Effectiveness of a Worksite Intervention for Male Construction Workers on Dietary and Physical Activity Behaviors, Body Mass Index, and Health Outcomes: Results of a Randomized Controlled Trial

Purpose: To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior, health indicators, and prevention and reduction of overweight among construction workers. Design: Randomized controlled trial. Setting: Various blue-collar departments of a large construction company in the Netherlands. Participants: Blue-collar workers randomized to an intervention (n = 162) or a control group (n = 152). Intervention: The intervention group received individual coaching sessions, tailored information, and materials to improve lifestyle behavior during a 6-month period, and the control group received usual care. Measures: Body weight, body mass index (BMI), waist circumference, physical activity (PA) levels, dietary behavior, blood pressure, and blood cholesterol were assessed. Analysis: Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels. Results: After 6 months, a statistically significant intervention effect was found on body weight ( B = −1.06, P = .010), BMI ( B = −0.32, P = .010), and waist circumference ( B = −1.38, P = .032). At 6 months, the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06, P = .032), and for sugar-sweetened beverages, an intervention effect was found at 6 months as well ( B = −2.82, P = .003). At 12 months, for weight-related outcomes, these differences were slightly smaller and no longer statistically significant. The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes. Conclusion: Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls, as well as effects on weight-related outcomes at 6 months. Long-term effects were still promising but not statistically significant.

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

10.2196/preprints.19624 ◽

2020 ◽

Author(s):

Stephanie Erika Bonn ◽

Mari Hult ◽

Kristina Spetz ◽

Marie Löf ◽

Ellen Andersson ◽

...

Keyword(s):

Physical Activity ◽

Bariatric Surgery ◽

Controlled Trial ◽

Intervention Group ◽

Study Participant ◽

Lifestyle Factors ◽

Lifestyle Changes ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

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Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

10.2196/preprints.33852 ◽

2021 ◽

Author(s):

Masahiro Kondo ◽

Teru Okitsu ◽

Kayo Waki ◽

Toshimasa Yamauchi ◽

Masaomi Nangaku ◽

...

Keyword(s):

Abdominal Obesity ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Metabolic Parameters ◽

Control Group ◽

Physical Parameters ◽

Lifestyle Behavior ◽

Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

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Paternal Lifestyle-Related Parenting Practices Mediate Changes in Children’s Dietary and Physical Activity Behaviors: Findings From the Healthy Dads, Healthy Kids Community Randomized Controlled Trial

Journal of Physical Activity and Health ◽

10.1123/jpah.2014-0367 ◽

2015 ◽

Vol 12 (9) ◽

pp. 1327-1335 ◽

Cited By ~ 23

Author(s):

Adam B. Lloyd ◽

David R. Lubans ◽

Ronald C. Plotnikoff ◽

Philip J. Morgan

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Parenting Practices ◽

Controlled Trial ◽

Control Group ◽

Intervention Effect ◽

Wait List Control ◽

Randomized Controlled ◽

Logistic Support ◽

Children’S Physical Activity

Background:This study examined potential parenting-related mediators of children’s physical activity and dietary behavior change in the Healthy Dads, Healthy Kids (HDHK) community program.Methods:A randomized controlled trial was conducted with 45 overweight/obese (mean [SD] age = 39.8 [5.4] years; BMI = 32.4 [3.8]) fathers and their children (n = 77; 58% boys; mean [SD] age = 7.7 [2.5] years). Families were randomized to either the HDHK program or wait-list control group. The program involved 7 sessions. Fathers and their children were assessed at baseline and at 14 weeks for physical activity (pedometery) and core food intake (Questionnaire). Fathers’ lifestyle-related parenting practices included; self-efficacy, beliefs, modeling, logistic support, rules, cophysical activity, shared mealtime frequency and intentions.Results:Significant intervention effects were found for cophysical activity and modeling physical activity. Cophysical activity mediated children’s physical activity in the intervention (‘mediated effect,’ AB = 653, 95% CI = 4–2050) and was responsible for 59.5% of the intervention effect. Fathers’ beliefs mediated children’s percent energy from core foods (AB = 1.51, 95% CI = 0.05–5.55) and accounted for 72.9% of the intervention effect.Conclusions:Participation in the HDHK program positively impacted on fathers’ cophysical activity with their child and beliefs about healthy eating which mediated changes in children’s diet and physical activity behaviors.

