The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.
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ABSTRACT: Background
Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors.Purpose
Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older.Methods
Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months.Conclusions
If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.
SUBMITTER: Burke LE
PROVIDER: S-EPMC7269678 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSelf-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials.ObjectiveThe aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2.MethodsAll participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal).ResultsParticipants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001).ConclusionsThere were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools.Trial registrationClinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.
| S-EPMC9297147 | biostudies-literature
Project description:Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (- 2.85% vs. - 3.14% vs. - 3.37%) (p = 0.95); 26% of the participants lost ≥ 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.
| S-EPMC5388931 | biostudies-literature
Project description:The SenseWear™ Armband (SWA) (BodyMedia, Inc. Pittsburgh, PA) is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes.We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI), 33.3 ± 5.2 kg/m(2); 81% women, 32% African-American) from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50), a group-based behavioral weight loss program (GWL, n = 49), the armband alone (SWA-alone, n = 49), or the GWL plus the armband (GWL+SWA, n = 49), during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave.Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention). There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P < 0.0001) but not in the Standard Care group (0.89 kg, P = 0.39) at month 9. Only the GWL+SWA group achieved significant weight loss at month 9 compared to the Standard Care group (P = 0.04). Significant waist circumference reductions were achieved in all 4 groups at month 9 (Standard Care, 3.49 cm, P = 0.0004; GWL, 2.42 cm, P = 0.008; SWA-alone, 3.59 cm, P < 0.0001; GWL+SWA, 6.77 cm, P < 0.0001), but no intervention group had significantly reduced waist circumference compared to the Standard Care group.Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss.
| S-EPMC3112373 | biostudies-literature
Project description:BACKGROUND:Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. OBJECTIVE:The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. METHODS:The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants' PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. RESULTS:Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. CONCLUSIONS:We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. TRIAL REGISTRATION:ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/19213.
| S-EPMC7367531 | biostudies-literature
Project description:BackgroundGiven the increase in the prevalence of overweight and obesity worldwide, the number of digital weight loss interventions has also risen. However, these interventions often lack theoretical background and data on long-term effectiveness. The consideration of individual and gender differences in weight-related psychological parameters might enhance the efficacy and sustainability of mobile-based weight loss interventions.ObjectiveThis paper presented an introduction to and the process evaluation of a 12-week gender-sensitive mobile health (mHealth) weight loss intervention (I-GENDO) combining computer-based and self-tailoring features.MethodsBetween August 2020 and August 2021, individuals with overweight (BMI 25.0-29.9 kg/m²), those with obesity class I (BMI 30.0-34.9 kg/m²), and those with obesity class II (BMI 35.0-39.9 kg/m²) were recruited to the I-GENDO project, a multicenter study in Germany. The mHealth intervention aimed at targeting individual psychological factors associated with the development and persistence of overweight and obesity (eg, emotional eating) using computer-based tailoring. Moreover, the intervention took a gender-sensitive approach by implementing self-tailoring of gender-targeted module versions. The computer-based assignment of the main modules, self-selection of gender-targeted module versions, and use patterns were evaluated while considering gender. Moreover, gender differences in the usability assessment were analyzed.ResultsData from the intervention arm of the study were processed. A total of 116 individuals with overweight and obesity (77/116, 66.4% women; age mean 47.28, SD 11.66 years; BMI mean 33.58, SD 3.79 kg/m2) were included in the analyses. Overall, the compliance (90/109, 82.6%) and satisfaction with the app (mean 86% approval) were high and comparable with those of other mobile weight loss interventions. The usability of the intervention was rated with 71% (5.0/7.0 points) satisfaction. More women obtained the main module that focused on emotion regulation skills. Most men and women selected women-targeted versions of the main modules. Women used the app more frequently and longer than men. However, women and men did not differ in the progress of use patterns throughout the intervention.ConclusionsWe developed a tailored gender-sensitive mHealth weight loss intervention. The usability of and engagement with the intervention were satisfactory, and the overall satisfaction with the intervention was also high. Gender differences must be considered in the evaluation of the effectiveness and sustainability of the intervention.
