

Supporting Self-management Among Young People With Acne Vulgaris Through a Web-Based Behavioral Intervention: Development and Feasibility Randomized Controlled Trial.

Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. ISRCTN 78626638; https://tinyurl.com/n4wackrw.

Web-Based Behavioral Intervention Utilizing Narrative Persuasion for HIV Prevention Among Chinese Men Who Have Sex With Men (HeHe Talks Project): Intervention Development.

BackgroundIn the era of potent antiretroviral therapy, a high level of condomless anal intercourse continues to drive increases in HIV incidence in recent years among men who have sex with men. Effective behavior change strategies for promoting HIV-preventive behaviors are warranted. Narrative persuasion is a novel health communication approach that has demonstrated its persuasive advantages in overcoming resistance to counterattitudinal messages. The efficacy of narrative persuasion in promoting health behavior changes has been well documented, but critical research gaps exist for its application to HIV prevention.ObjectiveIn this study, we aimed to (1) capitalize on narrative persuasion to design a web-based multisession intervention for reducing condomless anal intercourse among men who have sex with men in Hong Kong (the HeHe Talks Project) by following a systematic development process; and (2) describe the main components of the narrative intervention that potentially determine its persuasiveness.MethodsPersuasive themes and subtopics related to reducing condomless anal intercourse were initially proposed based on epidemiological evidence. The biographic narrative interview method was used to elicit firsthand experiential stories from a maximum variation sample of local men who have sex with men with diverse backgrounds and experiences related to HIV prevention; different types of role models were established accordingly. Framework analysis was used to aggregate the original quotations from narrators into collective narratives under 6 intervention themes. A dedicated website was finally developed for intervention delivery.ResultsA series of video-based intervention messages in biographic narrative format (firsthand experiential stories shared by men who have sex with men) combined with topic-equivalent argumentative messages were produced and programmed into 6 intervention sessions. The 6-week intervention program can be automatically delivered and monitored online.ConclusionsWe systematically created a web-based HIV prevention intervention derived from peer-generated stories. Strategies used to enhance the efficacy of the narrative intervention have been discussed within basic communication components. This paper describes the methods and experiences of the rigorous development of a narrative communication intervention for HIV prevention, which enables replication of the intervention in the future.

Quality Of Life Of Prostate Cancer Survivors In A Web-based Behavioral Intervention Pilot Trial

Quality Of Life Of Prostate Cancer Survivors In A Web-based Behavioral Intervention Pilot Trial

Web-based behavioral intervention to reduce exposure to phthalate metabolites, bisphenol A, triclosan, and parabens in mothers with young children: A randomized controlled trial.

In this study, a web-based behavioral intervention was designed, which aimed to reduce exposure to phthalate metabolites, bisphenol A, triclosan, and parabens in mothers with young children. A randomized controlled design with two groups was used to verify the effects of the intervention pre- and post-test. In total, 51 mothers participated in the study, categorizing 26 and 25 in the intervention and control groups, respectively. The web-based behavioral intervention focused on changes in diet, personal care products, and health behavior and reinforced behavior through encouragement. This program included an educational video, a game for locating endocrine disruptors at home, a method for locating facilities potentially emitting endocrine disruptors, resources, and a questions and answers mode. Data were collected from May 18 to June 30, 2020. Participants allocated to the intervention group were provided access to the behavioral intervention website via a computer or smartphone. Participants allocated to the control group were sent written information about endocrine disruptors via mail. For both the intervention and control groups, questionnaire results and maternal urine samples were assessed at baseline, during the intervention, and after one month. After the intervention, the urinary concentrations of mono (2-ethylhexyl) phthalate (MEHP), mono (2-ethyl-5-oxohexyl) phthalate (MEOHP), bisphenol A (BPA), methylparaben (MP), ethylparaben (EP), and propylparaben (PP) were found to be significantly decreased in the intervention group. Compared with the control group, the intervention group showed significantly decreased urinary geometric mean values of MEHP, MEOHP, BPA, MP, and PP after one month compared with those during the intervention (3.8%, 16.3%, 28.4%, 9.2%, and 24.4%, respectively). Hence, the web-based behavioral intervention was effective at reducing the exposure to endocrine disruptors in mothers with young children.