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Abstract P200: Effects Of A 2-year Randomized Controlled Trial Physical Activity Intervention On Accelerometer-measured Sleep Characteristics Among Older Adults In Senior Center Communities

Circulation ◽

10.1161/circ.143.suppl_1.p200 ◽

2021 ◽

Vol 143 (Suppl_1) ◽

Author(s):

Kelsie M Full ◽

Katie Crist ◽

Marta Jankowska ◽

Pamela L Lutsey ◽

Loki Natarajan

Keyword(s):

Physical Activity ◽

Older Adults ◽

Sleep Duration ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Sleep Efficiency ◽

Control Group ◽

Senior Center ◽

Intervention Effect

Background: Targeting daily increases in physical activity (PA) is a common lifestyle strategy for cardiovascular disease (CVD) risk reduction. While less targeted in lifestyle interventions, poor sleep is also consistently linked to CVD. Emerging evidence connects changes in daily PA to beneficial changes in sleep; however, little is known about the impact of community-based PA interventions on habitual sleep among older adults. We leveraged accelerometer data from the Peer Empowerment Program for Physical Activity in Low Income & Minority Seniors (PEP4PA) randomized controlled trial to examine the effect of a PA intervention on accelerometer-measured sleep characteristics among older adults in low income and diverse senior center communities. Methods: PEP4PA participants (N=476; mean age=71.0 ± 9 years, 75% female, 60% low income, 36% non-white) were recruited from senior centers and randomized to a healthy control condition(n=209) or a peer-lead walking intervention (N=267). The peer-led PA intervention included self-monitoring techniques, health coach counseling, group walks, and community advocacy to improve walking conditions. Participants wore Actigraph GT3X+ accelerometers on the wrist at baseline, 6, 12, and 24 months. Data were processed for sleep characteristics including weekly average sleep duration and sleep efficiency. Mixed effects regression models provided estimates of the intervention effect on sleep characteristics at each time point. Models were adjusted for age, sex, and race. Three way interaction terms (time*treatment*sleep duration status) were used to assess differential intervention effects by short (<7) and long (>8 hours) sleep duration status at baseline. Results: At baseline, the average sleep duration of participants was 7 hours (SD: 1.07 hours) and the average sleep efficiency was 87.0% (SD: 6.2%). Compared to participants in the control group, participants in the intervention group had shorter sleep durations (7.1 hours vs 7.0 hours; p value: 0.08) and poorer sleep efficiency 86.0% vs 88.2%; p<0.001) at baseline. At 12 or 24-months, there was no intervention effect on participants’ average sleep duration or efficiency. Although not significant, at 6 months, long sleepers in the intervention group experienced an average 6-minute reduction in sleep duration (-B: 6.25, p=0.45) compared to those in the control group. Conclusions: Over the 2-year period, the PA intervention did not appear to have an impact on participants’ average sleep duration or quality. More investigation is needed into the temporal and daily relations of PA and sleep among older adults in interventions to understand if increases in daily PA are associated with better sleep characteristics at night.

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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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Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial

Public Health Nutrition ◽

10.1017/s1368980018000319 ◽

2018 ◽

Vol 21 (8) ◽

pp. 1426-1434 ◽

Cited By ~ 7

Author(s):

Rebecca L Franckle ◽

Douglas E Levy ◽

Lorena Macias-Navarro ◽

Eric B Rimm ◽

Anne N Thorndike

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Financial Incentives ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Traffic Light ◽

Sugar Sweetened Beverages ◽

Randomized Controlled ◽

Sweetened Beverages

AbstractObjectiveThe objective of the present study was to test the effectiveness of financial incentives and traffic-light labels to reduce purchases of sugar-sweetened beverages in a community supermarket.DesignIn this randomized controlled trial, after a 2-month baseline period (February–March 2014), in-store traffic-light labels were posted to indicate healthy (green), less healthy (yellow) or unhealthy (red) beverages. During the subsequent five months (April–August 2014), participants in the intervention arm were eligible to earn a $US 25 in-store gift card each month they refrained from purchasing red-labelled beverages.SettingUrban supermarket in Chelsea, MA, USA, a low-income Latino community.SubjectsParticipants were customers of this supermarket who had at least one child living at home. A total of 148 customers (n 77 in the intervention group and n 71 in the control group) were included in the final analyses.ResultsOutcomes were monthly in-store purchases tracked using a store loyalty card and self-reported consumption of red-labelled beverages. Compared with control participants, the proportion of intervention participants who purchased any red-labelled beverages decreased by 9 % more per month (P=0·002). More intervention than control participants reduced their consumption of red-labelled beverages (−23 % v. −2 % for consuming ≥1 red beverage/week, P=0·01).ConclusionsOverall, financial incentives paired with in-store traffic-light labels modestly reduced purchase and consumption of sugar-sweetened beverages by customers of a community supermarket.

