Long-term effects of the use of a step count-specific smartphone application on physical activity and weight loss: a randomized clinical trial (Preprint)

BACKGROUND Some studies on weight loss promotion using smartphone applications (smartphone app) including mobile applications have shown a weight loss effect, but not an increase in physical activity, and they have not been rigorously examined for longer periods. OBJECTIVE To assess whether the use of a smartphone app will increase physical activity and reduce body weight. METHODS In this parallel randomized clinical trial, participants recruited between April 2018 and June 2019 were randomized in equal proportions to a smartphone app group (n=55) or control group (n=54). The intention-to-treat approach was used to analyze the data from December 2019 through November 2021.　Before the intervention, an hour-long lecture on weight loss instruction and increasing physical activity was conducted once for both groups. Participants in both groups were instructed to weigh themselves immediately after waking up at least once daily from the start of the intervention. Monthly e-mails were sent advising the participants on how to lose weight and increase physical activity in order to maintain or increase motivation in both groups. Participants in the smartphone app group were instructed to launch the app at least once a day to check their step count and rank. The primary outcome was daily accelerometer-measured physical activity (step count) and secondary outcomes was body weight. RESULTS The 109 participants had a mean (standard deviation) age of 47 (8) years. At baseline, the mean (standard deviation) daily total steps were 7259 (3256) for the smartphone app and 8243 (2815) for control groups, respectively. After the 32-week intervention period, the step count per wear time was significantly higher in the smartphone app group than in the control group [average difference (95%CI): 65 (30 to 101) vs. -9 (-56 to 39), p=0.042]. The weight loss was -2.2 kg (-3.1%) in the smartphone app group and -2.2 kg (-3.1%) in the control group, with no significant difference between the groups. During the intervention period, the step count per wear time on Saturdays [615 (545 to 684) vs. 554 (483 to 624), p=0.006] and Sundays [623 (553 to 694) vs. 556 (485 to 627), p=0.004] was significantly higher in the smartphone app group than in the control group. CONCLUSIONS In this trial, the smartphone app group showed increased physical activity, especially on weekends. However, this increased physical activity did not lead to weight loss. CLINICALTRIAL UMIN000033397 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000037956&type=summary&language=J

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Evaluation of the telephone intervention in the promotion of diabetes self-care: a randomized clinical trial

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.0632.2719 ◽

2016 ◽

Vol 24 (0) ◽

Author(s):

Bárbara Sgarbi Morgan Fernandes ◽

Ilka Afonso Reis ◽

Heloisa de Carvalho Torres

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Self Care ◽

The Self ◽

Control Group ◽

Telephone Intervention ◽

Belo Horizonte ◽

Clinical Trials Registry ◽

Experimental Group

ABSTRACT Objective: to evaluate the effectiveness of the telephone intervention for promoting self-care related to physical activity and following a diet plan in users with diabetes, compared to conventional monitoring of users over a six-month period. Method: this was a randomized clinical trial, which included 210 users with diabetes, linked to eight Primary Health Units of Belo Horizonte, Minas Gerais. The experimental group (104 members) received six telephone interventions over the six-month monitoring; the control group (106 members) received conventional monitoring. To evaluate the self-care practices related to physical activity and following a healthy eating plan, in both groups, the self-care questionnaire was applied before the intervention and at three and six months after its start. Results: the mean effect of self-care scores in the experimental group was 1.03 to 1.78 higher than the control group, with progressive and significant improvement (p<0.001). Conclusion: the results indicate that the telephone intervention had a beneficial effect on diabetes self-care. The primary identifier of the clinical trials registry was: RBR-8wx7qb.

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Beneficial Effects of Adenosine Triphosphate on Nutritional Status in Advanced Lung Cancer Patients: A Randomized Clinical Trial

Journal of Clinical Oncology ◽

10.1200/jco.2002.20.2.371 ◽

2002 ◽

Vol 20 (2) ◽

pp. 371-378 ◽

Cited By ~ 15

Author(s):

Hendrik J. Agteresch ◽

Trinet Rietveld ◽

Leon G.M. Kerkhofs ◽

J. Willem O. van den Berg ◽

J. H. Paul Wilson ◽

...

