Efficacy of SmartLoss, a smartphone-based weight loss intervention: results from a randomized controlled trial.
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SUBMITTER: Martin CK
PROVIDER: S-EPMC4414058 | biostudies-literature | 2015 May
REPOSITORIES: biostudies-literature
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Efficacy of SmartLoss, a smartphone-based weight loss intervention: results from a randomized controlled trial.
Martin Corby K CK Miller Anastasia C AC Thomas Diana M DM Champagne Catherine M CM Han Hongmei H Church Timothy T
Obesity (Silver Spring, Md.) 20150501 5
<h4>Objective</h4>Test the efficacy of SmartLoss, a smartphone-based weight loss intervention, in a pilot study.<h4>Design and methods</h4>A 12-week randomized controlled trial. Adults (25 ≤ BMI ≤ 35 kg/m2) were randomized to SmartLoss (n = 20) or an attention-matched Health Education control group (n = 20). SmartLoss participants were prescribed a 1,200 to 1,400 kcal/d diet and were provided with a smartphone, body weight scale, and accelerometer that wirelessly transmitted body weight and step ...[more]
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Project description:BACKGROUND:Laboratory studies suggest that eating more 'attentively' (e.g. attending to food being eaten and recalling eating episodes) can reduce food intake among participants with both healthy weight and overweight. The aim of this trial was to assess whether a smartphone application that encourages a more attentive eating style reduces energy intake and promotes weight loss. METHODS:In an open-label, single centre, parallel groups, individually randomised controlled trial, 107 adults with overweight/obesity in Merseyside, UK used an attentive eating smartphone application along with standard dietary advice (intervention group) or standard dietary advice only (control group) for 8?weeks. The primary outcomes were change in body weight at 8?weeks and energy intake at 4 and 8?weeks. Additional outcomes included self-reported eating behaviours measured at 8?weeks. Differences between groups were assessed with linear regression (adjusted) using multiple imputation for missing data. Study protocol registered prospectively at ( https://doi.org/10.17605/osf.io/btzhw ). RESULTS:There was no significant difference between the intervention and control group in weight lost at 8?weeks, or change in self-reported 24?h or objective taste-test energy intake at 4 or 8?weeks. Mean weight loss in the intervention group (n?=?53) was 1.2?kg and 1.1?kg in the control group (n?=?54), adjusted difference of -?0.10 (-?1.6 to 1.3) kg. Self-reported eating behaviours at 8?weeks also did not differ across groups. The intervention was largely used as intended and a per protocol analysis confined to participants in the intervention group that used the attentive eating smartphone application regularly and as intended also showed no effect on energy intake or weight loss. CONCLUSIONS:A smartphone based attentive eating intervention and standard dietary advice did not result in reduced energy intake or greater weight loss at 4 or 8?week follow-up than standard dietary advice alone. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03602001 . Registered retrospectively on 26th July 2018. Prospectively registered on the Open Science Framework on 11th August 2017.