Fidelity of Delivery and Contextual Factors Influencing Children's Level of Engagement: Process Evaluation of the Online Remote Behavioral Intervention for Tics Trial.

BackgroundThe Online Remote Behavioral Intervention for Tics (ORBIT) study was a multicenter randomized controlled trial of a complex intervention that consisted of a web-based behavioral intervention for children and young people with tic disorders. In the first part of a two-stage process evaluation, we conducted a mixed methods study exploring the reach, dose, and fidelity of the intervention and contextual factors influencing engagement.ObjectiveThis study aims to explore the fidelity of delivery and contextual factors underpinning the ORBIT trial.MethodsBaseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (N=112). The experiences of being in the intervention were explored through semistructured interviews with children (n=20) and parent participants (n=20), therapists (n=4), and referring clinicians (n=6). A principal component analysis was used to create a comprehensive, composite measure of children and young people’s engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices, including chapters accessed, number of pages visited, and number of log-ins. The engagement factor score was used as the dependent variable in a multiple linear regression analysis with various contextual variables as independent variables to assess if there were any significant predictors of engagement.ResultsThe intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. The engagement was high, with child participants completing an average of 7.5 of 10 (SD 2.7) chapters, and 88.4% (99/112) of participants completed the minimum of the first four chapters—the predefined threshold effective dose. Compared with the total population of children with tic disorders, participants in the sample tended to have more educated parents and lived in more economically advantaged areas; however, socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site versus the Nottingham site (P=.01), self-referred versus clinic referred (P=.04), higher parental engagement as evidenced by the number of parental chapters completed (n=111; ρ=0.73; P<.001), and more therapist time for parents (n=111; ρ=0.46; P<.001). A multiple linear regression indicated that parents’ chapter completion (β=.69; t110=10.18; P<.001) and therapist time for parents (β=.19; t110=2.95; P=.004) were the only significant independent predictors of child engagement factor scores.ConclusionsOverall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parents were strong predictors of intervention implementation, which has important implications for designing and implementing digital therapeutic interventions in child and adolescent mental health services.International Registered Report Identifier (IRRID)RR2-10.1186/s13063-019-3974-3

Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App.

BackgroundAlthough calorie tracking is one of the strongest predictors of weight loss in behavioral weight loss interventions, low rates of adherence are common. ObjectiveThis study aims to examine the feasibility and acceptability of using the Slip Buddy app during a 12-week web-based weight loss program. MethodsWe conducted a randomized pilot trial to evaluate the feasibility and acceptability of using the Slip Buddy app compared with a popular commercial calorie tracking app during a counselor-led, web-based behavioral weight loss intervention. Adults who were overweight or obese were recruited on the web and randomized into a 12-week web-based weight loss intervention that included either the Slip Buddy app or a commercial calorie tracking app. Feasibility outcomes included retention, app use, usability, slips reported, and contextual factors reported at slips. Acceptability outcomes included ratings of how helpful, tedious, taxing, time consuming, and burdensome using the assigned app was. We described weight change from baseline to 12 weeks in both groups as an exploratory outcome. Participants using the Slip Buddy app provided feedback on how to improve it during the postintervention focus groups. ResultsA total of 75% (48/64) of the participants were female and, on average, 39.8 (SD 11.0) years old with a mean BMI of 34.2 (SD 4.9) kg/m2. Retention was high in both conditions, with 97% (31/32) retained in the Slip Buddy condition and 94% (30/32) retained in the calorie tracking condition. On average, participants used the Slip Buddy app on 53.8% (SD 31.3%) of days, which was not significantly different from those using the calorie tracking app (mean 57.5%, SD 28.4% of days), and participants who recorded slips (30/32, 94%) logged on average 17.9 (SD 14.4) slips in 12 weeks. The most common slips occurred during snack times (220/538, 40.9%). Slips most often occurred at home (297/538, 55.2%), while working (153/538, 28.4%), while socializing (130/538, 24.2%), or during screen time (123/538, 22.9%). The conditions did not differ in participants’ ratings of how their assigned app was tedious, taxing, or time consuming (all values of P>.05), but the calorie tracking condition gave their app higher helpfulness and usability ratings (all values of P<.05). Technical issues were the most common type of negative feedback, whereas simplicity was the most common type of positive feedback. Weight losses of ≥5% of baseline weight were achieved by 31% (10/32) of Slip Buddy participants and 34% (11/32) of calorie tracking participants. ConclusionsSelf-monitoring of dietary lapses and the contextual factors associated with them may be an alternative for people who do not prefer calorie tracking. Future research should examine patient characteristics associated with adherence to different forms of dietary self-monitoring. Trial RegistrationClinicalTrials.gov NCT02615171; https://clinicaltrials.gov/ct2/show/NCT02615171

