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Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial.
Duncan, MJ, Fenton, S, Brown, WJ, Collins, CE, Glozier, N, Kolt, GS, Holliday, EG, Morgan, PJ, Murawski, B, Plotnikoff, RC, et al
International journal of environmental research and public health. 2020;(17)
Abstract
BACKGROUND This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. METHODS Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. RESULTS Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups. CONCLUSIONS Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.
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Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.
Taylor, AH, Taylor, RS, Ingram, WM, Anokye, N, Dean, S, Jolly, K, Mutrie, N, Lambert, J, Yardley, L, Greaves, C, et al
Health technology assessment (Winchester, England). 2020;(63):1-106
Abstract
BACKGROUND There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. OBJECTIVES To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. DESIGN A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). SETTING Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. PARTICIPANTS There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. INTERVENTION e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. PRIMARY OUTCOME MEASURE Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. SECONDARY OUTCOMES Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. RESULTS Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. LIMITATIONS A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. FUTURE WORK The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. CONCLUSIONS Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. TRIAL REGISTRATION Current Controlled Trials ISRCTN15644451. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.
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E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.
Feigerlová, E, Oussalah, A, Zuily, S, Sordet, S, Braun, M, Guéant, JL, Guerci, B
Diabetes/metabolism research and reviews. 2020;(6):e3313
Abstract
AIMS: Patient-centered education improves glycemic control in subjects with type 1 diabetes (T1D). E-health technologies are widely used to support medical decision-making, patient advising or teleconsultations; however, the active participation of a patient is missing. Challenges remain whether e-health education can be effectively incorporated into clinical pathways. The purpose of the study was to examine the effects of e-health education, compared to standard care, on HbA1c. MATERIAL AND METHODS We conducted a literature search (EMBASE, MEDLINE, The Cochrane Library and Web of Science) up to February 2018 for randomized controlled trials (RCTs) of Internet-/ mobile application-based educational interventions, with the active involvement of patients, provided in addition to, or substituting usual care in patients with T1D on intensive insulin therapy. The primary outcome was the standardized difference in means (SDM) of HbA1c change from baseline between intervention and comparator groups. RESULTS Eight RCTs involving 757 subjects were included on 6335 screened citations. After excluding two trials with a high risk of bias from the meta-analysis, the HbA1c change from baseline did not significantly differ between intervention and comparator groups (SDM = -0.154, 95% CI: -0.335 to 0.025; P = 0.01, random-effect model). The number of studies is limited with a relatively short duration. Reporting of educational outcomes was not rigorous. CONCLUSIONS The effect of e-health educational interventions on HbA1c in patients with T1D is comparable to the standard care. This review highlights the need for further well-designed RCTs that will investigate the opportunities of incorporating e-health education into clinical pathways.
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Can Instagram be used to deliver an evidence-based exercise program for young women? A process evaluation.
Curtis, RG, Ryan, JC, Edney, SM, Maher, CA
BMC public health. 2020;(1):1506
Abstract
BACKGROUND Instagram provides an opportunity to deliver low cost, accessible and appealing physical activity content. This study evaluated the feasibility of delivering an exercise program for young women using Instagram. METHODS A single-group pre- and post-intervention trial examined the feasibility and preliminary efficacy of a 12-week Instagram-delivered program with young inactive women (n = 16; M = 23 years), which prescribed running and body weight exercises to complete three times per week. Daily Instagram posts delivered the exercises, video demonstrations and motivational content. Feasibility was evaluated by examining exposure (Instagram posts viewed per week), engagement (likes, comments and tags on Instagram posts; number of exercise sessions completed per week; retention, defined as completion of the online survey at weeks 6 and 12), and acceptability [whether the program increased participants' motivation to exercise (1 = strongly disagree-5 = strongly agree); satisfaction with the program (1 = not satisfied-5 = very satisfied)]. Preliminary efficacy was evaluated by comparing baseline and 12-week self-reported physical activity (IPAQ short-form) and fitness (cardiorespiratory and muscle strength; 1 = very poor-5 = very good, International Fitness Scale) using the Exact sign test. RESULTS On average, participants reported seeing six posts in their Instagram feed per week. Posts received an average of five likes (IQR = 3-6). A total of four comments and one tag were observed across all posts. On average, participants reported completing two exercise sessions per week. Retention was 88% at 6 weeks but dropped to 56% at 12 weeks. Participants reported increased motivation to exercise (Mdn = 4, IQR = 3-4) and were satisfied with the program (Mdn = 4, IQR = 3-4). Only self-reported cardiorespiratory fitness showed a meaningful, though nonsignificant, improvement (MdnΔ = 1, IQR = 0-1, p = .06). CONCLUSIONS Although Instagram has the potential to deliver a low cost, convenient exercise program for young women, additional research is needed to identify methods of improving engagement (interaction with the Instagram content, exercise sessions completed, and retention in the program). Future research could examine the use of behaviour change theory and provide information that enables participants to tailor the exercises to their interests and needs. Additionally, the use of objective assessments of physical activity and fitness among a larger participants sample is needed.