Keyword(s):

Lung Cancer ◽

Clinical Trial ◽

Body Composition ◽

Body Weight ◽

Energy Expenditure ◽

Randomized Clinical Trial ◽

Energy Intake ◽

Advanced Lung Cancer ◽

Control Group ◽

Muscle Area

PURPOSE: In a randomized clinical trial in patients with advanced non–small-cell lung cancer (NSCLC), infusion with adenosine 5′-triphosphate (ATP) inhibited loss of body weight and quality of life. In the present article, the effects of ATP on body composition, energy intake, and energy expenditure as secondary outcome measures in the same patients are reported. PATIENTS AND METHODS: Patients with NSCLC, stage IIIB or IV, were randomized to receive either 10 intravenous, 30-hour ATP infusions every 2 to 4 weeks or no ATP. Fat mass (FM), fat-free mass (FFM), and arm muscle area were assessed at 4-week intervals for 28 weeks. Food intake, body cell mass (BCM), and resting energy expenditure (REE) were assessed at 8-week intervals for 16 weeks. Between-group differences were tested for statistical significance by repeated-measures analysis of covariance. RESULTS: Fifty-eight patients were randomized (28 ATP, 30 control). No change in body composition over the 28-week follow-up period was found in the ATP group, whereas, per 4 weeks, the control group lost 0.6 kg of FM (P = .004), 0.5 kg of FFM (P = .02), 1.8% of arm muscle area (P = .02), and 0.6% of BCM/kg body weight (P = .054) and decreased 568 KJ/d in energy intake (P = .0001). Appetite also remained stable in the ATP group but decreased significantly in the control group (P = .0004). No significant differences in REE between the ATP and control groups were observed. CONCLUSION: The inhibition of weight loss by ATP infusions in patients with advanced NSCLC is attributed to counteracting the loss of both metabolically active and inactive tissues. These effects are partly ascribed to maintenance of energy intake.

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Randomized Clinical Trial of Balance-Based Torso Weighting for Improving Upright Mobility in People with Multiple Sclerosis

Neurorehabilitation and Neural Repair ◽

10.1177/1545968309336146 ◽

2009 ◽

Vol 23 (8) ◽

pp. 784-791 ◽

Cited By ~ 33

Author(s):

Gail L. Widener ◽

Diane D. Allen ◽

Cynthia Gibson-Horn

Keyword(s):

Multiple Sclerosis ◽

Clinical Trial ◽

Body Weight ◽

Randomized Clinical Trial ◽

Phase 1 ◽

Gait Velocity ◽

Control Group ◽

Phase 2 ◽

Timed Up And Go ◽

Standard Weight

Background. Torso weighting has sometimes been effective for improving upright mobility in people with multiple sclerosis, but parameters for weighting have been inconsistent. Objective. To determine whether balance-based torso weighting (BBTW) has immediate effects on upright mobility in people with multiple sclerosis. Methods. This was a 2-phase randomized clinical trial. In phase 1, 36 participants were randomly assigned to experimental and control groups. In phase 2, the control group was subsequently randomized into 2 groups with alternate weight-placement. Tests of upright mobility included: timed up and go (TUG), sharpened Romberg, 360-degree turns, 25-foot walk, and computerized platform posturography. Participants were tested at baseline and again with weights placed according to group membership. In both phases, a physical therapist assessed balance for the BBTW group and then placed weights to decrease balance loss. In phase 1, the control group had no weights placed. In phase 2, the alternate treatment group received standard weight placement of 1.5% body weight. Results. People with BBTW showed a significant improvement in the 25-foot walk ( P = .01) over those with no weight, and the TUG ( P = .01) over those with standard weight placement. BBTW participants received an average of 0.5 kg, less than 1.5% of any participant’s body weight. Conclusion. BBTW can have immediate advantages over a nonweighted condition for gait velocity and over a standardized weighted condition for a functional activity in people with multiple sclerosis (MS) who are ambulatory but have balance and mobility abnormalities.

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Objective physical activity and weight loss in adults: The step-up randomized clinical trial

Obesity ◽

10.1002/oby.20830 ◽

2014 ◽

Vol 22 (11) ◽

pp. 2284-2292 ◽

Cited By ~ 26

Author(s):

John M. Jakicic ◽

Deborah F. Tate ◽

Wei Lang ◽

Kelliann K. Davis ◽

Kristen Polzien ◽

...

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Weight Loss ◽

Randomized Clinical Trial

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Evaluating the Effect of Positive Touch on Moods of Mothers of Premature Infants Hospitalized in NICU: A Randomized Clinical Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.109251 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Seyedeh Fahimeh Alijanzadeh Zaferani ◽

Ali Zabihi ◽

Seyedeh Roghayeh Jafarian Amiri ◽

Zahra Akbarian ◽

Karim' Allah Hajian

Keyword(s):