A novel method for assessing design fidelity in web-based behavioral interventions.

Delivery is one of the most common ways of assessing fidelity in behavioral interventions. However, there is a lack of research reporting on how well an intervention protocol reflects its proposed theoretical principles (design fidelity). This study presents a systematic method for assessing design fidelity and applies it to the eMotion web-based intervention targeting physical activity and depression. The eMotion intervention comprises of 13 web-based modules, designed according to an underlying intervention map. An independent rater with expertise in behavior change coded the presence or absence of behavior change techniques (BCTs) in the content of eMotion. Results of coding were compared to the intervention designers' a priori specification for interrater reliability. After discussion, the independent rater and the intervention designer had a high agreement for the presence of BCTs relating to behavioral activation (AC1 = 0.91) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). There was also high agreement for the presence of BCTs targeting physical activity (AC1 = 0.88) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). The eMotion description was then amended to align the interrater agreement. This study presents a novel method for assessing design fidelity. Developers of behavioral (and other multicomponent) interventions are encouraged to develop and refine this method and assess design fidelity in future interventions to ensure BCTs are operationalized as intended. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence).

BackgroundTo control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors.ObjectiveThis study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved.MethodsThis was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors.ResultsCurrent behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31).ConclusionsSelf-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

Supplemental Material for A Novel Method for Assessing Design Fidelity in Web-Based Behavioral Interventions

Supplemental Material for A Novel Method for Assessing Design Fidelity in Web-Based Behavioral Interventions

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.

BackgroundDiet and exercise may be associated with quality of life and survival in men with prostate cancer.ObjectiveThis study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer.MethodsWe conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls—one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes.ResultsIn total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1.ConclusionsA web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations.Trial RegistrationClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013

Be Healthe for Your Heart: A Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women with a History of Preeclampsia.

This pilot randomized controlled trial (RCT) aimed to determine the acceptability and preliminary efficacy of a web-based cardiovascular disease (CVD) prevention intervention for women following preeclampsia. Australian women with a recent history (≤4 years post diagnosis) of preeclampsia were randomized into two study arms: (1) Be Healthe for your Heart, a web-based behavioral intervention or; (2) Control, access to the National Heart Foundation website. Assessments were conducted at baseline, and after three months. Intervention acceptability and impact on absolute CVD 30-year risk score, CVD risk markers and health behaviors were assessed. Twenty-four of 31 (77.4%) women completed the three-month assessment. Eleven out of 13 intervention participants (84.6%) agreed/strongly agreed they were satisfied with the program, with a mean score of 4.2 ± 0.9 (maximum of five). There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months. Women with a history of preeclampsia were successfully recruited and retained and they reported high levels of acceptability with the Be Healthe for your Heart program. Further research is therefore needed from powered trials to determine the impact of web-based lifestyle interventions on CVD risk in this at-risk group.

Health Equity in the Effectiveness of Web-Based Health Interventions for the Self-Care of People With Chronic Health Conditions: Systematic Review.

