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Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.

ABSTRACT: BACKGROUND:Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN). OBJECTIVE:The aim of this study is to investigate the short- and long-term efficacy, in terms of body composition and BP parameters, of a self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating) in patients who are obese with HTN. METHODS:A randomized wait-list controlled trial design was used. We recruited 105 adults with HTN who were overweight or obese and randomly assigned them to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). We assessed BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention). All the patients in the wait-list control group subsequently received the intervention, and a secondary within-group analysis, which also included these participants, was conducted at Time 2 (12-month follow-up). RESULTS:A 2-way mixed analysis of covariance showed a significant decrease in BMI, BFM, and blood glucose at 3 months in the internet-based intervention group; the effect size for the BMI and BFM parameters was moderate to large, and there was also a borderline significant trend for DBP and insulin. These results were either maintained or improved upon at Time 2 and showed significant changes for BMI (mean difference -0.4, 95% CI -0.1 to -0.6; P=.005), BFM (mean difference -2.4, 95% CI -1.1 to -3.6; P<.001), DBP (mean difference -1.8, 95% CI -0.2 to -3.3; P=.03), and blood glucose (mean difference -2, 95% CI 0 to -4; P=.04). CONCLUSIONS:Implementation of our self-administered internet-based intervention, which involved different learning techniques aimed to promote lifestyle changes, resulted in positive short- and long-term health benefits in patients who are obese with HTN. TRIAL REGISTRATION:ClinicalTrials.gov NCT03396302; https://clinicaltrials.gov/ct2/show/NCT03396302.

SUBMITTER: Lison JF

PROVIDER: S-EPMC7189251 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.

Lisón Juan Francisco JF Palomar Gonzalo G Mensorio Marinna S MS Baños Rosa M RM Cebolla-Martí Ausiàs A Botella Cristina C Benavent-Caballer Vicent V Rodilla Enrique E

Journal of medical Internet research 20200414 4

<h4>Background</h4>Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN) ...[more]

PMID: 32286232

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Project description:Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program.New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support.ClinicalTrials.gov NCT02289014 .

Project description:Purpose Being diagnosed with cancer causes major psychological distress; however, a majority of patients lack psychological support during this critical period. Internet interventions help patients overcome many barriers to seeking face-to-face support and may thus close this gap. We assessed feasibility and efficacy of Web-based stress management (STREAM [Stress-Aktiv-Mindern]) for newly diagnosed patients with cancer. Patients and Methods In a randomized controlled trial, patients with cancer who had started first-line treatment within the previous 12 weeks were randomly assigned to a therapist-guided Web-based intervention or a wait-list (control), stratified according to distress level (≥ 5 v < 5 on scale of 0 to 10). Primary efficacy end point was quality of life after the intervention (Functional Assessment of Chronic Illness Therapy-Fatigue). Secondary end points included distress (Distress Thermometer) and anxiety or depression (Hospital Anxiety and Depression Scale). Treatment effect was assessed with analyses of covariance, adjusted for baseline distress. Results A total of 222 of 229 screened patients applied online for participation. Between September 2014 and November 2016, 129 newly diagnosed patients with cancer, including 92 women treated for breast cancer, were randomly assigned to the intervention (n = 65) or control (n = 64) group. Adherence was good, with 80.0% of patients using ≥ six of eight modules. Psychologists spent 13.3 minutes per week (interquartile range, 9.5-17.9 minutes per week) per patient for online guidance. After the intervention, quality of life was significantly higher (Functional Assessment of Chronic Illness Therapy-Fatigue: mean, 8.59 points; 95% CI, 2.45 to 14.73 points; P = .007) and distress significantly lower (Distress Thermometer: mean, -0.85; 95% CI, -1.60 to -0.10; P = .03) in the intervention group as compared with the control. Changes in anxiety or depression were not significant in the intention-to-treat population (Hospital Anxiety and Depression Scale: mean, -1.28; 95% CI, -3.02 to 0.45; P = .15). Quality of life increased in the control group with the delayed intervention. Conclusion The Web-based stress management program STREAM is feasible and effective in improving quality of life.

