Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.
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SUBMITTER: Lugones-Sanchez C
PROVIDER: S-EPMC8778755 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.
Lugones-Sánchez Cristina C Recio-Rodríguez José I JI Menéndez-Suárez Marta M Saz-Lara Alicia A Ramirez-Manent José I JI Sánchez-Calavera María A MA Gómez-Sánchez Leticia L Rodríguez-Sánchez Emiliano E García-Ortiz Luis L Evident Investigators Group
Nutrients 20220109 2
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 a ...[more]
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Project description:BackgroundMobile 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.ObjectiveThis 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.MethodsA 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.ResultsThe 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).ConclusionsThe 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.Trial registrationClinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.International registered report identifier (irrid)RR2-10.1097/MD.0000000000009633.
| S-EPMC7728540 | biostudies-literature
Project description:BACKGROUND:The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable alternative to in-person interventions for behavior change, especially with teens. PURPOSE:The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to 1) test whether supplementing the Aim2Be program with health coaching increases adherence and 2) examine the mediators and moderators of adherence to the Aim2Be intervention. METHODS:We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019-2020). Participants will be recruited from Canadian pediatric weight management clinics and through online advertisements. Child participants must be between the ages of 10 and 17 years, have overweight or obesity, be able to read English at least at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. After having their data collected for 3 months, the control group will gain access to Aim2Be, with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy. DISCUSSION:Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviors and guide future mHealth interventions for pediatric weight management. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.
| S-EPMC6998843 | biostudies-literature
Project description:BackgroundLow-carbohydrate ketogenic diets are a viable method to lose weight that have regained popularity in recent years. Technology in the form of mobile health (mHealth) apps allows for scalable and remote delivery of such dietary interventions and are increasingly being used by the general population without direct medical supervision. However, it is currently unknown which factors related to app use and user behavior are associated with successful weight loss.ObjectiveFirst, to describe and characterize user behavior, we aim to examine characteristics and user behaviors over time of participants who were enrolled in a remotely delivered clinical weight loss trial that tested an mHealth ketogenic diet app paired with a breath acetone biofeedback device. Second, to identify variables of importance to weight loss at 12 weeks that may offer insight for future development of dietary mHealth interventions, we aim to explore which app- and adherence-related user behaviors characterized successful weight loss.MethodsWe analyzed app use and self-reported questionnaire data from 75 adults with overweight or obesity who participated in the intervention arm of a previous weight loss study. We examined data patterns over time through linear mixed models and performed correlation, linear regression, and causal mediation analyses to characterize diet-, weight-, and app-related user behavior associated with weight loss.ResultsIn the context of a low-carbohydrate ketogenic diet intervention delivered remotely through an mHealth app paired with a breath acetone biofeedback device, self-reported dietary adherence seemed to be the most important factor to predict weight loss (β=-.31; t54=-2.366; P=.02). Furthermore, self-reported adherence mediated the relationship between greater app engagement (from c=-0.008, 95% CI -0.014 to -0.0019 to c'=-0.0035, 95% CI -0.0094 to 0.0024) or higher breath acetone levels (from c=-1.34, 95% CI -2.28 to -0.40 to c'=-0.40, 95% CI -1.42 to 0.62) and greater weight loss, explaining a total of 27.8% and 28.8% of the variance in weight loss, respectively. User behavior (compliance with weight measurements and app engagement) and adherence-related aspects (breath acetone values and self-reported dietary adherence) over time differed between individuals who achieved a clinically significant weight loss of >5% and those who did not.ConclusionsOur in-depth examination of app- and adherence-related user behaviors offers insight into factors associated with successful weight loss in the context of mHealth interventions. In particular, our finding that self-reported dietary adherence was the most important metric predicting weight loss may aid in the development of future mHealth dietary interventions.Trial registrationClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707.International registered report identifier (irrid)RR2-10.2196/19053.