BackgroundWeb-based self-care interventions have the potential to reduce health inequalities by removing barriers to access to health care. However, there is a lack of evidence about the equalizing effects of these interventions on chronic conditions.ObjectiveThis study investigated the differences in the effectiveness of web-based behavioral change interventions for the self-care of high burden chronic health conditions (eg, asthma, chronic obstructive pulmonary disease [COPD], diabetes, and osteoarthritis) across socioeconomic and cultural groups.MethodsA systematic review was conducted, following Cochrane review guidelines. We conducted searches in Ovid Medical Literature Analysis and Retrieval System Online and Cumulative Index to Nursing and Allied Health Literature databases. Studies with any quantitative design were included (published between January 1, 2006, and February 20, 2019) if they investigated web-based self-care interventions targeting asthma, COPD, diabetes, and osteoarthritis; were conducted in any high-income country; and reported variations in health, behavior, or psychosocial outcomes across social groups. Study outcomes were investigated for heterogeneity, and the possibility of a meta-analysis was explored. A narrative synthesis was provided together with a novel figure that was developed for this review, displaying heterogeneous outcomes.ResultsOverall, 7346 records were screened and 18 studies were included, most of which had a high or critical risk of bias. Important study features and essential data were often not reported. The meta-analysis was not possible due to the heterogeneity of outcomes. There was evidence that intervention effectiveness was modified by participants’ social characteristics. Minority ethnic groups were found to benefit more from interventions than majority ethnic groups. Single studies with variable quality showed that those with higher education, who were employed, and adolescents with divorced parents benefited more from interventions. The evidence for differences by age, gender, and health literacy was conflicting (eg, in some instances, older people benefited more, and in others, younger people benefited more). There was no evidence of differences in income, numeracy, or household size.ConclusionsThere was evidence that web-based self-care interventions for chronic conditions can be advantageous for some social groups (ie, minority ethnic groups, adolescents with divorced parents) and disadvantageous for other (ie, low education, unemployed) social groups who have historically experienced health inequity. However, these findings should be treated with caution as most of the evidence came from a small number of low-quality studies. The findings for gender and health literacy were mixed across studies on diabetes, and the findings for age were mixed across studies on asthma, COPD, and diabetes. There was no evidence that income, numeracy, or the number of people living in the household modified intervention effectiveness. We conclude that there appear to be interaction effects, which warrant exploration in future research, and recommend a priori consideration of the predicted interaction effects.Trial RegistrationPROSPERO CRD42017056163; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=56163

Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized Controlled Trial.

BackgroundInsufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants.ObjectiveThis study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting.MethodsThis was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity–promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity.ResultsThere was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3.ConclusionsThis study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity.Trial RegistrationClinicalTrials.gov NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

Be Healthe for Your Heart: Protocol for a Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women With a History of Preeclampsia.

Background: Women with a history of preeclampsia are at greater risk of cardiovascular disease (CVD) related morbidity. Despite this knowledge, there is a lack of interventions available for women with a history of preeclampsia for the prevention of CVD. The aim of this pilot randomized controlled trial (RCT) is to determine the acceptability and preliminary efficacy of a web-based behavioral intervention targeted to women with a history of preeclampsia (Be Healthe for your Heart).Method: Australian women aged 18–45 years, with a recent history (≤4 years post diagnosis) of preeclampsia will be recruited for a 3-months, 2-arm parallel group pilot RCT. Participants will be randomized into 2 study arms: (1) Be Healthe for your Heart or; (2) Control, with assessments conducted at baseline, and after 3-months. Be Healthe for your Heart is an intervention delivered online via the program website, with weekly emails to support changes in modifiable CVD risk factors (excess body weight, physical inactivity, poor diet, and stress), using behavior change techniques (e.g., self-monitoring, goal setting). Intervention acceptability (satisfaction, usability, appropriateness, and usage) and impact on absolute full CVD 30-years risk score, CVD risk markers, and modifiable risk factors will be assessed.Discussion: No studies to date have evaluated acceptability and preliminary efficacy of a web-based intervention for the prevention of CVD in this high-risk population with preeclampsia. This pilot trial will inform development of a fully powered RCT if acceptability and preliminary efficacy are demonstrated.