Wearable Activity Tracking Device Use in an Adolescent Weight Management Clinic: A Randomized Controlled Pilot Trial

Background. The use of physical activity tracker devices has increased within the general population. However, there is limited medical literature studying the efficacy of such devices in adolescents with obesity. In this study, we explored the feasibility of using wearable activity tracking devices as an adjunct intervention on adolescents with obesity. Methods. Randomized controlled pilot trial evaluated the feasibility (attrition ≤50%) of an activity tracking intervention (ATI) and its effects on weight loss in adolescents with obesity enrolled in an adolescent weight management clinic (AWMC). Outcomes included feasibility (attrition rate) and absolute change in BMI. Differences between groups at 6, 12, and 18 weeks were examined. Results. Forty-eight participants were enrolled in the study. Eighteen subjects were randomly assigned to the ATI group and 30 to control. The average age was 14.5 years. Overall, the majority of participants were Hispanic (56%). Sexes were equally distributed. The average baseline BMI was 37.5 kg/m2. At the study conclusion, the overall attrition rate was 52.1%, 44.4% in the ATI group versus 56.6% in the control group, with a differential attrition of 12.2%. The ATI and control groups each showed an absolute decrease in BMI of −0.25 and −2.77, respectively, with no significant differences between the groups. Conclusion. The attrition rate in our study was >50%. Participation in the AWMC by the ATI and control groups resulted in maintenance of BMI and body weight for the study duration. However, the use of an activity tracking device was not associated with greater weight loss. This trial is registered with NCT03004378.

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Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211041104 ◽

2021 ◽

pp. 026921552110411

Author(s):

Hiromichi Takeda ◽

Katsuhiko Takatori

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Adherence ◽

Control Group ◽

Adult Day Care ◽

Control Groups ◽

Randomized Controlled ◽

And Control ◽

Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

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Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215512450521 ◽

2012 ◽

Vol 27 (2) ◽

pp. 133-141 ◽

Cited By ~ 27

Author(s):

Venkatesan Prem ◽

Ramesh Chandra Sahoo ◽

Prabha Adhikari

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Control Groups ◽

Quality Of Life Questionnaire ◽

Randomized Controlled ◽

Questionnaire Score ◽

And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

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Effects of vibration on chronic leg edema in chair-bound older adults: A randomized pilot trial

10.21203/rs.3.rs-54743/v1 ◽

2020 ◽

Author(s):

Sayumi Tsuchiya ◽

Aya Sato ◽

Terumi Ueda ◽

Misako Dai ◽

Mayumi Okuwa ◽

...

Keyword(s):

Pilot Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Interquartile Range ◽

Control Group ◽

Control Groups ◽

Post Intervention ◽

Leg Edema ◽

Clinical Trials Registry ◽

And Control

Abstract BackgroundElderly individuals can easily develop leg edema that can become chronic, which may result in various problems. Therefore, appropriate care for the edema should be provided. In some cases, chronic leg edema among elderly individuals cannot be controlled by the standard care such as leg elevation or compression. A previous study reported that vibration benefited upper limb lymphedema; however, its effects on chronic leg edema are not yet clarified. Therefore, this study aimed to clarify the effects of vibration for reducing chronic leg edema among chair-bound elderly individuals.MethodsFor participant allocation, a computer-generated list of random numbers was used. Nursing home residents aged ≥65 years with chronic leg edema who spent more time sitting than standing or lying during the day were randomly assigned to the intervention (n = 7) or control group (n = 7). The intervention group underwent vibration therapy three times a day for 2 weeks at 47 Hz and 1.78 m/s2 frequency and horizontal vibration acceleration, respectively. The pitting test was performed at 22 sites, and participants’ pitting scores were calculated based on the pitting depth. Pitting score changes at pre- and post-intervention were compared between the intervention and control groups. Both participants and investigators were not blinded to group assignment.ResultsThe median age of the intervention and control groups was 86 and 84 years, respectively. Participants’ characteristics and edema severity at baseline were not significantly different. The median total pitting score change in the intervention group was −0.4 (interquartile range: −5.3–1.8), which was significantly lower than that of the control group (2.0 [interquartile range: 1.0－5.3], P = 0.01). The intervention group was more likely to have controlled edema (64.3%) than the control group (21.4%) (χ2 (1) = 5.25, P = 0.02).ConclusionsThe intervention group was more likely to have controlled edema than the control group, suggesting that vibration could prevent the worsening of chronic leg edema in chair-bound elderly individuals.Trial registration: UMIN Clinical Trials Registry, UMIN000017716. Registered 1 July 2015, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020522

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A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.9793 ◽

2018 ◽

Author(s):