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Project description:ObjectivesMost electronically delivered lifestyle interventions are labor intensive, requiring logging onto websites and manually recording activity and diet. Cumbersome technology and lack of a human coach may have contributed to the limitations of prior interventions. In response, the current program of research created a comprehensive electronically delivered lifestyle intervention using a user-friendly, interactive, smartphone app-based model, and evaluated it in a randomized controlled trial.MethodsTwenty-eight adults, body mass index 25-42 kg/m2, with smartphones and sedentary jobs, were randomized to the intervention, along with conventional outpatient weight-management visits every 3 months, or to a wait-listed control group that received only weight-management visits. The intervention included wearable activity trackers, smartscales, food photography logs, physician-driven app-based behavioral coaching, and peer support via the app. The prespecified primary outcome was a comparison of change in weight in kilograms, in the intervention versus control group at 6 months.ResultsAt 6 months, the intervention group experienced a statistically significant weight change of -7.16 ± 1.78 kg (mean ± SE, 95% CI -11.05 to -3.26, p < 0.01), which differed from the weight change in controls by -4.16 ± 2.01 kg (95% CI -8.29 to -0.02, p < 0.05, prespecified primary outcome). Weight change in the control group was -3.00 ± 1.05 kg (95% CI -5.27 to -0.73, p < 0.05). Waist circumference and hemoglobin A1c significantly improved (intervention vs. control: p < 0.01, p < 0.05, respectively, prespecified secondary outcomes). Weight change in the intervention group correlated with numbers of food photographs participants shared (rho = -0.86, p < 0.01), numbers of their text messages (rho = -0.80, p < 0.01), number of times and days each participant stepped on the smartscale (rho = -0.73, p < 0.01; rho = -0.608, p < 0.05, respectively), and mean daily step counts (rho = -0.55, p < 0.05).ConclusionThis app-based electronically delivered lifestyle intervention produced statistically significant, clinically meaningful weight loss and improved metabolic health. Engagement with the intervention correlated strongly with weight loss. Given the limited sample size, larger and longer studies of this intervention are needed.
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Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).
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Project description:To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.This paper describes the development and evaluation of a text message-based intervention designed to help individuals lose or maintain weight over 4 months.The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (-1.97 kg difference, 95% CI -0.34 to -3.60 kg, P = .02) after adjusting for sex and age. Intervention participants' adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.
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Project description:OBJECTIVE:The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity. METHODS:This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI?=?25.0-49.9?kg/m2 to 16 weeks of BWL (n?=?54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n?=?56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models. RESULTS:Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs.?+?0.9 [-0.4 to 2.2], P?<?0.001) and follow-up (-3.2 [-2.0 to -4.5] vs.?+?1.1 [-0.2 to 2.4], P?<?0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P?=?0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P?=?0.378). CONCLUSIONS:Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits.
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| S-EPMC8078064 | biostudies-literature
Project description:We recently reported that a 12-week diet intervention among postpartum women produced a weight loss of 12% after 1 year, compared to 5% in controls. Here, we present 2-year results after 1 year of unsupervised follow-up. In total, 110 women with a self-reported body mass index of ≥27 kg/m2 at 6-15-week postpartum were randomized to diet group (D-group) or control group (C-group). D-group received a 12-week diet intervention by a dietitian followed by monthly e-mails up to the 1-year follow-up. C-group received a brochure on healthy eating. No contact was provided from 1 to 2 years to either group. Eighty-nine women (81%) completed the 2-year follow-up. Median (1st; 3rd quartile) weight change from 0 to 2 years was -6.9 (-11.0; -2.2) kg in D-group and -4.3 (-8.7; -0.2) kg in C-group. There was no group by time interaction at 2 years (p = .082); however, when women with a new pregnancy between 1 and 2 years were excluded, the interaction became significant (-8.2 vs. -4.6 kg, p = .038). From 1 to 2 years, women in D- and C-group gained 2.5 ± 5.0 kg and 1.1 ± 4.4 kg, respectively (p = .186). Women who gained weight from 1 to 2 years reported a decrease in self-weighing frequency compared to women who maintained or lost weight (p = .008). Both groups achieved clinically relevant 2-year weight loss, but the significant between-group-difference observed at 1 year was not maintained at 2 years in the main analysis. However, when women with a new pregnancy between 1 and 2 years were excluded, a significant weight loss effect was observed also at 2 years.
