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Personal Activity Intelligence e-Health Program in People with Type 2 Diabetes: A Pilot Randomized Controlled Trial.
Coombes, JS, Keating, SE, Mielke, GI, Fassett, RG, Coombes, BK, O'Leary, KP, Cox, ER, Burton, NW
Medicine and science in sports and exercise. 2022;(1):18-27
Abstract
INTRODUCTION Innovative strategies are needed to enable people with type 2 diabetes (T2D) to self-manage physical activity (PA). Personal Activity Intelligence (PAI) is a new metric that uses the heart rate response to PA to inform the user as to whether they are doing enough PA to reduce the risk of premature mortality. The PAI score reflects PA over the previous 7 d with the goal to maintain a score ≥100. The aim of this study was to investigate the feasibility, acceptability, and efficacy of the PAI e-Health Program in people with T2D. METHODS Thirty participants with T2D who were not meeting PA guidelines were randomly assigned to 12 wk of either 1) PAI e-Health Program or 2) PA attention control. The PAI e-Health Program consisted of receiving a wrist-worn heart rate monitor and an app with the PAI metric, and attending 4 × 2 h·wk-1 sessions of exercise and counseling. Feasibility and acceptability of the program were evaluated by achievement of a PAI score ≥100 and participant feedback. Efficacy was determined from changes in glycemic control, cardiorespiratory fitness, exercise capacity (time-on-test), body composition, sleep time, and health-related quality of life. RESULTS Program participants in the PAI e-Health Program had a mean ± SD PAI score of 119.7 ± 60.6 and achieved ≥100 PAI on 56.4% of the days. The majority of participants (80%) intended to continue to use PAI monitoring. Compared with control, the PAI group significantly improved their exercise capacity (mean difference, 95% confidence interval) (63 s, 17.9-108.0 s), sleep time (67.2 min, 7.2-127.1 min), total percent body fat (-1.3%, -2.6% to -0.1%), and gynoid fat percent (-1.5%, -2.6 to -0.5). CONCLUSIONS The PAI e-Health Program is feasible, acceptable, and efficacious in people with T2D.
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Efficacy of IVRS-based mHealth intervention in reducing cardiovascular risk in metabolic syndrome: A cluster randomized trial.
Sharma, AK, Baig, VN, Ahuja, J, Sharma, S, Panwar, RB, Katoch, VM, Gupta, R
Diabetes & metabolic syndrome. 2021;(5):102182
Abstract
AIMS: Efficacy of mobile-phone based intervention for reducing cardiovascular risk in metabolic syndrome (MetSyn). METHODS We screened adults 20-60 years in 10 villages in India for MetSyn using stratified cluster sampling. Lifestyle and biochemical risk factors were assessed. International Harmonized Criteria were used for diagnosis. Villages were randomized with 5 each in control and intervention groups. Interactive voice response system (IVRS) in Hindi was developed. In intervention clusters two messages for promotion of healthy lifestyle and medical treatment were broadcast daily over 12-months and risk factors reassessed. RESULTS 1012/1200(84%) persons were screened and MetSyn diagnosed in 286(28.3%). Villages were divided into 5 control(n = 136) and 5 intervention(n = 147) clusters. Baseline characteristics in both clusters were similar. Acceptability of intervention was >60% in 80% participants. At 12 months, significantly greater participants in intervention vs control clusters had healthier lifestyle (healthy diet 28.8vs14.7%, physical activity 25.9vs13.1%, tobacco 13.7vs32.5%), anthropometry (waist circumference 85.7 ± 6.3vs88.6 ± 14.0 cm, body mass index 21.9 ± 2.8vs23.1 ± 2.9 kg/m2), systolic BP 123.6 ± 7.7vs128.6 ± 14.1 mmHg, fasting glucose 95.6 ± 19.4vs109.4 ± 43.7 mg/dl, cholesterol 175.5 ± 36.5vs186.4 ± 43.3 mg/dl, and triglycerides 147.6 ± 48.3vs159.5 ± 60.7 mg/dl (p < 0.01). Prevalence of metabolic syndrome declined in intervention group by 22.3%vs3.9%, p < 0.001). CONCLUSION An interactive voice response system based technology significantly reduced multiple cardiovascular risk factors and prevalence of metabolic syndrome.
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Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial.