Marco Bardus ◽

Ghassan Hamadeh ◽

Bouchra Hayek ◽

Rawan Al Kherfan

Keyword(s):

Weight Loss ◽

Randomized Controlled Trial ◽

Weight Management ◽

Weight Control ◽

Mobile Apps ◽

Controlled Trial ◽

Overweight And Obesity ◽

Randomized Controlled ◽

Obesity And Overweight ◽

And Control

BACKGROUND Overweight and obesity have become major health problems globally with more than 1.9 billion overweight adults. In Lebanon, the prevalence of obesity and overweight is 65.4% combined. Risk factors of obesity and overweight are preventable and can be addressed by modifications in the environment and in an individual’s lifestyle. Mobile technologies are increasingly used in behavioral, self-directed weight management interventions, providing users with additional opportunities to attain weight control (weight loss, weight gain prevention, etc). Mobile apps may allow for the delivery of Just-in-Time Adaptive Interventions (JITAIs), which provide support through skill building, emotional support, and instrumental support, following the participants’ progress. A few commercially available apps offer JITAI features, but no studies have tested their efficacy. OBJECTIVE The primary objective of this study is to examine the feasibility of a self-directed weight loss intervention, targeting employees of an academic institution, using a virtual coaching app with JITAI features (Lark) and a self-help calorie-counting app (MyFitnessPal). The secondary objective is to estimate the effects of the intervention on main study outcomes. METHODS This study is a single-center, parallel, randomized controlled trial with 2 study arms (intervention and control). Participants will be randomly allocated in equal proportions to the intervention (Lark) and control groups (MyFitnessPal). To be eligible for this study, participants must be employed full- or part-time at the university or its medical center, able to read English, have a smartphone, and be interested in controlling their weight. Recruitment strategies entail email invitations, printed posters, and social media postings. We will assess quantitative rates of recruitment, adherence, and retention, self-reported app quality using the user version of the Mobile App Rating Scale. We will also assess changes in weight-related outcomes (absolute weight and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight). RESULTS WaznApp was funded in June 2017, and recruitment started in March 2018. CONCLUSIONS This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups. CLINICALTRIAL ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5) REGISTERED REPORT IDENTIFIER RR1-10.2196/9793

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The effect of prenatal counseling on breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding: A randomized controlled clinical trial

10.21203/rs.2.14118/v3 ◽

2020 ◽

Author(s):

fahimeh sehhatie shafaei ◽

mojgan mirghafourvand ◽

shiva havizari

Keyword(s):

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Prenatal Counseling ◽

Control Groups ◽

Randomized Controlled ◽

Breastfeeding Problems ◽

And Control

Abstract Background: Breastfeeding is one of the most important interfering factors in infants’ health. Monitoring mothers’ performance and providing them with the feedback helps to increase their self-efficacy, interest in learning, and level of performance. The present research evaluates the effect of prenatal counseling on the breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding.Methods: This randomized controlled clinical trial was conducted on 108 pregnant women with unsuccessful breastfeeding in Tabriz health centers during 2017-2018. The participants were randomly assigned to intervention and control groups. The intervention group had four prenatal counseling sessions and the controls only received routine care. Then, the mothers who gave birth to their children received a counseling session up to 4 months after the delivery. The Breastfeeding Self-Efficacy (BSES) questionnaire and the frequency of breast feeding problems checklist on the 15th day, and 2nd and 4th month were completed both by the intervention and control groups.Results: The mean (SD) of breastfeeding self-efficacy was 119.3 (10.5), 128.3 (8.3) and 133.8 (10.3) in the intervention group and 105.3 (16.1), 105.7 (19.7) and 109.4 (24.7) in the control group on the 15th day, 2nd and 4th month after the delivery, respectively. There was a significant difference in terms of breastfeeding self-efficacy between intervention and control group on the 15th day (p<0.001), and 2nd (p<0.001) and 4th (p<0.001) month after the delivery. The frequency of breastfeeding problems on the 15th (p=0.008), 2nd (p<0.001) and 4th (p<0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.Conclusion: The results indicated that prenatal counseling can increase mothers’ breastfeeding self-efficacy and solves most breastfeeding problems during postpartum period.Trial registration: IRCT20100109003027N19

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Shyness 3: Randomized Controlled Trial of Guided Versus Unguided Internet-Based CBT for Social Phobia

Australian & New Zealand Journal of Psychiatry ◽

10.1080/00048670802512107 ◽

2008 ◽

Vol 42 (12) ◽

pp. 1030-1040 ◽

Cited By ~ 137

Author(s):

Nickolai Titov ◽

Gavin Andrews ◽

Isabella Choi ◽

Genevieve Schwencke ◽

Alison Mahoney

Keyword(s):