| S-EPMC8961343 | biostudies-literature
Project description:BackgroundPrevalent co-occurring poor diet and physical inactivity convey chronic disease risk to the population. Large magnitude behavior change can improve behaviors to recommended levels, but multiple behavior change interventions produce small, poorly maintained effects.ObjectiveThe Make Better Choices 2 trial tested whether a multicomponent intervention integrating mHealth, modest incentives, and remote coaching could sustainably improve diet and activity.MethodsBetween 2012 and 2014, the 9-month randomized controlled trial enrolled 212 Chicago area adults with low fruit and vegetable and high saturated fat intakes, low moderate to vigorous physical activity (MVPA) and high sedentary leisure screen time. Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA simultaneously with, or sequentially after other diet and activity targets (N=84 per intervention) or a stress and sleep contact control intervention (N=44). They used a smartphone app and accelerometer to track targeted behaviors and received personalized remote coaching from trained paraprofessionals. Perfect behavioral adherence was rewarded with an incentive of US $5 per week for 12 weeks. Diet and activity behaviors were measured at baseline, 3, 6, and 9 months; primary outcome was 9-month diet and activity composite improvement.ResultsBoth simultaneous and sequential interventions produced large, sustained improvements exceeding control (P<.001), and brought all diet and activity behaviors to guideline levels. At 9 months, the interventions increased fruits and vegetables by 6.5 servings per day (95% CI 6.1-6.8), increased MVPA by 24.7 minutes per day (95% CI 20.0-29.5), decreased sedentary leisure by 170.5 minutes per day (95% CI -183.5 to -157.5), and decreased saturated fat intake by 3.6% (95% CI -4.1 to -3.1). Retention through 9-month follow-up was 82.1%. Self-monitoring decreased from 96.3% of days at baseline to 72.3% at 3 months, 63.5% at 6 months, and 54.6% at 9 months (P<.001). Neither attrition nor decline in self-monitoring differed across intervention groups.ConclusionsMulticomponent mHealth diet and activity intervention involving connected coaching and modest initial performance incentives holds potential to reduce chronic disease risk.Trial registrationClinicalTrials.gov NCT01249989; https://clinicaltrials.gov/ct2/show/NCT01249989 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01249989).
| S-EPMC6030572 | biostudies-literature
Project description:PurposeObesity increases the risk of cancer recurrence and death in survivors of breast cancer. This study tested the hypothesis that exercise alone, diet alone, and the combination of exercise plus diet reduce body weight and improve body composition in survivors of breast cancer.MethodsIn this 2 × 2 factorial trial, 351 survivors of breast cancer with overweight or obesity were randomized to one of four treatment groups for 52 weeks: control, exercise alone, diet alone, or exercise plus diet. Endpoints included body weight and body composition measured by dual-energy x-ray absorptiometry.ResultsAfter 52 weeks, compared with control, diet alone [- 5.39 kg (95% CI - 7.24, - 3.55);- 6.0% (95% CI - 8.0, - 3.9)] and exercise plus diet [- 6.68 kg (95% CI - 8.46, - 4.90);- 7.4% (95% CI - 9.4, - 5.4)] reduced body weight; exercise alone did not change body weight. Compared with control, diet alone [- 3.59 kg (95% CI - 5.00, - 2.17)] and exercise plus diet [- 4.28 kg (95% CI - 5.71, - 2.84)] reduced fat mass; exercise alone did not change fat mass. Compared with control, diet alone [- 0.82 kg (95% CI - 1.50, - 0.15)] and exercise plus diet [- 1.24 kg (95% CI - 1.92, - 0.56)] reduced lean mass; exercise alone did not change lean mass. Compared with control, exercise alone, diet alone, and exercise plus diet did not change bone mineral density.ConclusionIn survivors of breast cancer with overweight or obesity, diet alone or diet plus exercise produced clinically meaningful weight loss at week 52. The majority of weight loss was fat mass.