Clinical Trial ◽

Standard Deviation ◽

Randomized Clinical Trial ◽

Premature Infants ◽

Neonatal Intensive Care ◽

Mood States ◽

Control Group ◽

Northern Iran ◽

The Mean ◽

Positive Touch

Background: The birth and hospitalization of a premature infant in the neonatal intensive care unit (NICU) can cause mood swings in mothers. Improving these mothers’ moods and reducing their stress is a care priority, which can be achieved by applying some innovative = strategies like using positive touch. Objectives: The purpose of the present study was to investigate the effect of positive touch on mood states of mothers of premature infants hospitalized in the NICU. Methods: The present randomized clinical trial was conducted on 80 mothers whose premature infants were hospitalized in the NICU of two hospitals in northern Iran in 2018. The participants were divided into two equal groups (n = 40) of experimental and control. All participants received a Profile of Mood States (POMS) questionnaire both at the time of admission and discharge. The experimental group received positive touch from the beginning of admission to the NICU until the time of discharge, while the control group only received the routine care. Results: The mean and standard deviation of mothers’ mood scores before the intervention (74.35 ± 36.27) were significantly higher compared to after the intervention (48.63 ± 16.02) (P = 0.001). Moreover, the mean and standard deviation for the sub-components were as follows: (1) tension before intervention (13.6 ± 7.49) vs. after intervention (7.45 ± 4.107) (P < 0.001); (2) depression before intervention (15.73 ± 13.11) vs. after intervention (7.5 ± 8.85) (P < 0.001); (3) fatigue before intervention (7.5 ± 6.47) vs. after intervention (3.95 ± 2.88) (P < 0.001); (4) confusion before intervention (9.63 ± 4.65) vs. after intervention (6.73 ± 2.42) (P < 0.001); (5) anger before intervention (12.97 ± 9.58) vs. after intervention (6.07 ± 4.42) (P < 0.001); and (6) vigor before intervention (14.93 ± 4.59) vs. after intervention (16.93 ± 3.21) (P = 0.001). As the figures show, there were significant differences in all of the sub-components before and after the intervention. Conclusions: It is recommended that mothers be given more opportunities in the NICU to employ positive touch and establish a closer interaction with their infants.

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Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study) (Preprint)

10.2196/preprints.21771 ◽

2020 ◽

Author(s):

Cristina Lugones-Sanchez ◽

Maria Antonia Sanchez-Calavera ◽

Irene Repiso-Gento ◽

Esther G Adalia ◽

J Ignacio Ramirez-Manent ◽

...

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Weight Loss ◽

Body Composition ◽

Body Fat ◽

Vigorous Physical Activity ◽

Activity Level ◽

Smartphone App ◽

Mhealth Intervention ◽

Randomized Controlled

BACKGROUND Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. OBJECTIVE This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. METHODS A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. RESULTS The mHealth intervention produced a greater loss of body weight (–1.97 kg, 95% CI –2.39 to –1.54) relative to standard counselling at 3 months (–1.13 kg, 95% CI –1.56 to –0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; –1.84 kg, 95% CI –2.48 to –1.20), percentage of body fat (PBF; –1.22%, 95% CI –1.82% to 0.62%), and BMI (–0.77 kg/m2, 95% CI –0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of –1.18 kg (95% CI –2.30 to –0.06) and BMI of –0.47 kg/m2 (95% CI –0.80 to –0.13), whereas the obese group only experienced a change in BMI of –0.53 kg/m2 (95% CI –0.86 to –0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of –1.03 kg (95% CI –1.74 to –0.33), PBF of –0.76% (95% CI –1.32% to –0.20%), and BMI of –0.5 kg/m2 (95% CI –0.83 to –0.19). CONCLUSIONS The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect. CLINICALTRIAL Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT RR2-10.1097/MD.0000000000009633

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Hypocaloric diet with lower meal frequency did not affect weight loss, body composition and insulin responsiveness, but improved lipid profile: a randomized clinical trial

Food & Function ◽

10.1039/d1fo00484k ◽

2021 ◽

Author(s):

Érika Duarte Grangeiro ◽

Mariana Silva Trigueiro ◽

Leysimar de Oliveira Siais ◽

Hilana Moreira Paiva ◽

Mauro Sola-Penna ◽

...

Keyword(s):

Clinical Trial ◽

Weight Loss ◽

Body Composition ◽

Body Weight ◽

Lipid Profile ◽

Randomized Clinical Trial ◽

Body Weight Loss ◽

Hypocaloric Diet ◽

Meal Frequency ◽

Insulin Responsiveness

Dietary approaches are essential to control obesity, but the effectiveness of changes in meal frequency (MF) as a strategy for body weight loss or maintenance remain unclear.

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Abstract P131: Effect of a Social Incentive-based Gamification Intervention Using Wearable Devices and Smartphones on Physical Activity: The BE FIT Randomized Clinical Trial

Circulation ◽

10.1161/circ.135.suppl_1.p131 ◽

2017 ◽

Vol 135 (suppl_1) ◽

Author(s):

Mitesh S Patel ◽

Emelia J Benjamin ◽

Kevin G Volpp ◽

Caroline S Fox ◽

Dylan S Small ◽

...

