Randomized Trial for Weight Loss Using a Digital Therapeutic Application

2021 ◽  
pp. 193229682110008
Author(s):  
Tryggvi Thorgeirsson ◽  
Johanna E. Torfadottir ◽  
Erlendur Egilsson ◽  
Saemundur Oddsson ◽  
Thrudur Gunnarsdottir ◽  
...  
Keyword(s):  
Weight Loss ◽  
Mobile Application ◽  
Intervention Group ◽  
Lifestyle Change ◽  
Noncommunicable Diseases ◽  
Control Group ◽  
Intention To Treat ◽  
Protocol Group ◽  
Lifestyle Program ◽  
Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

School-based obesity interventions in the metropolitan area of Rio De Janeiro, Brazil: pooled analysis from five randomised studies

2021 ◽  
pp. 1-7
Author(s):  
Renata da R. M. Rodrigues ◽  
Bruna K. Hassan ◽  
Michele R. Sgambato ◽  
Bárbara da S. N. Souza ◽  
Diana B. Cunha ◽  
...  
Keyword(s):  
Eating Habits ◽  
Intervention Group ◽  
Pooled Analysis ◽  
Control Group ◽  
Intention To Treat ◽  
School Year ◽  
School Based ◽  
Obesity Interventions ◽  
The One ◽  
And Control

Abstract School-based studies, despite the large number of studies conducted, have reported inconclusive results on obesity prevention. The sample size is a major constraint in such studies by requiring large samples. This pooled analysis overcomes this problem by analysing 5926 students (mean age 11·5 years) from five randomised school-based interventions. These studies focused on encouraging students to change their drinking and eating habits, and physical activities over the one school year, with monthly 1-h sessions in the classroom; culinary class aimed at developing cooking skills to increase healthy eating and attempts to family engagement. Pooled intention-to-treat analysis using linear mixed models accounted for school clusters. Control and intervention groups were balanced at baseline. The overall result was a non-significant change in BMI after one school year of positive changes in behaviours associated with obesity. Estimated mean BMI changed from 19·02 to 19·22 kg/m2 in the control group and from 19·08 to 19·32 kg/m2 in the intervention group (P value of change over time = 0·09). Subgroup analyses among those overweight or with obesity at baseline also did not show differences between intervention and control groups. The percentage of fat measured by bioimpedance indicated a small reduction in the control compared with intervention (P = 0·05). This large pooled analysis showed no effect on obesity measures, although promising results were observed about modifying behaviours associated with obesity.

scholarly journals Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Patient Experience ◽  
Mobile Application ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
P Value ◽  
Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

scholarly journals The Mediterranean Eating in Scotland Experience project: evaluation of an Internet-based intervention promoting the Mediterranean diet

2005 ◽  
Vol 94 (2) ◽  
pp. 290-298 ◽  
Author(s):  
Angeliki Papadaki ◽  
Jane A. Scott
Keyword(s):  
Nutrition Education ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Saturated Fat ◽  
Hdl Cholesterol ◽  
Control Group ◽  
Monounsaturated Fat ◽  
Feedback Intervention ◽  
Intention To Treat ◽  
The Mediterranean

A 6-month intervention study with a quasi-experimental design was conducted to evaluate the effectiveness of an Internet-based, stepwise, tailored-feedback intervention promoting four key components of the Mediterranean diet. Fifty-three (intervention group) and nineteen (control group) healthy females were recruited from the Universities of Glasgow and Glasgow Caledonian, Scotland, respectively. Participants in the intervention group received tailored dietary and psychosocial feedback and Internet nutrition education over a 6-month period, while participants in the control group were provided with minimal dietary feedback and general healthy-eating brochures. Internet education was provided via an innovative Mediterranean Eating Website. Dietary changes were assessed with 7 d estimated food diaries at baseline and 6 months, and data were analysed to calculate the Mediterranean Diet Score, a composite score based on the consumption of eight components of the traditional Mediterranean diet. The ‘intention-to-treat’ analyses showed that, at 6 months, participants in the intervention group had significantly increased their intake of vegetables, fruits and legumes, as well as the MUFA:saturated fatty acid ratio in their diet, and had significantly increased plasma HDL-cholesterol levels and a reduced ratio of total:HDL-cholesterol. Participants in the control group increased their intake of legumes but showed no other favourable significant changes compared with baseline. This Internet-based, tailored-feedback intervention promoting components of the Mediterranean diet holds promise in encouraging a greater consumption of plant foods, as well as increasing monounsaturated fat and decreasing saturated fat in the Scottish diet; it also shows that the Mediterranean diet can be adopted by healthy individuals in northern European countries.

scholarly journals Implementation and effectiveness of a multi-domain program for older adults at risk of cognitive impairment at neighborhood senior centres

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Pei Ern Mary Ng ◽  
Sean Olivia Nicholas ◽  
Shiou Liang Wee ◽  
Teng Yan Yau ◽  
Alvin Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
At Risk ◽  
Cognitive Impairment ◽  
Mobile Application ◽  
Intervention Group ◽  
Blood Parameters ◽  
Attrition Rate ◽  
Control Group