| S-EPMC8316406 | biostudies-literature
Project description:BackgroundPregnant patients with overweight or obesity are at high risk for perinatal complications. Excess gestational weight gain (GWG) further exacerbates this risk. Mobile health (mHealth) lifestyle interventions that leverage technology to facilitate self-monitoring and provide just-in-time feedback may motivate behavior change to reduce excess GWG, reduce intervention costs, and increase scalability by improving access.ObjectiveThis study aimed to test the acceptability and feasibility of a pilot mHealth lifestyle intervention for pregnant patients with overweight or obesity to promote moderate intensity physical activity (PA), encourage guideline-concordant GWG, and inform the design of a larger pragmatic cluster randomized controlled trial.MethodsWe conducted a mixed methods acceptability and feasibility randomized controlled trial among pregnant patients with a prepregnancy BMI of 25 to 40 kg/m2. Patients with singletons at 8 to 15 weeks of gestation who were aged ≥21 years and had Wi-Fi access were recruited via email from 2 clinics within Kaiser Permanente Northern California and randomized to receive usual prenatal care or an mHealth lifestyle intervention. Participants in the intervention arm received wireless scales, access to an intervention website, activity trackers to receive automated feedback on weight gain and activity goals, and monthly calls from a lifestyle coach. Surveys and focus groups with intervention participants assessed intervention satisfaction and ways to improve the intervention. PA outcomes were self-assessed using the Pregnancy Physical Activity Questionnaire, and GWG was assessed using electronic health record data for both arms.ResultsOverall, 33 patients were randomly assigned to the intervention arm, and 35 patients were randomly assigned to the usual care arm. All participants in the intervention arm weighed themselves at least once a week, compared with 20% (7/35) of the participants in the usual care arm. Participants in the intervention arm wore the activity tracker 6.4 days per week and weighed themselves 5.3 times per week, and 88% (29/33) of them rated the program "good to excellent." Focus groups found that participants desired more nutrition-related support to help them manage GWG and would have preferred an app instead of a website. Participants in the intervention arm had a 23.46 metabolic equivalent of task hours greater change in total PA per week and a 247.2-minute greater change in moderate intensity PA per week in unadjusted models, but these effects were attenuated in adjusted models (change in total PA: 15.55 metabolic equivalent of task hours per week; change in moderate intensity PA: 199.6 minutes per week). We found no difference in total GWG (mean difference 1.14 kg) compared with usual care.ConclusionsThe pilot mHealth lifestyle intervention was feasible, highly acceptable, and promoted self-monitoring. Refined interventions are needed to effectively affect PA and GWG among pregnant patients with overweight or obesity.Trial registrationClinicalTrials.gov NCT03936283; https://clinicaltrials.gov/ct2/show/NCT03936283.
| S-EPMC9260523 | biostudies-literature
Project description:BackgroundChildhood overweight and obesity have become major global health problems and are negatively related with the cardiorespiratory fitness (CRF) level in school children and adolescents. Exercise, specifically multicomponent training, is effective for CRF improvement, but the main challenge is to ensure adherence to exercise in children with overweight and obesity. Therefore, new ways of exercising that are more attractive and motivational for this population are needed and playing or training with active video games (AVGs) has been proposed as an effective alternative because they require full-body movement and therefore increase energy expenditure.ObjectiveThe main aim of this study was to investigate the effects of an AVG intervention combined with multicomponent training on CRF at maximal and submaximal intensities in children with overweight or obesity.MethodsWe recruited 28 children (13 girls and 15 boys) aged 9 to 11 years with overweight or obesity from medical centers and divided them into 2 groups, an intervention group (n=20) that participated in a 5-month supervised AVG exercise program combined with multicomponent exercise, and a control group (n=8) that continued daily activities without modification. A maximal stress test to measure CRF using a walking-graded protocol with respiratory gas exchange was performed by the participants.ResultsThe AVG group showed a significant decrease in heart rate and oxygen uptake for the same intensities in the submaximal stages of the maximal treadmill test, as well as a lower oxygen uptake percentage according to the individual maximal oxygen uptake, whereas the control group did not show overall changes. No change in the peak oxygen uptake (VO2peak) was found.ConclusionsA 5-month AVG intervention combined with multicomponent exercise had positive effects on CRF at submaximal intensity, showing a lower heart rate and oxygen uptake at the same intensities and displaying a lower oxygen uptake percentage according to the individual (VO2peak). Greater benefits were found in children with the highest fat percentage.Trial registrationClinicalTrials.gov NCT04418713; https://clinicaltrials.gov/show/NCT04418713.