Reeves, MM, Terranova, CO, Winkler, EAH, McCarthy, N, Hickman, IJ, Ware, RS, Lawler, SP, Eakin, EG, Demark-Wahnefried, W
Nutrients. 2021;(11)
Abstract
Limited evidence exists on the effects of weight loss on chronic disease risk and patient-reported outcomes in breast cancer survivors. Breast cancer survivors (stage I-III; body mass index 25-45 kg/m2) were randomized to a 12-month, remotely delivered (22 telephone calls, mailed material, optional text messages) weight loss (diet and physical activity) intervention (n = 79) or usual care (n = 80). Weight loss (primary outcome), body composition, metabolic syndrome risk score and components, quality of life, fatigue, musculoskeletal pain, menopausal symptoms, fear of recurrence, and body image were assessed at baseline, 6 months, 12 months (primary endpoint), and 18 months. Participants were 55 ± 9 years and 10.7 ± 5.0 months post-diagnosis; retention was 81.8% (12 months) and 80.5% (18 months). At 12-months, intervention participants had significantly greater improvements in weight (-4.5% [95%CI: -6.5, -2.5]; p < 0.001), fat mass (-3.3 kg [-4.8, -1.9]; p < 0.001), metabolic syndrome risk score (-0.19 [-0.32, -0.05]; p = 0.006), waist circumference (-3.2 cm [-5.5, -0.9]; p = 0.007), fasting plasma glucose (-0.23 mmol/L [-0.44, -0.02]; p = 0.032), physical quality of life (2.7 [0.7, 4.6]; p = 0.007; Cohen's effect size (d) = 0.40), musculoskeletal pain (-0.5 [-0.8, -0.2]; p = 0.003; d = 0.49), and body image (-0.2 [-0.4, -0.0]; p = 0.030; d = 0.31) than usual care. At 18 months, effects on weight, adiposity, and metabolic syndrome risk scores were sustained; however, significant reductions in lean mass were observed (-1.1 kg [-1.7, -0.4]; p < 0.001). This intervention led to sustained improvements in adiposity and metabolic syndrome risk.
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Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.
Díaz-García, A, González-Robles, A, García-Palacios, A, Fernández-Álvarez, J, Castilla, D, Bretón, JM, Baños, RM, Quero, S, Botella, C
Journal of medical Internet research. 2021;(2):e21335
Abstract
BACKGROUND Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.
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Intervention Fidelity Focusing on Interaction between Participants and Facilitators in a Telephone-Delivered Health Coaching Intervention for the Prevention and Management of Type 2 Diabetes.
Timm, L, Karlsson, I, Sidney Annerstedt, K, Absetz, P, Forsberg, BC, Daivadanam, M, Mølsted Alvesson, H
Nutrients. 2021;(11)
Abstract
Self-management support and lifestyle interventions with an empowerment approach have been found to be effective strategies for health improvement among people at risk for or living with type 2 diabetes. Telephone coaching seems particularly efficient for individuals with low socioeconomic status and culturally and linguistically diverse backgrounds. In this mixed methods study, we investigate a telephone-delivered health coaching intervention provided by the diabetes project SMART2D (Self-Management Approach and Reciprocal learning for Type 2 Diabetes) implemented in socioeconomically disadvantaged areas in Stockholm, Sweden. We focus on the interaction between participants and facilitators as part of intervention fidelity. Recorded coaching sessions were scored using an interaction tool and analyzed by exploratory factor analysis and recorded supervisory discussions with facilitators analyzed using thematic analysis. The quantitative analysis showed that the intervention components were delivered as intended; however, differences between facilitators were found. The qualitative data highlighted differences between facilitators in the delivery, especially in relation to dietary and physical activity goalsetting. The level of language skills hindered the delivery flow and the tailoring of sessions to participants' needs led to different delivery styles. The interaction between facilitators and participants is an important aspect of intervention implementation. Tailoring of interventions is necessary, and language-skilled facilitators are needed to minimize barriers in intervention delivery.
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Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic.
