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Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial.

ABSTRACT: Conventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider. It is unclear to what extent conventional programs can be (partially) completed by mobile health (mHealth) apps.The aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight (body mass index [BMI]>29 kg/m²).A single-blinded randomized controlled trial among obese adults was performed from September 2015 to March 2016. The study took place in Leuven, Belgium. Of the 102 eligible (BMI >29 kg/m²) adults, 81 (79%) completed the study. The three intervention groups consisted of a conventional face-to-face weight loss program, a weight loss app program (app group), and a partial face-to-face and partial app program (combi group). All intervention groups received the same advice from a dietician and a physical activity coach during a 12-week period. The control group did not receive any information during the same period. Primary outcomes were weight reduction (5% decrease of baseline weight in kg), BMI, metabolic risk factors, dietary pattern, and physical activity.Significant more participants in all three intervention groups lost at least 5% or more of their weight at baseline compared with the control group. No significant difference was found between the combi group and the conventional group. A trend was found that more participants in the combi group lost 5% or more compared with the app group (19%), P=.06. A significant time x group effect was found for BMI and metabolic risk factors, with the control group having the worst results and the combi group being significantly better with regard to BMI compared with the app group. No significant group x time effects were found for the intake of different food and drinks and moderate to vigorous physical activity (MVPA).The results of this study show that a conventional weight loss program could partially be completed with an mHealth program without affecting the effectiveness.Clinicaltrials.gov NCT02595671; https://clinicaltrials.gov/ct2/show/NCT02595671 (Archived by WebCite at http://www.webcitation.org/6w1H0x1Q6).

SUBMITTER: Hurkmans E

PROVIDER: S-EPMC5785684 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial.

Hurkmans Emalie E Matthys Christophe C Bogaerts An A Scheys Leonie L Devloo Karlien K Seghers Jan J

JMIR mHealth and uHealth 20180111 1

<h4>Background</h4>Conventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider. It is unclear to what extent conventional programs can be (partially) completed by mobile health (mHealth) apps.<h4>Objective</h4>The aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight (body mass index [BMI]>29 kg/m²).<h4>Methods ...[more]

PMID: 29326093

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Project description:Mobile phone apps may be acceptable to users and could improve retention and adherence over more traditional methods, but there is mixed literature supporting their efficacy. In the weight management space, very little is known about how a mobile phone app integrating features beyond text messaging (short message service) can affect behavior, particularly when combined with face-to-face support.The objective of this study was to examine the effectiveness of a mobile phone app when combined with a partial meal replacement program including face-to-face support. This paper compares a static versus supportive app over a 6-month randomized trial for effects on weight loss, weight-related biomarkers, and psychological outcomes.Overweight and obese adults (71.2% female, 104/146; mean 48.11, SD 11.75 years) were recruited to participate in the weight loss study, and they were randomized on a 1:1 basis using a computer algorithm. The supportive app (n=75) provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app (n=71) included only recipes and weight loss information. Both groups recieved equal amounts of face-to-face support in addition to app.The overall reduction in app usage over 24 weeks was lower for the supportive app in comparison with the static app; approximately 39.0% (57/146) of the users were still using the app at week 24. Despite the promising results for app usage, there were no differences in weight loss between groups (F1,128.12=0.83, P=.36). However, it should be noted that almost 60% (49/84) of all participants lost 5% or more of body weight during the trial. No weight-related biomarkers were significantly different between groups. Both groups experienced an increase in positive mood, but this was significantly higher for those who received the static app (F1,118.12=4.93, P=.03).Although the supportive app was well received by users, we found little evidence of the added benefit of this versus the static app in combination with face-to-face support in a community-delivered weight loss program. Future versions of the app may incorporate more unique behavioral techniques beyond those provided by the consultant to improve the potency of the app.Australian New Zealand Clinical Trials Registry ACTRN12613000547741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364187 (Archived by WebCite http://www.webcitation.org/6yivwfMI9).

Project description:BACKGROUND:Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder. METHODS/DESIGN:The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable. DISCUSSION:This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted. TRIAL REGISTRATION:ClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

Project description:BACKGROUND:Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE:This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS:A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS:We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. CONCLUSIONS:Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. TRIAL REGISTRATION:University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