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A Narrative Literature Review and Environmental Scan of Self-management Education Programs for Adolescent and Young Adult Survivors of Childhood Cancer.
Kobe, CM, Turcotte, LM, Sadak, KT
Journal of cancer education : the official journal of the American Association for Cancer Education. 2020;(4):731-735
Abstract
Self-management education programs (SMEPs) have demonstrated a measurable benefit in enhancing self-efficacy, increasing health knowledge, and improving both health behaviors and physical symptoms associated with underlying conditions in multiple chronic disease populations. Adolescent and young adult (AYA) survivors of childhood cancer, defined as individuals ages 15 to 39 years, are at a high risk for adverse health outcomes due to late complications from previous cancer treatments, knowledge deficits of their risks, and complex socioeconomic challenges associated with transitional periods in their lives. We performed a literature review and environmental scan to systematically survey and interpret relevant SMEPs to identify opportunities for their development specific to the AYA population. Despite evidence existing for the importance of self-management and general educational messages for survivors of childhood cancer, very few evidence-based interventions have been developed for the AYA population. Most SMEPs for cancer survivors are geared towards individuals with cancer in adulthood. Among the limited interventions directed at survivors of childhood cancer, they are focused on individual health behaviors, such as physical exercise, mental health, nutrition, or self-efficacy. Given the ever-growing technological footprint in our daily lives, mobile health (mHealth) applications may be the most efficacious means of delivering self-management education to this specific population. As content is developed through mHealth applications as well as other platforms, they will need to be rigorously evaluated, given their potential to compliment survivor-focused care.
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Usability of an Intelligent Virtual Assistant for Promoting Behavior Change and Self-Care in Older People with Type 2 Diabetes.
Balsa, J, Félix, I, Cláudio, AP, Carmo, MB, Silva, ICE, Guerreiro, A, Guedes, M, Henriques, A, Guerreiro, MP
Journal of medical systems. 2020;(7):130
Abstract
In the context of the VASelfCare project, we developed an application prototype of an intelligent anthropomorphic virtual assistant. Designed as a relational agent, the virtual assistant has the role of supporting older people with Type 2 Diabetes Mellitus (T2D) in medication adherence and lifestyle changes. Our paper has two goals: describing the essentials of this prototype, and reporting on usability evaluation. We describe the general architecture of the prototype, including the graphical component, and focus on its main feature: the incorporation, in the way the dialogue flows, of Behavior Change Techniques, identified through a theoretical framework, the Behaviour Change Wheel. Usability was experimentally evaluated in field tests in a purposive sample of 20 participants (11 older adults with T2D and 9 experts). The Portuguese version of the System Usability Scale was employed, supplemented with qualitative data from open questions, diaries, digital notes and telephone follow-ups. The aggregated mean SUS score was 73,75 (SD 13,31), which corresponds to a borderline rating of excellent. Textual data were content analyzed and will be prioritized to further improve usability.
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Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial.
Liu, S, Tanaka, R, Barr, S, Nolan, RP
Patient education and counseling. 2020;(3):635-641
Abstract
OBJECTIVE 1) Evaluate the efficacy of e-Counseling vs. Control to promote lifestyle behaviors at 4 and 12-month follow-ups, 2) examine whether these behaviors changes were associated with lower blood pressure (BP), and Framingham Risk Index (FRI) at 12-month. METHODS Hypertensive patients (n = 264) were randomized to the e-Counseling or the Control group. Primary trial outcome was BP and secondary outcomes included exercise and diet behaviors. This study presented the results of secondary outcomes. Linear mixed models evaluated treatment effects at 4 and 12-month. Treatment-by-sex exploratory analyses were conducted if no main treatment effect was observed. RESULTS Daily steps significantly improved in e-Counseling vs. Controls at 12-month. Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months. Improvements in steps and dietary sodium were significantly associated with improvements in BP and FRI at 12-month. CONCLUSION This hypertension e-Counseling protocol can promote long-term lifestyle behavior changes. Adherence to the lifestyle behavior change was associated with BP and FRI reduction at 12-month. PRACTICE IMPLICATIONS The hypertension e-counseling protocol has the potential to improve hypertension care and intervention reach.
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Mobile Health App With Social Media to Support Self-Management for Patients With Chronic Kidney Disease: Prospective Randomized Controlled Study.