| S-EPMC9650578 | biostudies-literature
Project description:BACKGROUND:Electronic health (eHealth) and mobile health (mHealth) approaches to address low physical activity levels, sedentary behavior, and unhealthy diets have received significant research attention. However, attempts to systematically map the entirety of the research field are lacking. This gap can be filled with a bibliometric study, where publication-specific data such as citations, journals, authors, and keywords are used to provide a systematic overview of a specific field. Such analyses will help researchers better position their work. OBJECTIVE:The objective of this review was to use bibliometric data to provide an overview of the eHealth and mHealth research field related to physical activity, sedentary behavior, and diet. METHODS:The Web of Science (WoS) Core Collection was searched to retrieve all existing and highly cited (as defined by WoS) physical activity, sedentary behavior, and diet related eHealth and mHealth research papers published in English between January 1, 2000 and December 31, 2016. Retrieved titles were screened for eligibility, using the abstract and full-text where needed. We described publication trends over time, which included journals, authors, and countries of eligible papers, as well as their keywords and subject categories. Citations of eligible papers were compared with those expected based on published data. Additionally, we described highly-cited papers of the field (ie, top ranked 1%). RESULTS:The search identified 4805 hits, of which 1712 (including 42 highly-cited papers) were included in the analyses. Publication output increased on an average of 26% per year since 2000, with 49.00% (839/1712) of papers being published between 2014 and 2016. Overall and throughout the years, eHealth and mHealth papers related to physical activity, sedentary behavior, and diet received more citations than expected compared with papers in the same WoS subject categories. The Journal of Medical Internet Research published most papers in the field (9.58%, 164/1712). Most papers originated from high-income countries (96.90%, 1659/1717), in particular the United States (48.83%, 836/1712). Most papers were trials and studied physical activity. Beginning in 2013, research on Generation 2 technologies (eg, smartphones, wearables) sharply increased, while research on Generation 1 (eg, text messages) technologies increased at a reduced pace. Reviews accounted for 20 of the 42 highly-cited papers (n=19 systematic reviews). Social media, smartphone apps, and wearable activity trackers used to encourage physical activity, less sedentary behavior, and/or healthy eating were the focus of 14 highly-cited papers. CONCLUSIONS:This study highlighted the rapid growth of the eHealth and mHealth physical activity, sedentary behavior, and diet research field, emphasized the sizeable contribution of research from high-income countries, and pointed to the increased research interest in Generation 2 technologies. It is expected that the field will grow and diversify further and that reviews and research on most recent technologies will continue to strongly impact the field.
| S-EPMC5932335 | biostudies-other
Project description:BackgroundWeb-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues.ObjectiveThis study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with overweight or obesity.MethodsParent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children's weight loss goals (session contents included energy balance, fast food, fruits and vegetables, physical activity [PA], sedentary behavior, and sweetened beverages). MVPA was measured using accelerometers at baseline and after the intervention.ResultsUsing a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA (B=-12.561, 95% CI -18.759 to -6.367), but MVPA increased with greater log-in duration for the PA (B=0.008, 95% CI 0.004-0.012) and sedentary behavior (B= 0.008, 95% CI 0.004-0.012) sessions. These results suggest that parents who logged in to the PA session had lower MVPA, but MVPA increased with greater log-in duration for the PA and sedentary behavior sessions. These associations remained even after accounting for engagement with other content sessions. However, these engagement effects did not translate to the adolescents.ConclusionsThe results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families.Trial registrationClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067.
| S-EPMC10134014 | biostudies-literature
Project description:BackgroundComputerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. This study examined the effect of computerized tailored physical activity reports on primary care patients' physical activity at 6 months.DesignTwo-group randomized clinical trial with physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment.Setting/participantsPrimary care physicians (n=22) and their adult patients (n=394) from Philadelphia PA. The study and analyses were conducted from 2004 to 2010.InterventionThe intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.Main outcome measuresMinutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months.ResultsParticipants were 69% female, 59% African-American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, there were no differences in physical activity at 6 months. The intervention group increased their total physical activity by a mean of 139 minutes; the control group had a mean increase of 109 minutes (p=0.45).ConclusionsAlthough physical activity increased within both groups, computerized tailored physical activity reports did not significantly increase physical activity between groups at 6 months among ethnically and socioeconomically diverse adults in primary care.