AbstractTo address the paucity of research investigating the implementation of multi-domain dementia prevention interventions, we implemented and evaluated a 24-week, bi-weekly multi-domain program for older adults at risk of cognitive impairment at neighborhood senior centres (SCs). It comprised dual-task exercises, cognitive training, and mobile application-based nutritional guidance. An RCT design informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework was adopted. Outcome measures include cognition, quality of life, blood parameters, and physical performance. Implementation was evaluated through questionnaires administered to participants, implementers, SC managers, attendance lists, and observations. The program reached almost 50% of eligible participants, had an attrition rate of 22%, and was adopted by 8.7% of the SCs approached. It was implemented as intended; only the nutritional component was re-designed due to participants’ unfamiliarity with the mobile application. While there were no between-group differences in cognition, quality of life, and blood parameters, quality of life reduced in the control group and physical function improved in the intervention group after 24 weeks. The program was well-received by participants and SCs. Our findings show that a multi-domain program for at-risk older adults has benefits and can be implemented through neighborhood SCs. Areas of improvement are discussed.Trial registration: ClinicalTrials.gov NCT04440969 retrospectively registered on 22 June 2020.

scholarly journals Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

2021 ◽  
Vol 18 (7) ◽  
pp. 3689
Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  
Keyword(s):  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stressful Events ◽  
Control Group ◽  
Subjective Well Being ◽  
Intention To Treat ◽  
School Year ◽  
Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

The Effectiveness of a Healthcare Application and Human Coaching Program in Primary Care Clinics: A Non-randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
HyoRim Ju ◽  
EunKyo Kang ◽  
YoungIn Kim ◽  
HyunYoung Ko ◽  
Belong Cho
Keyword(s):  
Primary Care ◽  
Weight Loss ◽  
Sleep Quality ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Primary Care Clinics ◽  
Healthcare Application

BACKGROUND As the global burden of chronic conditions increases, effective management for these are a concern. There is an increasing need for chronic condition management using mobile self-management healthcare applications. OBJECTIVE This study evaluated the effectiveness of a mobile self-management healthcare application combined with human coaching for primary care services in patients with chronic conditions. METHODS A total of 110 patients with hypertension, diabetes, dyslipidemia, and/or metabolic syndrome who visited one of 17 participating primary care clinics from September 2020 to November 2020 were included in this study. Data regarding changes in body weight, sleep conditions, quality of life, depression, anxiety, stress, body mass index, waist circumference, blood sugar levels, blood pressure, and blood lipids levels were recorded. The intervention group (N=65) used a mobile self-management healthcare application with human coaching for 12 weeks, and the control group (N=45) underwent conventional, self-managed health care. RESULTS Patients in the intervention group reported significantly more weight loss than those in the control group (P=.002). The weight loss was markedly greater after using application for nine weeks than using it for four weeks or five to eight weeks (P=.002). Patients in the intervention group reported better sleep quality (P=.04) and duration (P=.004) than those in the control group. CONCLUSIONS The combination of a mobile self-management healthcare application and human coaching in primary care clinics results in better management of chronic conditions. The observed weight loss was greater and sleep quality improved than conventional primary care for patients with at least one chronic condition.

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

scholarly journals A Digital Lifestyle Program in Outpatient Treatment of Type 2 Diabetes: A Randomized Controlled Study

2020 ◽  
pp. 193229682094228
Author(s):  
Eva Hilmarsdóttir ◽  
Árún K. Sigurðardóttir ◽  
Ragnheiður Harpa Arnardóttir
Keyword(s):  
Type 2 Diabetes ◽  
Outpatient Treatment ◽  
Healthy Lifestyle ◽  
Intervention Group ◽  
Well Being ◽  
Smartphone Application ◽  
Controlled Study ◽  
Control Group ◽  
Lifestyle Program

Background: Lifestyle is important in type 2 diabetes mellitus (T2DM). This study’s aim was to investigate whether a healthy-lifestyle-supporting smartphone application could affect treatment outcomes at an endocrinology outpatient clinic. Methods: Consecutively invited patients were randomly assigned to an intervention or control group after age and gender stratification. In addition to standard care, intervention group participants used a smartphone application to access a lifestyle program (SidekickHealth) through which they received personalized recommendations and education about healthy lifestyles. Tests at baseline and every other month for six months included body weight and blood tests for glycated hemoglobin (HbA1c) and blood lipids, as well as questionnaires about distress related to diabetes, health-related quality of life, depression, and anxiety. Statistics included comparisons both within and between groups. Results: A total of 37 patients (23 women) were included, whereof 30 finished, 15 in each group (19% dropout); the average age was 51.2 ± 10.6 (25-70) years. No significant differences emerged between groups, but within the intervention group, there was a significant decrease in HbA1c from 61 ± 21.4 to 52.7 ± 15.2 mmol/mol, in disease-specific distress from 19.5 ± 16.5 to 11.7 ± 13.4, and in anxiety symptoms from 5.4 ± 4.0 to 4.1 ± 3.8. No significant changes occurred within the control group. The application usage was most frequent during the first months and differed interpersonally. Conclusions: Our results indicate that the SidekickHealth digital lifestyle program could potentially enhance outpatient treatment in T2DM, in terms of both glycemic control and psychological well-being but larger confirmative studies are needed.

scholarly journals Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors

2015 ◽  
Vol 33 (28) ◽  
pp. 3169-3176 ◽  
Author(s):  
Cheryl L. Rock ◽  
Shirley W. Flatt ◽  
Tim E. Byers ◽  
Graham A. Colditz ◽  
Wendy Demark-Wahnefried ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Blood Pressure ◽  
Weight Loss ◽  
Breast Cancer Mortality ◽  
Intervention Group ◽  
Good Health ◽  
Control Group ◽  
Weight Loss Intervention ◽  
Behavioral Weight Loss ◽  
Behavioral Weight Loss Intervention

Purpose Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. Methods In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. Results At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P < .001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P < .001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. Conclusion A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.

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