Social Phobia ◽

Controlled Trial ◽

Control Group ◽

Treatment Programme ◽

Control Groups ◽

Randomized Controlled ◽

Online Discussion Forum ◽

Cognitive Behavioural ◽

The Social ◽

And Control

Objective: In two previous randomized controlled trials Titov et al. demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia. The present study (Shyness 3) explores whether participants are able to complete this programme independently. Method: A total of 98 individuals with social phobia were randomly assigned to a clinician-assisted computerized cognitive behavioural treatment (CaCCBT) group, a self-guided computerized CBT (CCBT) group, or to a waitlist control group. CaCCBT group participants completed the usual Shyness programme consisting of six online lessons, cognitive behavioural homework assignments, email contact with a therapist, and participation in an online discussion forum. CCBT group participants accessed the same resources except for therapist emails. An intention-to-treat model was used for data analyses. Results: A total of 77% of CaCCBT and 33% of CCBT group participants completed all lessons. Significant differences were found after treatment between CaCCBT and control groups (mean between-groups effect size (ES) for the social phobia measures = 1.04), and between the CaCCBT and CCBT groups (mean between-groups ES for the social phobia measures = 0.66). No significant differences were found after treatment between the CCBT and control groups (mean between-groups ES for the social phobia measures = 0.38). CCBT participants, however, who completed the six lessons made good progress (mean within-group ES for the social phobia measures = 0.62). Quantitative and qualitative data indicate that both the CaCCBT and CCBT procedures were acceptable to participants. Conclusions: The reliability of this Internet-based treatment programme for social phobia has been confirmed. The therapist-guided condition was superior to the self-guided condition, but a subgroup of participants still benefited considerably from the latter. These data confirm that self-guided education or treatment programmes for common anxiety disorders can result in significant improvements.

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A Hospital based Randomized Controlled Trial to Evaluate the Effectiveness of Kegel's Exercise on Postpartum Perineal Laxity

Journal of SAFOG with DVD ◽

10.5005/jp-journals-10006-1159 ◽

2011 ◽

Vol 3 (3) ◽

pp. 157-159

Author(s):

Sudha A Raddi ◽

TT Sheeba ◽

MB Ballad

Keyword(s):

Vaginal Delivery ◽

Postnatal Care ◽

Controlled Trial ◽

Control Group ◽

Control Groups ◽

Randomized Controlled ◽

Postnatal Mothers ◽

Perineal Muscle ◽

And Control ◽

Experimental Group

ABSTRACT Objectives The objectives of the study are to: (i) Assess the perineal muscle strength of postnatal mothers after vaginal delivery in the experimental and control groups before and after the intervention. (ii) Evaluate the effectiveness of Kegel's exercise on perineal laxity in the experimental group compared to control group. Methods This single blinded randomized controlled trial at a 1000 bedded tertiary care teaching hospital in India, enrolled 290 postnatal mothers between 20 and 40 years who had vaginal delivery with < 2 on modified Oxford grading scale as measured by per vaginal digital examination. The subjects were randomized into experimental and control groups. The experimental group received instructions to perform Kegel's exercises along with routine postnatal care while the control group received advice on routine postnatal care. Two follow-up assessments were done at 6 and 10 weeks. The primary outcome measure was increase in Oxford grading score. Results Major findings of the study were: The mean perineal muscle strength assessment scores noted before the intervention and during first and second postintervention assessments were 1.5 ± 0.52, 3.58 ± 0.51 and 4.28 ± 0.57 respectively for the experimental group and 1.56 ± 0.55, 2.41 ± 0.52 and 3 ± 0.51 respectively for the control group. Comparison of these scores between the groups by unpaired t-test yielded p-value of < 0.0001 suggesting high significant difference in favor of the experimental group. However, no additional benefit was observed after Kegel's exercise in the mothers who had episiotomy during vaginal delivery. Conclusion The Kegel's exercise is effective to reduce perineal laxity and hence should be included as a part of routine postnatal care.

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The effect of self-care counseling on depression and anxiety in women with Endometriosis: a randomized controlled trial.