| S-EPMC3140844 | biostudies-literature
Project description:Background: Routine outcome monitoring (ROM) has been implemented across a range of addiction treatment services, settings and organisations. Mutual support groups are a notable exception. Innovative solutions are needed. SMART Track is a purpose built smartphone app designed to capture ROM data and provide tailored feedback to adults attending Australian SMART Recovery groups for addictive behaviour(s). Objective: Details regarding the formative stage of app development is essential, but often neglected. Improved consideration of the end-user is vital for curtailing app attrition and enhancing engagement. This paper provides a pragmatic example of how principles embedded in published frameworks can be operationalised to address these priorities during the design and development of the SMART Track app. Methods: Three published frameworks for creating digital health technologies ("Person-Based Approach," "BIT" Model and IDEAS framework) were integrated and applied across two stages of research to inform the development, design and content of SMART Track. These frameworks were chosen to ensure that SMART Track was informed by the needs and preferences of the end-user ("Person-Based"); best practise recommendations for mHealth development ("BIT" Model) and a collaborative, iterative development process between the multi-disciplinary research team, app developers and end-users (IDEAS framework). Results: Stage one of the research process generated in-depth knowledge to inform app development, including a comprehensive set of aims (clinical, research/organisation, and usage); clear articulation of the target behaviour (self-monitoring of recovery related behaviours and experiences); relevant theory (self-determination and social control); appropriate behavioural strategies (e.g., behaviour change taxonomy and process motivators) and key factors that may influence engagement (e.g., transparency, relevance and trust). These findings were synthesised into guiding principles that were applied during stage two in an iterative approach to app design, content and development. Conclusions: This paper contributes new knowledge on important person-centred and theoretical considerations that underpin a novel ROM and feedback app for people with addictive behaviour(s). Although person-centred design and best-practise recommendations were employed, further research is needed to determine whether this leads to improved usage outcomes. Clinical Trial Registration: Pilot Trial: http://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336.
| S-EPMC8249767 | biostudies-literature
Project description:BackgroundA healthy diet and a sufficient amount of physical activity are important factors to reduce complications of type 2 diabetes. Diet and physical activity are associated behaviours. Individuals who are physically active have also been shown to have healthier eating habits than sedentary individuals. We aimed to evaluate the indirect effect of a smartphone-based physical activity intervention on dietary habits in patients with type 2 diabetes.MethodsWe performed analyses of secondary outcomes in a randomized controlled trial. The active intervention was use of a smartphone application to promote physical activity during 12 weeks. Dietary intake was assessed at baseline and after three months using a validated semi-quantitative food frequency questionnaire comprising 94 items. We analysed changes in the intake of fruit and vegetables, snacks, fibre, whole grains, vitamin C, saturated fat, unsaturated fat and total energy. We also assessed overall dietary habits using a dietary index developed by the Swedish National Board of Health and Welfare. Results were compared between the intervention and control group, as well as stratified by sex within the study groups. Paired t-tests and analysis of covariance were performed.ResultsA total of 181 patients were recruited to the DiaCert-study, whereof 146 patients had complete dietary data and were included in the analyses. Women in the intervention group had a higher fruit and vegetable intake (p = 0.008) and a higher dietary index (p = 0.007), at three-months compared to women in the control group. They had increased their daily intake of fruit and vegetables by on average 87.4 g/day (p = 0.04) and improved their dietary index by on average 0.8 points (p = 0.01) from baseline to follow-up. No effect was found in men.ConclusionsWomen, but not men, receiving a smartphone-based physical activity intervention improved their total intake of fruit and vegetables. The transfer effect, i.e. an intervention aimed at promoting one health behavior that facilitates changes in other health behaviors, may differ between the sexes.Trial registrationClinicalTrials.gov Identifier: NCT03053336; 15/02/2017.
| S-EPMC9893597 | biostudies-literature