Effect of an mHealth-Based Intervention on Excessive Gestational Weight Gain Prevention among Overweight and Obese Women: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Hung Hui Chen ◽  
Ching-Fang Lee ◽  
Jian-Pei Huang ◽  
Li-Kang Chi ◽  
Yvonne Hsiung

BACKGROUND Excessive gestational weight gain (GWG) is a public health concern since it can lead to adverse consequences and health problems for expecting mothers and their unborn infants. There is a need to evaluate the effects of a GWG management intervention to reduce the burden and risk among overweight and obese women during pregnancy. OBJECTIVE To explore the efficacy of a mobile health (mHealth) intervention to prevent excessive GWG, overweight and obese pregnant women were invited to use an app and wearable activity tracker (WAT). METHODS A randomized controlled trial with an experimental study design. Ninety-two pregnant women were recruited, and all overweight and obese participants from the two prenatal outpatient clinics in northern Taiwan had, at less than 17 weeks gestation, a prepregnancy body mass index (BMI) ≥ 25 kg/m2. These participants were randomly assigned (1:1) by a random number table; the experimental group received an mHealth-based program using the MyHealthyWeight (MHW) app and a WAT to wear during pregnancy. The control group received standard antenatal treatments without any mHealth-based elements. Two hospital follow-up visits were scheduled at 24-26 weeks in the second trimester and 34-36 weeks in the third trimester. Sociodemographic characteristics, pregnancy physical activity questionnaire (PPAQ), a self-efficacy questionnaire and body weight were measures of interest. A generalized estimating equation (GEE) was used to examine the trajectories and the intervention effect on GWG. RESULTS No difference in GWG was found between the intervention and control groups at baseline. The weight gain trajectory in the entire cohort of women with obesity exhibited a quadratic pattern; compared with the control group, a slight increase in the intervention group was found in the second trimester. Throughout the whole pregnancy, the mHealth intervention group had a significantly lower proportion of excessive GWG in total and weekly weight gain. In particular, obese women in the intervention group, compared with obese women in the control group, gained less weight (average difference of 8.76 kg) in the third trimester. The GEE model indicated that obese women who were aged 35 years, had prepregnancy exercise habits, had perceived self-efficacy of diet, and had more physical activity had lower GWG (p<.05). CONCLUSIONS The mHealth program has shown positive results in significantly managing GWG among obese and overweight women. Among obese women, the second semester trajectory of weight gain and the lower proportion of excessive GWG were more notable than those of overweight women. Although the intervention seems to be more effective among women with obesity, our results show the potential to prevent excessive GWG during pregnancy in both overweight and obese women. Guidance may be provided to health-care professionals who wish to promote healthy diet and physical activity behaviors. CLINICALTRIAL The protocol of the study was registered in ClinicalTrials. gov (NCT04553731).

Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  

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; <i>P</i>&lt;.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; <i>P</i>&lt;.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; <i>P</i>&gt;.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


Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1428
Author(s):  
Hannah Holmes ◽  
Cristina Palacios ◽  
YanYan Wu ◽  
Jinan Banna

Objectives: The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on excessive gestational weight gain (GWG) in a low-income, predominantly overweight/obese population. Methods: Participants (n = 83) were mostly overweight/obese women recruited at Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics on the island of O’ahu, Hawai’i at 15–20 weeks gestational age. The intervention group received SMS on nutrition and physical activity during pregnancy designed to help them meet Institute of Medicine (IOM) guidelines for GWG and American College of Obstetricians and Gynecologists guidelines for exercise, respectively. The control group received SMS about general health topics during pregnancy, excluding nutrition and physical activity. Both groups received one text message per week for eighteen weeks. GWG was defined as the difference between the last self-reported weight taken before delivery and participants’ self-reported weight before pregnancy. Differences between study groups were examined using t-tests and Chi-square tests. Linear regression models were used to examine association of GWG with study group and other factors. Results: GWG was similar (p = 0.58) in the control group (14.1 ± 11.4 kg) and the intervention group (15.5 ± 11.6 kg). The percentage of participants exceeding IOM guidelines for GWG was similar (p = 0.51) in the control group (50.0%, n = 17) and the intervention group (60.5%, n = 23). Conclusions: GWG was not significantly different between intervention and control groups. Trials that begin earlier in pregnancy or before pregnancy with longer intervention durations and varying message frequency as well as personalized or interactive messages may be needed to produce significant improvements.


10.2196/13747 ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. e13747 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  

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


Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  

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.


2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.


2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  

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


2017 ◽  
Vol 32 (3) ◽  
pp. 795-805 ◽  
Author(s):  
Laura Viester ◽  
Evert A. L. M. Verhagen ◽  
Paulien M. Bongers ◽  
Allard J. van der Beek

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.


2021 ◽  
pp. 1356336X2110374
Author(s):  
Stephanie Rosenstiel ◽  
Carmen Volk ◽  
Julia Schmid ◽  
Wolfgang Wagner ◽  
Yolanda Demetriou ◽  
...  

A central goal of physical education (PE) is to empower students to be physically active in a health-enhancing way. Therefore, using a competence-based approach, the objective of the health- and fitness-related PE intervention ‘Promotion of physical activity-related health competence in PE’ (GEKOS) was to address practical and theoretical content regarding training, fitness, and health. The aim of this person-oriented study was to examine differential effects of the GEKOS intervention on control competence and related knowledge, skills, abilities, and motivation. A total of 860 ninth graders were randomly assigned to an intervention or control group. Intervention group students received six PE lessons that combined practical and theoretical content regarding training, fitness, and health. Measurements were taken before, directly after, and with a follow-up after 8–12 weeks. Students completed a knowledge test and a fitness test, and filled out scales considering motivation and perceived control competence. Latent profile analysis and multinomial logistic regression were estimated. Five patterns of outcome measures were found. Intervention group students transitioned significantly more often to patterns with improved outcome values. The intervention was especially effective for a subgroup of students who initially had rather low outcome values. For a small proportion of students, the intervention entailed a loss of health-related motivation. The study indicated that students with low control competence and related knowledge, skills, abilities, and motivation can benefit from the GEKOS intervention. Future studies should investigate modes of actions and interventions that explicitly address motivation and vary the content and methods used in PE.


Nutrients ◽  
2022 ◽  
Vol 14 (2) ◽  
pp. 270
Author(s):  
Cristina Lugones-Sánchez ◽  
José I. Recio-Rodríguez ◽  
Marta Menéndez-Suárez ◽  
Alicia Saz-Lara ◽  
José I. Ramirez-Manent ◽  
...  

A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (−30.8; 95% CI −59.9, −1.7) and full-fat dairies (−23.3; 95% CI −42.8, −3.8) and increased the intake of wholemeal bread (3.3; 95% CI −6.7, 13.3) and whole-grain cereals (3.4; 95% CI −6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.


Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Kelsie M Full ◽  
Katie Crist ◽  
Marta Jankowska ◽  
Pamela L Lutsey ◽  
Loki Natarajan

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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