Project description:BackgroundParticipation in outdoor play has been extensively documented as beneficial for the health, well-being, and development of children. Canadian early childhood education centers (ECECs) are important settings in young children's lives and provide opportunities to participate in outdoor play. However, there are barriers to the provision of outdoor play opportunities at ECECs, such as adverse weather conditions, poorly designed outdoor spaces, outdoor time policies, and early childhood educator comfort levels.ObjectiveThe PROmoting Early Childhood Outside (PRO-ECO) study is a wait-list control cluster randomized trial that evaluates the impact of the PRO-ECO intervention, an innovative outdoor play intervention, on children's outdoor play behavior. The purpose of this paper was to provide a detailed overview of the pilot study protocol and the methods that will be used to develop, implement, and evaluate the PRO-ECO intervention.MethodsA total of 8 ECECs delivering licensed care to children aged 2.5 to 6 years in the Greater Vancouver region of British Columbia, Canada, and operated by the YMCA of Greater Vancouver (YMCA GV) are included in this study. Using a wait-list control cluster randomized trial design, we randomly allocated ECECs to either the PRO-ECO intervention arm (n=4) or the wait-list control arm (n=4). The primary outcome measures include changes in the proportion and diversity of observed outdoor play behavior during dedicated outdoor times at the ECECs as measured through observational behavior mapping. Secondary outcome measures include changes in educator attitudes; quality of ECECs' outdoor play space; and children's psychosocial strengths, physical activity levels, and social behaviors. A process evaluation of the acceptability of the PRO-ECO intervention in the 8 YMCA GV ECECs will also be assessed. Outcome data will be collected at baseline, 6-month follow-up, and 12-month follow-up. Mixed effect models will test the effect of the PRO-ECO intervention on quantitative outcomes. Baseline and postintervention data will be included in the analysis, controlling for the cluster design. Qualitative data will support quantitative findings and provide evidence for the acceptability of implementation.ResultsParticipant recruitment for this study began in August 2021, and baseline data collection was completed at all 8 ECECs in November 2021. As of April 2022, a total of 130 children have been recruited to participate in this study.ConclusionsThe PRO-ECO pilot study will develop, implement, and evaluate the PRO-ECO intervention within 8 YMCA GV ECECs in the Vancouver region of British Columbia, Canada. The findings of this study will be useful for early childhood educators, ECEC providers, and policy makers to consider means for enhancing outdoor play provision and assessing the sustainability of the intervention in ECEC settings.Trial registrationClinicalTrials.gov NCT05075580; https://clinicaltrials.gov/ct2/show/NCT05073380.International registered report identifier (irrid)DERR1-10.2196/38365.

Project description:BackgroundInformal family caregivers constitute an important and increasingly demanding role in the cancer healthcare system. This is especially true for caregivers of patients with primary malignant brain tumors based on the rapid progression of disease, including physical and cognitive debilitation. Informal social network resources such as friends and family can provide social support to caregivers, which lowers caregiver burden and improves overall quality of life. However, barriers to obtaining needed social support exist for caregivers. To address this need, our team developed and is assessing a multi-component caregiver support intervention that uses a blend of technology and personal contact to improve caregiver social support.MethodsWe are currently conducting a prospective, longitudinal 2-group randomized controlled trial which compares caregivers who receive the intervention to a wait-list control group. Only caregivers directly receive the intervention, but the patient-caregiver dyads are enrolled so we can assess outcomes in both. The 8-week intervention consists of two components: (1) The electronic Social Network Assessment Program, a web-based tool to visualize existing social support resources and provide a tailored list of additional resources; and (2) Caregiver Navigation, including weekly phone sessions with a Caregiver Navigator to address caregiver social support needs. Outcomes are assessed by questionnaires completed by the caregiver (baseline, 4-week, 8-week) and the cancer patient (baseline, and 8-week). At 8 weeks, caregivers in the wait-list condition may opt into the intervention. Our primary outcome is caregiver well-being; we also explore patient well-being and caregiver and patient health care utilization.DiscussionThis protocol describes a study testing a novel social support intervention that pairs a web-based social network visualization tool and resource list (eSNAP) with personalized caregiver navigation. This intervention is responsive to a family-centered model of care and calls for clinical and research priorities focused on informal caregiving research.Trial registrationclinicaltrials.gov , Registration number: NCT04268979 ; Date of registration: February 10, 2020, retrospectively registered.

Project description:BackgroundPeople increase their risk of melanoma unless they are protected from the harmful effects of sun exposure during childhood and adolescence. We aimed to assess the feasibility of a three-component sun protection intervention- presentation, action planning, and SMS messages - and trial parameters.MethodsThis feasibility wait-list trial was conducted in the United Kingdom in 2018. Students aged 13-15?years were eligible. Feasibility outcomes were collected for recruitment rates; data availability rates for objective measurements of melanin and erythema using a Mexameter and self-reported sunburn occurrences, severity and body location, tanning, sun protection behaviours and Skin Self-Examination (SSE) collected before (baseline) and after the school summer holidays (follow-up); intervention reach, adherence, perceived impact and acceptability. Quantitative data were analysed using descriptive statistics; qualitative data were analysed thematically.ResultsFive out of eight schools expressing an interest in participating with four allocated to act as intervention and one control. Four parents/carers opted their child out of the study. Four hundred and eighty-seven out of 724 students on the school register consented to the study at baseline (67%). Three hundred and eighty-five were in intervention group schools. Objective skin measurements were available for 255 (66%) of the intervention group at baseline and 237 (61%) of the group at follow up. Melanin increased; erythema decreased. Complete self-report data were available for 247 (64%) students in the intervention group. The number of students on the school register who attended the presentation and given the booklet was 379 (98%) and gave their mobile phone number was 155 (40%). No intervention component was perceived as more impactful on sun protection behaviours. Adolescents did not see the relevance of sun protection in the UK or for their age group.ConclusionsThis is the first study to use a Mexameter to measure skin colour in adolescents. Erythema (visible redness) lasts no more than three days and its measurement before and after a six week summer holiday may not yield relevant or meaningful data. A major challenge is that adolescents do not see the relevance of sun protection and SSE.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN11141528. Date registered 0/2/03/2018; last edited 31/05/2018. Retrospectively registered.

Dataset Information

Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.

Publications

Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.

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