Knoerl, R, Phillips, CS, Berfield, J, Woods, H, Acosta, M, Tanasijevic, A, Ligibel, J
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(8):4191-4194
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Abstract
The outbreak of the coronavirus disease 2019 (COVID-19) and subsequent need for disease transmission mitigation efforts have significantly altered the delivery of cancer care (e.g., rise of telemedicine), including within the field of integrative oncology. However, little has been described about how National Cancer Institute-Designated Cancer Centers have transformed integrative oncology care delivery in response to the COVID-19 pandemic. The purpose of this commentary is to describe the delivery of integrative oncology clinical services and conduct of research at The Leonard P. Zakim Center for Integrative Therapies and Healthy Living at Dana-Farber Cancer Institute during the COVID-19 pandemic. Clinical services transitioned from an array of in-person appointment-based services, such as acupuncture and massage, and group programs, such as yoga and nutrition seminars to a combination of live-streamed and on-demand virtual group programs and one-on-one virtual appointments for services such as acupressure and self-care massage. Group program volume grew from 2189 in-person program patient visits in the 6 months prior to onset of the COVID pandemic to 16,366 virtual (e.g., live-streamed or on-demand) patient visits in the first 6 months of the pandemic. From a research perspective, two integrative oncology studies, focused on yoga and music therapy, respectively, were transitioned from in-person delivery to a virtual format. Participant accrual to these studies increased after the transition to virtual consent and intervention delivery. Overall, our clinical and research observations at Dana-Farber Cancer Institute suggest that the delivery of virtual integrative oncology treatments is feasible and appealing to patients. Trial Registration: NCT03824860 (Yoga); NCT03709225 (Music Therapy).
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Group Lifestyle Phone Maintenance for Weight, Health, and Physical Function in Adults Aged 65-80 Years: A Randomized Clinical Trial.
Venditti, EM, Marcus, MD, Miller, RG, Arena, VC, Greenspan, SL, Rockette-Wagner, B
The journals of gerontology. Series A, Biological sciences and medical sciences. 2021;(2):352-360
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BACKGROUND Group lifestyle sessions with phone maintenance could improve weight, health, and function in vulnerable older adults. METHODS Community-dwelling adults (N = 322) with body mass index (BMI, kg/m2) ≥27 and additional risk factors received 12 one-hour in-person behavioral weight management group sessions then were randomized to 8 half-hour telephone sessions (n = 162) or newsletter control (n = 160) from 4 to 12 months with no treatment contact thereafter. Primary outcome was 0- to 12-month weight change. Cardiometabolic, short physical performance battery (SPPB), and self-reported activity changes were assessed at 12 and 24 months. RESULTS At baseline, the mean (SD) age was 71.2 (4.3) and BMI was 33.8 (5.1). Participants were 77% women, 13% Black, 85% retired, averaging 4 medical conditions, and taking blood pressure (67.4%) and lipid-lowering (51.6%) medications. At 12 months, a greater proportion of the phone group (66.0%) achieved ≥5% weight loss compared with newsletter control (53.2%; p = .02). Mean (95% CI) weight loss was greater for phone (-6.6 kg [-7.5, -5.8]) than newsletter (-5.1 kg [-7.2, -3.0]); p = .01. Modest lipid, glucose, and blood pressure improvements were found, but did not differ significantly between groups. Small SPPB and activity improvements were maintained at 12 and 24 months in both groups. CONCLUSIONS Brief phone contacts compared to newsletters enhanced weight loss maintenance among older high-risk adults at 1 year, but not cardiometabolic outcomes. Modest functional improvements were observed in both. Lower-intensity maintenance contacts (phone or newsletter) for weight, health, and physical function in older adults warrant further study. CLINICAL TRIALS REGISTRATION NUMBER NCT03192475.
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Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol.
Bernal-Jiménez, MÁ, Calle-Pérez, G, Gutiérrez-Barrios, A, Gheorghe, L, Solano-Mulero, AM, Rodríguez-Martín, A, Tur, JA, Vázquez-García, R, Santi-Cano, MJ
Nutrients. 2021;(6)
Abstract
Coronary heart disease is one of the main causes of morbimortality around the world. Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. The educative intervention, involving a follow-up and self-monitoring, will be performed using an online mHealth tool consisting of an application for mobile phones and tablets. The quantitative primary outcomes from the two groups will be compared using an analysis of covariance (ANCOVA) adjusted for age and gender. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of CVRFs, and outcomes after discharge in terms of the use of health services, emergency visits, cardiovascular events and readmissions.
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"In my age, we didn't have the computers": Using a complexity lens to understand uptake of diabetes eHealth innovations into primary care-A qualitative study.