Project description:IntroductionWe explored the working alliance as measured by both clients and therapists. The working alliance has been known to predict the outcome of psychotherapy and is often considered an important common factor. This study raised the question of how to conceptualize the working alliance in the blended format.MethodsThis was an exploratory study derived from a randomized controlled trial comparing bCBT and face-to-face cognitive behavioural therapy (ftf CBT) on depression. The change in depressive symptoms was measured with the Patient Health Questionnaire (PHQ-9) and the working alliance was measured using the Working Alliance Inventory.AnalysesCorrelation coefficients were calculated for the working alliance as reported by clients and therapists, working alliance was then examined at item and dimension level (task, bond, goal). Linear regression models were applied to investigate the predictive value of the working alliance on treatment outcome. Interaction between the level of working alliance and treatment condition was also considered.ResultsClient and therapist working alliance ratings correlated at r = 0.44 and clients rated the working alliance higher than therapists (x̄ clients = 48.6, x̄ therapists = 44.6). ftf CBT and bCBT had comparable joint working alliance ratings (x̄ ftf = 46.4, x̄ bCBT = 46.8). Items had little deviation apart from item 4 with high positive values. The level of working alliance from the total sample did not significantly predict outcome based on the client's perspective. Contrarily, seen from the therapist's perspective, it did (b = 0.00, p = .044). Using the mean from these predictors as a composite variable, was also significant (b = 0.00, p = .039, R2 adj = 0.07). There was no significant interaction with treatment condition.DiscussionClients and therapists may lay emphasis on different aspects of the working alliance. The finding that therapist-rated working alliance was better than client working alliance at predicting outcome went against common findings; this pattern may be specific to bCBT.ConclusionClients rated the working alliance slightly higher than therapists on average. Clients and therapists as well as treatment conditions had different profiles on dimension deviations. Therapist ratings of the working alliance appeared to better predict treatment outcome than client ratings. Joint working alliance predicted outcome using client and therapist composite means. The working alliance was equally strong in ftf CBT and bCBT. The absence of interaction with treatment condition indicated that the working alliance was equally predictive of outcome in ftf CBT as in bCBT.

Project description:ImportancePostpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women.ObjectiveTo test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months.Design, setting, and participantsA 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016.InterventionsClinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics.Main outcomes and measuresThe primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet.ResultsParticipants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P < .001; difference, 2.3 kg (95% CI, 1.1 to 3.5). More participants in the intervention group than the standard care group returned to preconception weight by 12 months (32.8% in the intervention group vs 18.6% in the standard care group, P < .001; difference, 14.2 percentage points [95% CI, 4.7 to 23.5]). The intervention group and standard care group did not significantly differ in 12-month changes in physical activity (mean [95% CI]: -7.8 min/d [-16.1 to 0.4] in the intervention group vs -7.2 min/d [-14.6 to 0.3] in the standard care group; difference, -0.7 min/d [95% CI, -42.0 to 10.6], P = .76), calorie intake (mean [95% CI]: -298 kcal/d [-423 to -174] in the intervention group vs -144 kcal/d [-257 to -32] in the standard care group; difference, -154 kcal/d [-325 to 17], P = .06), or incidences of injury (16 in the intervention group vs 16 in the standard care group) or low breastmilk supply from baseline to month 6 (21 of 61 participants in the intervention group vs 23 of 72 participants in the standard care group) and from month 6 to 12 (13 of 32 participants in the intervention group vs 14 of 37 participants in the standard care group).Conclusions and relevanceAmong low-income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to determine program and cost-effectiveness as part of the WIC program.Trial registrationclinicaltrials.gov Identifier: NCT01408147.

Project description:ObjectivesThe objectives of this study were to determine whether a technology-enhanced weight-loss program, using a home pet health technology ecosystem, is an effective tool in feline weight-loss management in multiple-cat households and to evaluate its impact on cat behavior.MethodsThe study was a prospective parallel unmasked block-randomized controlled trial comparing two weight loss intervention groups: (1) traditional group with dietary restriction alone (n = 9); (2) technology group that used dietary restriction, digital scales, smart feeders, activity monitors and pet treat cameras (n = 6). A 12-week weight-loss program of client-owned indoor-only two- or three-cat households with at least one overweight cat was conducted in Canada and the USA. Owner impressions of the technology, weight loss rates, smart feeder data, activity monitor data and health-related quality of life (HRQoL) were assessed.ResultsThe study was completed by 9/15 traditional group and 6/10 technology group cats. Dropouts were mainly due to owner issues unrelated to the study. The pet health technology ecosystem received favorable reviews (six responders). Smart feeders and home scales were perceived as valuable additions, while activity monitors and pet treat cameras were valued lower. The average weekly weight-loss rate (percent loss of initial body weight) was higher (P = 0.036) in the technology group (0.694%) than in the traditional group (0.175%). Although not associated with weight-loss rates, technology group cats trended toward grazing feeding patterns and decreased daily activity counts, while HRQoL increased, on average, for all cats.Conclusions and relevanceThis introductory investigation suggests that a technology-enhanced weight-loss program would be accepted by cat owners and may deliver advantageous outcomes in multiple-cat households, providing an effective and practical tool in feline weight-loss strategies that will continue to evolve as new technologies become available. It also illustrates the potential value of data gathered from home monitoring devices and digital diaries, providing deeper insights into pet behavior.

Dataset Information

Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial.

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Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial.

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