Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Web-based Lifestyle Coaching Program in Denmark: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Jeanette Reffstrup Christensen ◽  
Camilla Sortsø ◽  
Jørgen T Lauridsen ◽  
Pernille R Jakobsen ◽  
Ditte H Laursen ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Body Composition ◽  
Body Weight ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
And Control

BACKGROUND Lifestyle interventions can delay and reverse the onset of type 2 diabetes (T2D) and decrease morbidity and mortality. Studies suggest that digital coaching based on real-time monitoring can lead to clinically relevant weight loss, as well as decreased or normalized hemoglobin A1c (HbA1c) for a significant number of patients. OBJECTIVE To assess whether an eHealth lifestyle coaching program (LIVA 2.0) for patients with T2D who are motivated for lifestyle changes leads to significant weight loss and decreased HbA1c, compared to usual care. METHODS In a randomized controlled single-blinded trial, 170 patients with T2D were enrolled from March 2018 to March 2019 and randomized to the intervention (100) and control (70) groups. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The intervention comprised an initial face-to-face motivational interview followed by digital coaching. The same healthcare professional coach provided synchronous and asynchronous multimodal feedback and used digital behavioral change techniques enabled by an app providing live monitoring of lifestyle behaviors. Primary outcome was body weight. Secondary outcomes were changes in HbA1c, body composition, lipids, and quality of life at 6 months. RESULTS At 6 months, 75 patients (75%) in the intervention group and 53 patients (76%) in the control group remained in the study. Mean body weight loss was 4.2 kg (95% CI, 5.5- 3.0) in the intervention group vs 1.5 kg (95% CI, 2.57- 0.48) in the control group (P = .005). In the intervention group, 36 (52%) patients lost > 3% body weight, compared to 12 (32%) patients in the control group. Mean HbA1c was lower in both groups at 6 months, with reductions of 8.2% (95% CI, 11.01 to 5.29) and 5.5% (95% CI, 8.75 to 2.76) for the intervention and control groups, respectively (P = .203). In the intervention group, 24 (32%) had an HbA1c <6.5% at 6 months, compared to 8 (15%) in the control group (P = .03). CONCLUSIONS Reduction in body weight and remission rate for HbA1c, as well as improved body composition can be enhanced by using digital lifestyle coaching for patients with T2D. CLINICALTRIAL Trial Registration: Clinicaltrials.gov NCT03788915 https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR2-10.2196/19172 INTERNATIONAL REGISTERED REPORT RR2-10.2196/19172

Comparison of Sleeve Gastrectomy and Conservatory Treatment Effect on Biochemical and Hormonal Profile of Obese Type 2 Diabetes Subjects: CREDOR Randomized Controlled Study Results

2017 ◽  
Vol 68 (7) ◽  
pp. 1622-1627 ◽  
Author(s):  
Diana Simona Stefan ◽  
Andrada Mihai ◽  
Daiana Bajko ◽  
Daniela Lixandru ◽  
Laura Petcu ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Weight Loss ◽  
Sleeve Gastrectomy ◽  
Beta Cell ◽  
Beta Cell Dysfunction ◽  
Control Group ◽  
Cell Dysfunction ◽  
Randomized Controlled

Metabolic surgery is the most efficacious method for the treatment of morbid obesity and was recently included among the antidiabetes treatments recommended in obese type 2 diabetes (T2D) patients. The aim of this study was to compare in a randomized controlled trial the effect of sleeve gastrectomy (SG) to that of intensive lifestyle intervention plus pharmacologic treatment on some markers of insulin resistance and beta cell function as well as some appetite controlling hormones in a group of male obese T2D subjects. The study groups comprised 20 subjects for SG and 21 control subjects. Fasting blood glucose, insulin, proinsulin, adiponectin, leptin, ghrelin, HOMA-IR, HOMA-%B, proinsulin-to-insulin ratio and proinsulin-to-adiponectin ratio were evaluated at baseline and after one year follow-up. Overall, patients in the SG group lost 78.98% of excess weight loss (%EWL) in comparison with 9.45% in the control group. This was accompanied by a significant improvement of insulin resistance markers, including increase of adiponectin and decrease of HOMA-IR, while no changes were recorded in the control group. Weight loss was also associated with a significant improvement of proinsulin-to-insulin and proinsulin-to-adiponectin ratio, both surrogate markers of beta cell dysfunction. These also improved in the control group, but were only marginally significant. Our findings suggest that improved insulin resistance and decreased beta cell dysfunction after sleeve gastrectomy might explain diabetes remission associated with metabolic surgery.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 204
Author(s):  
Anissa Aharaz ◽  
Jens Henning Rasmussen ◽  
Helle Bach Ølgaard McNulty ◽  
Arne Cyron ◽  
Pia Keinicke Fabricius ◽  
...  
Keyword(s):  
Pilot Study ◽  
Controlled Trial ◽  
Inappropriate Medication ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Interviews ◽  
Number Of Patients ◽  
Multimorbid Patients ◽  
And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

scholarly journals Comparison of the Effectiveness of Lifestyle Modification with Other Treatments on the Incidence of Type 2 Diabetes in People at High Risk: A Network Meta-Analysis

Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1373 ◽  
Author(s):  
Kazue Yamaoka ◽  
Asuka Nemoto ◽  
Toshiro Tango
Keyword(s):  
Type 2 Diabetes ◽  
High Risk ◽  
Lifestyle Modification ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Lifestyle Modifications ◽  
Randomized Controlled ◽  
Indirect Comparisons

Background: Many clinical trials have been conducted to verify the effects of interventions for prevention of type 2 diabetes (T2D) using different treatments and outcomes. The aim of this study was to compare the effectiveness of lifestyle modifications (LM) with other treatments in persons at high risk of T2D by a network meta-analysis (NMA). Methods: Searches were performed of PUBMED up to January 2018 to identify randomized controlled trials. The odds ratio (OR) with onset of T2D at 1 year in the intervention group (LM, dietary, exercise, or medication) versus a control group (standard treatments or placebo) were the effect sizes. Frequentist and Bayesian NMAs were conducted. Results: Forty-seven interventions and 12 treatments (20,113 participants) were used for the analyses. The OR in the LM was approximately 0.46 (95% CI: 0.33 to 0.61) times lower compared to the standard intervention by the Bayesian approach. The effects of LM compared to other treatments by indirect comparisons were not significant. Conclusions: This meta-analysis further strengthened the evidence that LM reduces the onset of T2D compared to standard and placebo interventions and appears to be at least as effective as nine other treatments in preventing T2D.

scholarly journals Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes: results of a randomized controlled trial (TRIGGER study)

2019 ◽  
Vol 7 (1) ◽  
pp. e000981 ◽  
Author(s):  
Anne Meike Boels ◽  
Rimke C Vos ◽  
Lioe-Ting Dijkhorst-Oei ◽  
Guy E H M Rutten
Keyword(s):  
Type 2 Diabetes ◽  
Dietary Habits ◽  
Management Education ◽  
Intervention Group ◽  
Self Management ◽  
Smartphone App ◽  
Control Group ◽  
Hypoglycemic Event ◽  
Randomized Controlled

ObjectiveTo investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methodsOpen two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.ResultsSixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference −0.93 mmol/mol (−0.08%), 95% CI −4.02 to 2.17 mmol/mol (−0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.ConclusionsThis smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them.Trial registration numberNTR5515.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

scholarly journals The Effect of Diabetes Self-Management Education on Body Weight, Glycemic Control, and Other Metabolic Markers in Patients with Type 2 Diabetes Mellitus

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Chuang Yuan ◽  
Christopher W. K. Lai ◽  
Lawrence W. C. Chan ◽  
Meyrick Chow ◽  
Helen K. W. Law ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Body Weight ◽  
Management Education ◽  
Intervention Group ◽  
Intima Media Thickness ◽  
Self Management ◽  
Control Group ◽  
Metabolic Markers

Aims.To comprehensively evaluate the effect of a short-term diabetes self-management education (DSME) on metabolic markers and atherosclerotic parameters in patients with type 2 diabetes.Methods.76 patients with type 2 diabetes were recruited in this study. They were divided into the intervention group(n=36)and control group(n=40). The patients in the intervention group received a 3-month intervention, including an 8-week education on self-management of diabetes mellitus and subsequent 4 weeks of practice of the self-management guidelines. The patients in the control group received standard advice on medical nutrition therapy. Metabolic markers, carotid intima-media thickness (CIMT), and carotid arterial stiffness (CAS) of the patients in both groups were assessed before and after the 3-month intervention.Results.There was a significant reduction in hemoglobin A1c (HbA1c,-0.2±0.56% versus0.08±0.741%;P<0.05) and body weight (-1.19±1.39 kg versus-0.61±2.04 kg;P<0.05) in the intervention group as compared to the control group. However, no significant improvements were found in other metabolic markers, CIMT and CAS(P>0.05).Conclusions.DSME can improve HbA1c and body weight in patients with type 2 diabetes.

scholarly journals A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Caloric Intake ◽  
First Trimester ◽  
Control Group ◽  
Optimal Weight ◽  
Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

scholarly journals Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

2020 ◽  
Vol 8 (1) ◽  
pp. e001030 ◽  
Author(s):  
Qinglin Lou ◽  
Qing Ye ◽  
Haidi Wu ◽  
Zhiyong Wang ◽  
Robert S Ware ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Large Scale ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mainland China ◽  
Outcome Variable ◽  
Control Group ◽  
Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; <i>P</i>&lt;.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; <i>P</i>&lt;.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; <i>P</i>&gt;.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

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