Yu, CH, McCann, M, Sale, J
PloS one. 2021;(7):e0254157
Abstract
BACKGROUND Shared decision-making is a central component of person-centred care and can be facilitated with the use of patient decision aids (PtDA). Barriers and facilitators to shared decision-making and PtDA use have been identified, yet integration of PtDAs into clinical care is limited. We sought to understand why, using the concepts of complexity science. METHODS We conducted 60-minute in-depth interviews with patients with diabetes, primary care physicians, nurses and dietitians who had participated in a randomized controlled trial examining the impact of MyDiabetesPlan (an online goal-setting PtDA). Relying on a qualitative description approach, we used a semi-structured interview guide to explore participants' experiences with using MyDiabetesPlan and how it was integrated into the clinical encounter and clinical care. Audiotapes were transcribed verbatim, then coded independently by two analysts. FINDINGS 17 interviews were conducted (5 physicians, 3 nurses, 2 dietitians, 7 patients). Two themes were developed: (1) MyDiabetesPlan appeared to empower patients by providing tailored patient-important information which engaged them in decision-making and self-care. Patients' use of MyDiabetesPlan was however impacted by their competing medical conditions, other life priorities and socioeconomic context. (2) MyDiabetesPlan emphasized to clinicians a patient-centred approach that helped patients assume greater ownership for their care. Clinicians' use of MyDiabetesPlan was impacted by pre-existing clinical tools/workplans, workflow, technical issues, clinic administrative logistics and support, and time. How clinicians adapted to these barriers influenced the degree to which MyDiabetesPlan was integrated into care. CONCLUSIONS A complexity lens (that considers relationships between multiple components of a complex system) may yield additional insights to optimize integration of PtDA into clinical care. A complexity lens recognizes that shared decision-making does not occur in the vacuum of a clinical dyad (patient and clinician), and will enable us to develop a family of interventions that address the whole process, rather than individual components. TRIAL REGISTRATION ClinicalTrials.gov NCT02379078.
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Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating.
Hildebrandt, T, Michaeledes, A, Mayhew, M, Greif, R, Sysko, R, Toro-Ramos, T, DeBar, L
The American journal of psychiatry. 2020;(2):134-142
Abstract
OBJECTIVE Cognitive-behavioral therapy (CBT) has shown efficacy in the treatment of eating disorders. The authors conducted a randomized controlled telemedicine trial of CBT-guided self-help (CBT-GSH) assisted with a smartphone app, Noom Monitor, for binge eating with or without purging. They hypothesized that coach-delivered CBT-GSH telemedicine sessions plus Noom Monitor would yield greater reductions in symptoms of binge eating, purging, and eating disorders compared with standard care. METHODS Fifty-two-week outcomes for CBT-GSH plus Noom Monitor (N=114) were compared with outcomes for standard care (N=111) among members of an integrated health care system in the Pacific Northwest. Patients in the health system who met inclusion criteria were ≥18 years old, had a body mass index ≥18.5, met criteria for DSM-5 binge eating disorder or bulimia nervosa, had 12 months of continuous health care enrollment in Kaiser Permanente Northwest, and had a personal smartphone. Participants received eight CBT-GSH telemedicine sessions over 12 weeks administered by health coaches, and outcomes were assessed at baseline and at weeks 4, 8, 12, 26, and 52. The use of available treatment offered within the Kaiser Permanente health care system was permitted for participants assigned to standard care. RESULTS Participants who received CBT-GSH plus Noom Monitor reported significant reductions in objective binge-eating days (β=-0.66, 95% CI=-1.06, -0.25; Cohen's d=-1.46, 95% CI=-4.63, -1.09) and achieved higher rates of remission (56.7% compared with 30%; number needed to treat=3.74) at 52 weeks compared with participants in standard care, none of whom received any eating disorder treatment during the intervention period (baseline and weeks 1-12). Similar patterns emerged for compensatory behaviors (vomiting, use of laxatives, and excessive exercise; 76.3% compared with 56.8%; number needed to treat=5.11), eating disorder symptoms (body shape, weight, eating concerns, and dietary restraint), and clinical impairment (Cohen's d=-10.07, -2.15). CONCLUSIONS These results suggest that CBT-GSH plus Noom Monitor delivered via telemedicine by routine-practice health coaches in a nonacademic health care system yields reductions in symptoms and impairment over 52 weeks compared with standard care.