| S-EPMC9175106 | biostudies-literature
Project description:BackgroundObesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group.MethodsSchool children from Copenhagen were randomly allocated to an intervention group (n = 19) or a control group (n = 19). Anthropometric assessment, whole body dual-energy X-ray absorptiometry scan, two hours oral glucose tolerance test, steps measured by pedometer, and fitness tests were measured at baseline and at 20 weeks.ResultsThirty-seven children (30 girls) participated at baseline, aged 8.7 ± 0.9 years with a BMI of 21.8 ± 3.7 kg/m2 (mean ± SD), and 36 children completed the study. The intervention group decreased their BMI (the intervention effect is the difference in change between the groups adjusted for the respective baseline values (DELTA) = -2.0 kg/m2, 95% CI: -2.5; -1.5, P <0.001), total body mass (DELTA = -4.0 kg, 95% CI: -4.9; -3.0, P <0.001), and fat mass (DELTA = -3.3 kg, 95% CI: -4.2; -2.7, P <0.001) compared to the control group after the intervention. The intervention group displayed decreased waist, hip and waist-to-height ratio (WHtR) (all three variables; P <0.001), area under curve for plasma insulin (P <0.05), and increased mean and minimum steps/day (P <0.05 and P <0.01, respectively).ConclusionsThe multicomponent intervention had significant favorable effects on BMI, weight, WHtR, mean and minimum steps/day, and fat mass. In addition, similar beneficial metabolic effects were found in the children as shown in adults, e.g. increase in peripheral insulin sensitivity.Trial registrationClinicaltrials.gov Identifier number NCT01660789.
| S-EPMC4287468 | biostudies-literature
Project description:Reach (i.e., proportion and representativeness of participants) of low-intensity, multicomponent childhood overweight/obesity interventions delivered in primary care settings with low-income and/or minority families is unknown. The purpose of this research is to describe the reach of a low-intensity, multicomponent childhood overweight/obesity intervention delivered in an integrated primary care setting in a federally qualified health center (FQHC). Eligibility criteria included children aged 4-10 years with a body mass index (BMI) ≥85th percentile, with a female caregiver. Using the electronic health record (EHR) and release forms, families were broadly categorized into groupings from recruitment flow, with differing proportions calculated from these groupings. Representativeness was determined using EHR data from families who were informed about the program (n = 963). Three calculated reach rates ranged from 54.9% to 3.9%. Lower reach rates were calculated using the number of families randomized (n = 73) as the numerator and the children from families who were informed about the program (n = 963) or all eligible children in the FQHC attending appointments (n = 1,864) as denominators. The first two steps in recruitment, informing families about the program and families initiating participation, were where the largest decreases in reach occurred. Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic. Reach of the intervention was low. Strategies that assist with reducing time for informing families of treatment and increasing families' awareness of their child's weight status should assist with enhancing reach.
| S-EPMC7413189 | biostudies-literature
Project description:BackgroundIn clinical practice, it is difficult to convey the benefits of sustained physical activity to adult patients with excess weight or obesity. For this purpose, a goal-setting walking prescription may be an effective strategy.ObjectiveThis study aimed to determine the efficacy of the intervention of a pedometer app in setting a goal to reach 10,000 steps per day in adults.MethodsOverweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2) were randomized to one of two conditions (control or intervention). Both groups downloaded a pedometer app that recorded their daily step counts and were given a daily walking goal of 10,000 steps. Subjects participated in a 24-week in-person behavioral weight control program and were asked to monitor their daily levels using the pedometer app. Baseline data were recorded and followed up weekly. Only the intervention group had structured information delivery, a personalized physical activity prescription, and follow-up on number of steps per day.ResultsThe results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized β coefficient=-0.813, SE=427.586, t=-11.242, P<.001).ConclusionsThese results could have implications for improving self-monitoring in overweight adults during periods of weight loss. Health professionals should analyze the implementation of tools that permit them to prescribe, follow up, and encourage the achievement of a goal of physical activity in overweight or obese patients.Trial registrationClinicalTrials.gov NCT03845478; https://clinicaltrials.gov/ct2/show/NCT03845478.
| S-EPMC7287728 | biostudies-literature