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Health Behaviors ◽

Behavioral Economics ◽

Randomized Clinical Trial ◽

Family Members ◽

Intervention Period ◽

Social Incentives ◽

The Mean

Background: Social networks can influence individual health behaviors, but interventions that leverage social incentives within these networks to change health behaviors have not been well examined. The objective of this study was to test the effectiveness of a social incentive-based gamification intervention to increase physical activity in the community. Methods: The Behavioral Economics Framingham Incentive Trial (BE FIT) was a randomized clinical trial that recruited 206 adults comprising 97 groups of two or three family members in the Framingham Heart Study and occurred between December 2015 and August 2016. Participants used a wearable device or smartphone application to establish a baseline step count and selected a step goal increase for a 12-week primary intervention period and a 12-week follow-up period. Participants in both the control and intervention arms received daily feedback on their performance for 24 weeks. During the first 12 weeks, participants in the intervention arm played a game (including points, levels, and lifelines) with their family members that was designed using insights from behavioral economics to enhance social incentives such as peer support, accountability, and collaboration. The primary outcome was the mean proportion of participant-days the step goal was achieved during the primary intervention period. Secondary outcomes included the mean proportion of participant-days the step goal was achieved during the follow-up period and mean daily steps during the intervention and follow-up periods. Results: Participants in the intervention arm achieved step goals on a greater proportion of participant-days and had greater mean daily steps than the control arm during the intervention and follow-up periods (TABLE). Conclusions: Among groups of family members in a community, a social incentive-based gamification intervention was effective at increasing physical activity during the 12-week intervention period and effects were sustained during the 12-week follow-up period.

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Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

10.2196/preprints.13747 ◽

2019 ◽

Cited By ~ 2

Author(s):

Alberto Hernández-Reyes ◽

Fernando Cámara-Martos ◽

Guillermo Molina Recio ◽

Rafael Molina-Luque ◽

Manuel Romero-Saldaña ◽

...

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Weight Loss ◽

Body Composition ◽

Controlled Trial ◽

Intervention Group ◽

The Body ◽

Control Group ◽

Obese Women ◽

Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; P>.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

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Use of Mobile Phone App Interventions to Promote Weight Loss: Meta-Analysis (Preprint)

10.2196/preprints.17039 ◽

2019 ◽

Author(s):

Md.Mohaimenul Islam ◽

Tahmina Nasrin Poly ◽

Bruno Andres Walther ◽

Yu-Chuan (Jack) Li

Keyword(s):

Physical Activity ◽

Weight Loss ◽

Body Weight ◽

Mobile Phone ◽

Controlled Trial ◽

Meta Analysis ◽

Mobile App ◽

Control Group ◽

Promote Weight Loss ◽

The Impact

BACKGROUND Obesity and lack of physical activity are major health risk factors for many life-threatening diseases, such as cardiovascular diseases, type 2 diabetes, and cancer. The use of mobile app interventions to promote weight loss and boost physical activity among children and adults is fascinating owing to the demand for cutting-edge and more efficient interventions. Previously published studies have examined different types of technology-based interventions and their impact on weight loss and increase in physical activity, but evidence regarding the impact of only a mobile phone app on weight loss and increase in physical activity is still lacking. OBJECTIVE The main objective of this study was to assess the efficacy of a mobile phone app intervention for reducing body weight and increasing physical activity among children and adults. METHODS PubMed, Google Scholar, Scopus, EMBASE, and the Web of Science electronic databases were searched for studies published between January 1, 2000, and April 30, 2019, without language restrictions. Two experts independently screened all the titles and abstracts to find the most appropriate studies. To be included, studies had to be either a randomized controlled trial or a case-control study that assessed a mobile phone app intervention with body weight loss and physical activity outcomes. The Cochrane Collaboration Risk of Bias tool was used to examine the risk of publication bias. RESULTS A total of 12 studies involving a mobile phone app intervention were included in this meta-analysis. Compared with the control group, the use of a mobile phone app was associated with significant changes in body weight (−1.07 kg, 95% CI −1.92 to −0.21, P=.01) and body mass index (−0.45 kg/m2, 95% CI −0.78 to −0.12, P=.008). Moreover, a nonsignificant increase in physical activity was observed (0.17, 95% CI −2.21 to 2.55, P=.88). CONCLUSIONS The findings of this study demonstrate the promising and emerging efficacy of using mobile phone app interventions for weight loss. Future studies are needed to explore the long-term efficacy of mobile app interventions in larger samples.

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