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INCREASING PHYSICAL ACTIVITY POST-KIDNEY TRANSPLANT: A PILOT RANDOMIZED CONTROLLED TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.1919 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S521-S521

Author(s):

Tara O’Brien ◽

Cynthia Russell ◽

Donna Hathaway

Keyword(s):

Physical Activity ◽

Kidney Transplant ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Randomized Controlled ◽

Activity Trackers ◽

Pilot Randomized Controlled Trial

Abstract Older kidney transplant recipients are at risk for graft failure and death due to lack of physical activity. Physical activity after transplant is the most modifiable non-pharmacological factor for improving physical function. One personal system intervention called, SystemCHANGE™ in combination with activity trackers, holds promise for increasing physical activity among this population. The purpose of this pilot randomized controlled trial was to evaluate the efficacy of SystemCHANGE™ on increasing average daily steps in older (age 60 and over) kidney transplant recipients from baseline to 6 months. The intervention group met monthly to implement a successful personal system solution based on their daily routines and step-data collected from the activity tracker. The control group received monthly educational information on healthy living with a transplant. Participants were randomized 1:1 to the intervention or control group. The sample consisted of 31 participants (n = 15 intervention, and n = 16 control). No significant differences were found at baseline among the groups for demographics, self-efficacy and health outcomes (blood pressure, weight, waist circumference, 6 minute Walk Test). However, the intervention group had greater increase in the average daily steps from baseline to 6 months (mean ± SD: 1511 ± 2320) as compared to the control group (181 ± 2419). The between-group difference was of medium effect size (d = .56).The data suggests SystemCHANGE™ in combination with activity trackers may be feasible for older kidney transplant recipients to enhance daily steps.

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Effectiveness of the Healthy Start-Départ Santé approach on physical activity, healthy eating and fundamental movement skills of preschoolers attending childcare centres: A randomized controlled trial

10.21203/rs.2.12703/v3 ◽

2019 ◽

Author(s):

Anne Leis ◽

Stéphanie Ward ◽

Hassan Vatanparast ◽

Louise Humbert ◽

Amanda Froehlich Chow ◽

...

Keyword(s):

Physical Activity ◽

Food Intake ◽

Healthy Eating ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Usual Practice ◽

Movement Skills ◽

Randomized Controlled ◽

Fundamental Movement Skills

Abstract Background: Since young children spend approximately 30 hours per week in early childcare centres (ECC), this setting is ideal to foster healthy behaviors. This study aimed to asses the effectiveness of the Healthy Start-Départ Santé (HSDS) randomized controlled trial in increasing physical activity (PA) levels and improving healthy eating and fundamental movement skills in preschoolers attending ECC. Methods: Sixty-one ECC were randomly selected and allocated to either the usual practice (n=30; n=433 children) or intervention group (n=31; n=464 children). The HSDS intervention group was provided a 3-hour on-site training for childcare educators which aimed to increase their knowledge and self-efficacy in promoting healthy eating, PA and development of fundamental movement skills in preschoolers. PA was measured during childcare hours for five consecutive days using the Actical accelerometer. Preschoolers’ fundamental movement skills were assessed using the standard TGMD-II protocol and POMP scores. Food intake was evaluated using digital photography-assisted weighted plate waste at lunch, over two consecutive days. All data were collected prior to the HSDS intervention and again 9 months later. Mixed-effect models were used to analyse the effectiveness of the HSDS intervention on all outcome measures. Results: Total number of children who provided valid data at baseline and endpoint for PA, food intake and fundamental movement skills were 259, 670 and 492, respectively. Children in the HSDS intervention group had, on average, a 3.33 greater point increase in their locomotor motor skills scores than children in the control group (β=3.33, p=0.009). No significant differences in effects were observed for object control, PA and food intake. However, results demonstrated a marginal increase in portions of fruits and vegetables served in the intervention group compared to control group (β=0.06, p=0.05). Conclusion: Locomotor skills showed a significant improvement in the intervention group compared to the control one. Although modest beneficial effects of HSDS were found, most outcome indicators progressed in a direction favouring the HSDS intervention compared to the usual practice group.

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

JMIR mhealth and uhealth ◽

10.2196/13747 ◽

2020 ◽

Vol 8 (2) ◽

pp. e13747 ◽

Cited By ~ 7

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. Trial Registration ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

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