10.21203/rs.3.rs-23064/v1 ◽

2020 ◽

Author(s):

Nooshin Farshi ◽

Shirin Hasanpour ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour

Keyword(s):

Quality Of Life ◽

Confidence Interval ◽

Self Care ◽

Mean Difference ◽

Control Group ◽

Depression And Anxiety ◽

Control Groups ◽

Randomized Controlled ◽

And Control

Abstract Background: Considering the prevalence of endometriosis and depression and anxiety caused by this disease and its effect on the body, mind and quality of life of patients, this study was performed to determine the effect of self-care counseling on depression and anxiety (primary outcome), and quality of life of women with endometriosis (secondary outcome). Method: This randomized controlled clinical trial was conducted on 76 women with endometriosis who were treated in Al-Zahra Teaching and Treatment Center of Tabriz between2017-2019. The patients were divided into intervention (counselling) and control groups using random blocking method. For the intervention group, self-care group counseling was held weekly for 7 sessions. The control group received routine care. The Socio-demographic Questionnaire, Beck Depression Inventory, Spline Berger Anxiety Inventory and SF36 Quality of Life Questionnaire were completed by the researcher through an interview before and four weeks after the intervention. Results: No statistically significant difference was found between the intervention and control groups in terms of socio-demographic characteristics (p>0.05). After intervention mean scores of state anxiety (mean difference: -0.12, 95% confidence interval: -9.6 to -14.4, p<0.001) and trait anxiety (mean difference: -10.9: 95% confidence interval: -9.1 to -12.7, p=0.001) were significantly lower than control group and mean score of depression in counseling group was less than control group but it was not significant (p=0/565). Mean score of quality of life in terms of physical health (mean difference= 17.2, 95% confidence interval: 13.8 to 20.5, p<0.001) and in terms of mental health mean difference = 12.0, 95% confidence interval: 9.0 to 14.9, p<0.001) were significantly upper in counselling group. Conclusion: Self-care counselling is effective on anxiety and quality of life of women with endometriosis. So in addition to other therapies, this method is recommended to improve the mental health of patients with this disease. Trial Registration: IRCT Registration Number: IRCT 20111219008459N13, registered 10 February 2019, https://irct.ir/user/trial/35915

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Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups

10.31219/osf.io/u7ewz ◽

2021 ◽

Author(s):

David Scheim ◽

Jennifer A. Hibberd ◽

Juan Chamie-Quintero

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Controlled Trial ◽

Control Group ◽

High Dose ◽

Control Groups ◽

Over The Counter ◽

Randomized Controlled ◽

Widespread Availability ◽

And Control

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

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Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Web-based Lifestyle Coaching Program in Denmark: Randomized Controlled Trial (Preprint)

10.2196/preprints.27240 ◽

2021 ◽

Author(s):

Jeanette Reffstrup Christensen ◽

Camilla Sortsø ◽

Jørgen T Lauridsen ◽

Pernille R Jakobsen ◽

Ditte H Laursen ◽

...

Keyword(s):

Type 2 Diabetes ◽

Weight Loss ◽

Body Composition ◽

Body Weight ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Number Of Patients ◽

And Control

BACKGROUND Lifestyle interventions can delay and reverse the onset of type 2 diabetes (T2D) and decrease morbidity and mortality. Studies suggest that digital coaching based on real-time monitoring can lead to clinically relevant weight loss, as well as decreased or normalized hemoglobin A1c (HbA1c) for a significant number of patients. OBJECTIVE To assess whether an eHealth lifestyle coaching program (LIVA 2.0) for patients with T2D who are motivated for lifestyle changes leads to significant weight loss and decreased HbA1c, compared to usual care. METHODS In a randomized controlled single-blinded trial, 170 patients with T2D were enrolled from March 2018 to March 2019 and randomized to the intervention (100) and control (70) groups. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The intervention comprised an initial face-to-face motivational interview followed by digital coaching. The same healthcare professional coach provided synchronous and asynchronous multimodal feedback and used digital behavioral change techniques enabled by an app providing live monitoring of lifestyle behaviors. Primary outcome was body weight. Secondary outcomes were changes in HbA1c, body composition, lipids, and quality of life at 6 months. RESULTS At 6 months, 75 patients (75%) in the intervention group and 53 patients (76%) in the control group remained in the study. Mean body weight loss was 4.2 kg (95% CI, 5.5- 3.0) in the intervention group vs 1.5 kg (95% CI, 2.57- 0.48) in the control group (P = .005). In the intervention group, 36 (52%) patients lost > 3% body weight, compared to 12 (32%) patients in the control group. Mean HbA1c was lower in both groups at 6 months, with reductions of 8.2% (95% CI, 11.01 to 5.29) and 5.5% (95% CI, 8.75 to 2.76) for the intervention and control groups, respectively (P = .203). In the intervention group, 24 (32%) had an HbA1c <6.5% at 6 months, compared to 8 (15%) in the control group (P = .03). CONCLUSIONS Reduction in body weight and remission rate for HbA1c, as well as improved body composition can be enhanced by using digital lifestyle coaching for patients with T2D. CLINICALTRIAL Trial Registration: Clinicaltrials.gov NCT03788915 https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR2-10.2196/19172 INTERNATIONAL REGISTERED REPORT RR2-10.2196/19172

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