Li, WY, Chiu, FC, Zeng, JK, Li, YW, Huang, SH, Yeh, HC, Cheng, BW, Yang, FJ
Journal of medical Internet research. 2020;(12):e19452
Abstract
BACKGROUND Chronic kidney disease (CKD) is a global health burden. Self-management plays a key role in improving modifiable risk factors. OBJECTIVE The aim of this study was to evaluate the effectiveness of wearable devices, a health management platform, and social media at improving the self-management of CKD, with the goal of establishing a new self-management intervention model. METHODS In a 90-day prospective experimental study, a total of 60 people with CKD at stages 1-4 were enrolled in the intervention group (n=30) and control group (n=30). All participants were provided with wearable devices that collected exercise-related data. All participants maintained dietary diaries using a smartphone app. All dietary and exercise information was then uploaded to a health management platform. Suggestions about diet and exercise were provided to the intervention group only, and a social media group was created to inspire the participants in the intervention group. Participants' self-efficacy and self-management questionnaire scores, Kidney Disease Quality of Life scores, body composition, and laboratory examinations before and after the intervention were compared between the intervention and control groups. RESULTS A total of 49 participants completed the study (25 in the intervention group and 24 in the control group); 74% of the participants were men and the mean age was 51.22 years. There were no differences in measured baseline characteristics between the groups except for educational background. After the intervention, the intervention group showed significantly higher scores for self-efficacy (mean 171.28, SD 22.92 vs mean 142.21, SD 26.36; P<.001) and self-management (mean 54.16, SD 6.71 vs mean 47.58, SD 6.42; P=.001). Kidney Disease Quality of Life scores were also higher in the intervention group (mean 293.16, SD 34.21 vs mean 276.37, SD 32.21; P=.02). The number of steps per day increased in the intervention group (9768.56 in week 1 and 11,389.12 in week 12). The estimated glomerular filtration rate (eGFR) of the intervention group was higher than that of the control group (mean 72.47, SD 24.28 vs mean 59.69, SD 22.25 mL/min/1.73m2; P=.03) and the decline in eGFR was significantly slower in the intervention group (-0.56 vs -4.58 mL/min/1.73m2). There were no differences in body composition between groups postintervention. CONCLUSIONS The use of wearable devices, a health management platform, and social media support not only strengthened self-efficacy and self-management but also improved quality of life and a slower eGFR decline in people with CKD at stages 1-4. These results outline a new self-management model to promote healthy lifestyle behaviors for patients with CKD. TRIAL REGISTRATION ClinicalTrials.gov NCT04617431; https://www.clinicaltrials.gov/ct2/show/NCT04617431.
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A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.
Ferrara, A, Hedderson, MM, Brown, SD, Ehrlich, SF, Tsai, AL, Feng, J, Galarce, M, Marcovina, S, Catalano, P, Quesenberry, CP
The lancet. Diabetes & endocrinology. 2020;(6):490-500
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Abstract
BACKGROUND Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity. METHODS We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m2, and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232. FINDINGS Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed. INTERPRETATION Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions. FUNDING US National Institutes of Health.
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Experiences of a National Web-Based Heart Age Calculator for Cardiovascular Disease Prevention: User Characteristics, Heart Age Results, and Behavior Change Survey.
Bonner, C, Raffoul, N, Battaglia, T, Mitchell, JA, Batcup, C, Stavreski, B
Journal of medical Internet research. 2020;(8):e19028
Abstract
BACKGROUND Heart age calculators are used worldwide to engage the public in cardiovascular disease (CVD) prevention. Experimental studies with small samples have found mixed effects of these tools, and previous reports of population samples that used web-based heart age tools have not evaluated psychological and behavioral outcomes. OBJECTIVE This study aims to report on national users of the Australian heart age calculator and the follow-up of a sample of users. METHODS The heart age calculator was launched in 2019 by the National Heart Foundation of Australia. Heart age results were calculated for all users and recorded for those who signed up for a heart age report and an email follow-up over 10 weeks, after which a survey was conducted. CVD risk factors, heart age results, and psychological and behavioral questions were analyzed using descriptive statistics and chi-square tests. Open responses were thematically coded. RESULTS There were 361,044 anonymous users over 5 months, of which 30,279 signed up to receive a heart age report and 1303 completed the survey. There were more women (19,840/30,279, 65.52%), with an average age of 55.67 (SD 11.43) years, and most users knew blood pressure levels (20,279/30,279, 66.97%) but not cholesterol levels (12,267/30,279, 40.51%). The average heart age result was 4.61 (SD 4.71) years older than the current age, including (23,840/30,279, 78.73%) with an older heart age. For the survey, most users recalled their heart age category (892/1303, 68.46%), and many reported lifestyle improvements (diet 821/1303, 63.01% and physical activity 809/1303, 62.09%). People with an older heart age result were more likely to report a doctor visit (538/1055, 51.00%). Participants indicated strong emotional responses to heart age, both positive and negative. CONCLUSIONS Most Australian users received an older heart age as per international and UK heart age tools. Heart age reports with follow-up over 10 weeks prompted strong emotional responses, high recall rates, and self-reported lifestyle changes and clinical checks for more than half of the survey respondents. These findings are based on a more engaged user sample than previous research, who were more likely to know blood pressure and cholesterol values. Further research is needed to determine which aspects are most effective in initiating and maintaining lifestyle changes. The results confirm high public interest in heart age tools, but additional support is needed to help users understand the results and take appropriate action.