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Project description:BackgroundAvailable smartphone-based interventions for depression predominantly use evidence-based strategies from cognitive-behavioral therapy (CBT), but patient engagement and reported effect sizes are small. Recently, studies have demonstrated that smartphone-based interventions combining CBT with gamified approach-avoidance bias modification training (AAMT) can foster patient engagement and reduce symptoms of several mental health problems.ObjectiveBased on these findings, we developed a gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), and hypothesized the program would both engage patients and produce preliminary evidence for the reduction of depressive symptoms.MethodsTo test this hypothesis, we evaluated MT-Phoenix in a randomized controlled pilot trial including 77 individuals with elevated depression scores (Patient Health Questionnaire-9 scores ≥5). Participants were either instructed to train for 14 days with MT-Phoenix or assigned to a waitlist control condition. Engagement with the intervention was measured by assessing usage data. The primary outcome was reduction in depressive symptom severity at postassessment.ResultsData from this pilot trial shows that participants in the intervention group used the smartphone-based intervention for 46% of all days (6.4/14) and reported a significantly greater reduction of depressive symptoms than did participants in the control condition (F1,74=19.34; P=.001), with a large effect size (d=1.02). Effects were sustained at a 3-month follow-up.ConclusionsA gamified smartphone-based intervention combining CBT with AAMT may foster patient engagement and effectively target depressive symptoms. Future studies should evaluate the effectiveness of this intervention in a phase 3 trial using clinical samples. Moreover, the intervention should be compared to active control conditions.Trial registrationGerman Clinical Trial Registry DRKS00012769; https://tinyurl.com/47mw8du7.
| S-EPMC8335612 | biostudies-literature
Project description:BACKGROUND:Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app-based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. OBJECTIVE:This study aims to evaluate the effectiveness of a self-guided mobile app-based psychological intervention for people providing care to family or friends with a physical or mental disability. METHODS:In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. RESULTS:In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=-2.07; P=.04) and depressive symptoms (b=-1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=-1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=-0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). CONCLUSIONS:This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. TRIAL REGISTRATION:Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170.
| S-EPMC7414413 | biostudies-literature
Project description:BackgroundThere is certain evidence on the efficacy of smartphone-based mental health interventions. However, the mechanisms of action remain unclear. Placebo effects contribute to the efficacy of face-to-face mental health interventions and may also be a potential mechanism of action in smartphone-based interventions.ObjectiveThis study aimed to investigate whether different types of efficacy expectancies as potential factors underlying placebo effects could be successfully induced in a smartphone-based digital placebo mental health intervention, ostensibly targeting mood and stress.MethodsWe conducted a randomized, controlled, single-blinded, superiority trial with a multi-arm parallel design. Participants underwent an Android smartphone-based digital placebo mental health intervention for 20 days. We induced prospective efficacy expectancies via initial instructions on the purpose of the intervention and retrospective efficacy expectancies via feedback on the success of the intervention at days 1, 4, 7, 10, and 13. A total of 132 healthy participants were randomized to a prospective expectancy-only condition (n=33), a retrospective expectancy-only condition (n=33), a combined expectancy condition (n=34), or a control condition (n=32). As the endpoint, we assessed changes in efficacy expectancies with the Credibility Expectancy Questionnaire, before the intervention and on days 1, 7, 14, and 20. For statistical analyses, we used a random effects model for the intention-to-treat sample, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs no) and retrospective expectancy (yes vs no), allowed to vary over participant and intervention day.ResultsCredibility (?=-1.63; 95% CI -2.37 to -0.89; P<.001) and expectancy (?=-0.77; 95% CI -1.49 to -0.05; P=.04) decreased across the intervention days. For credibility and expectancy, we found significant three-way interactions: intervention day×prospective expectancy×retrospective expectancy (credibility: ?=2.05; 95% CI 0.60-3.50; P=.006; expectancy: ?=1.55; 95% CI 0.14-2.95; P=.03), suggesting that efficacy expectancies decreased least in the combined expectancy condition and the control condition.ConclusionsTo our knowledge, this is the first empirical study investigating whether efficacy expectancies can be successfully induced in a specifically designed placebo smartphone-based mental health intervention. Our findings may pave the way to diminish or exploit digital placebo effects and help to improve the efficacy of digital mental health interventions.Trial registrationClinicaltrials.gov NCT02365220; https://clinicaltrials.gov/ct2/show/NCT02365220.
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