Multicomponent Lifestyle Intervention Research Articles

Effects of a multicomponent lifestyle modification intervention on liver function, lipid profile, and body composition in adults with elevated hepatic steatosis index

Parallel to the escalating burden of obesity is the steadily increasing prevalence of metabolic dysfunction associated steatotic liver diseases (MASLD), a chronic condition that progresses from simple steatosis to advanced stages of steatohepatitis, fibrosis, and cirrhosis (1-2). MASLD, regarded as the hepatic manifestation of metabolic syndrome is known to be exacerbated by unhealthy lifestyle choices and the presence of comorbidities such as diabetes, dyslipidemia, and obesity (3-4). Therefore, early identification of the general population at risk of MASLD and the development of multicomponent interventions that can prevent the progression of liver damage and mitigate associated adverse cardiometabolic health outcomes are important. Our study aimed to evaluate the effects of a lifestyle modification program on glucose levels, lipid profile, liver function, and body composition measures in community-living adults with elevated hepatic steatosis index in Mumbai, India.Adults (n= 231, mean age 46.1(13.7) years), 58.6% men) were screened for risk of MASLD using a non-invasive screening tool, Hepatic Steatosis Index (HSI) (calculated as (HSI)= 8 x (ALT/AST ratio) +BMI (+2, if female; +2, if diabetes mellitus) (5). Eligible participants with HSI >36 (predictive of the presence of MASLD) were randomized to receive either a multicomponent lifestyle intervention (experimental group, EG) comprising weekly sessions of individualized dietary counseling (Participants having BMI >23kg/m2 (n = 36) received hypocaloric diets with 40% carbohydrates, 40% fat and 30% proteins (WLD) and those having BMI <22.9kg/m2 (n= 22) received weight maintenance diet (WMD) plans including 55% carbohydrates, 15% protein and 30% fats) and fortnightly group sessions of structured exercise and nutrition education or a standard of care package (control group, CG, n= 43) including general healthy eating and activity guidelines for the 8- week study duration. Paired t test and independent sample t tests were used to determine within and between group changes in variables from baseline to endline.Trial Registration: This study is registered as CTRI/2022/05/042927.Overall, the prevalence of MASLD was 52.2%, 32.8% were hypertensive, and 26.7% and 15.4% had diabetes and hypertriglyceridemia respectively. The intervention (WLD) resulted in decreased weight (mean (M)= 3.4 kg, standard error (SE) = 1.88 k, p = 0.02), body fat percent (M = 2.2%, SE = 1.1%, p= 0.042), serum triglycerides (M=28.8mg/dL, SE 8.5mg/dL, p<0.001) and AST (M= 3.8 U/L, SE= 2.2U/L, p <0.05) values. The WMD group reported improvements in serum cholesterol levels, and ALT/ AST ratio as compared to CG (p <0.001). In WMD, HDL-C increased from 45.8 mg/dl to 47.2 mg/dl and the mean AST values reduced from 28.8 (10.6) U/L to 25.6 (9.9) U/L, but these changes were not statistically significant.Multicomponent lifestyle modification programs integrating diet, physical activity and education are effective strategies to improve liver outcomes and optimize cardiometabolic health in people with MASLD.

Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol

BackgroundMidlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults. Methods and study designThe Food Resources and Kitchen Skills plus Aerobic Training (FoRKS+) study is a 2-arm, single-blinded trial that compares those receiving the FoRKS+ program (target N = 64) versus those receiving enhanced usual care (target N = 64) in local federally-qualified health centers. Key eligibility criteria include self-identified NHB adults between ages 35–75 with a mean systolic blood pressure ≥ 130 mm/Hg obtained from 24-h ambulatory blood pressure monitoring. The FoRKS+ program includes 5 weeks of hypertension self-management courses, 11 weeks of nutrition courses, and 12 weeks of aerobic training in dietitian and health coach-led virtual groups. We will collect data on primary cognitive outcomes, feasibility, hypothesized intervention mediators and moderators, and demographic and health covariates at baseline, near intervention weeks 16-, and 28 (primary outcome assessment), and week 52 follow-up. We will use mixed-effects modeling to examine intervention effects on cognition. DiscussionThis pilot RCT will examine the feasibility and preliminary effects of a multicomponent lifestyle intervention on cognitive function in NHB adults, which may have implications for reducing health disparities in ADRD.

Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study

IntroductionBreast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and...

Participation in a multicomponent lifestyle intervention for people with obesity improves glycated hemoglobin (HbA1c).

Obesity is associated with compromised glucose metabolism. Hence, it is of interest to investigate if the lifestyle interventions used in the LIBRA-cohort, which aimed at not only weight loss, but also patient well-being, could also help obese patients improve glucose metabolism by evidence of reduced HbA1c. The aim of the study was to retrospectively investigate if patients who were referred to a lifestyle intervention for obesity, were able to alter HbA1c. Patients with a BMI≥30 undergoing a 6-month lifestyle intervention, who also completed physical and mental health surveys and whose baseline and 6-month blood samples were available, were included in the analysis. For changes in HbA1c and body weight a clinically relevant change of 5≥mmom/mol and 5%≥, respectively, was chosen. Participants were divided into groups according to their baseline HbA1c level: "Diabetes": HbA1c of ≥6.5% (≥48 mmol/mol), "Prediabetes": HbA1c of 5.7% to 6.4% (39-47.99 mmol/mol) or "Normal" HbA1c <5.7% (<39 mmol/mol). 180 patients met the stated inclusion criteria and these patients were divided into groups (median age (25th;75th quartile): Diabetes: n=47, age 54 (43;60), 51% women, Prediabetes: n=68, age 60 (50;66), 71% women and Normal: n=65, median age 61 (50;66), 85% women. Significant reductions were found in all three groups and specifically in the diabetes group HbA1c was reduced (mean [95%CI]) -5[-8;-2] mmol/mol from baseline to the end of the intervention. Furthermore, 35% of patients with prediabetes normalized their HbA1c (<39) and 30% patients with diabetes reduced their HbA1c <48. All groups had clinically relevant (≥5%) reductions in body weight (p<0.01). There was an association between body weight reduction and HbA1c reduction in the diabetes group (p<0.01). All groups reported improvements in physical health (p<0.01). In this retrospective cohort study, all patients achieved clinically relevant weight loss after participation in the lifestyle intervention and obese patients with diabetes achieved clinically relevant reductions in HbA1c after 6-months. More than 1/3 of patients with prediabetes normalized their HbA1c.

Effectiveness of a multicomponent lifestyle intervention against cognitive decline and dementia in an at‐risk‐population in Germany – Preliminary results of the cluster‐randomized AgeWell.de‐trial

AbstractBackgroundMounting evidence suggests that dementia can be prevented. Targeting several risk factors simultaneously constitutes a promising strategy for preserving cognitive function. The AgeWell.de‐study was a cluster‐randomized trial applying a multi‐domain intervention to preserve cognitive function in older adults at risk for dementia in Germany.MethodIndividuals with a Cardiovascular Risk Factors, Aging and Dementia (CAIDE) dementia risk score ≥ 9 points aged 60‐77 years were recruited. According to randomization of their general practitioner (GP) practice, patients received either a multi‐domain intervention (optimization of nutrition and medication, physical, social and cognitive activity, cardiovascular risk management, intervention in case of depressive symptoms and/or grief) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance, assessed using a composite score based on z‐scores of domain‐specific neuropsychological tests.ResultOf 1,030 participants at baseline (intervention/control: n = 487/543), n = 819 (intervention/control: n = 378/441) completed the follow‐up assessment. Intervention and control group did not differ regarding global cognitive performance (β = 0·010, 95% CI: ‐0·085; 0·105) at follow‐up. However, post‐hoc analyses revealed beneficial effects for social cognition (β = 0·132, 95% CI: 0·012; 0·252) and health‐related quality of life (β = 0·194, 95% CI: 0·065; 0·323). The intervention improved global cognitive performance (β = 0·221, 95% CI: 0·015; 0·428), social cognition (β = 0·259, 95% CI: 0·024; 0·494) and health‐related quality of life (β = 0·421; 95% CI: 0·114; 0·728) in participants with low education, and reduced depressive symptoms in highly educated participants (β = ‐0·431; 95% CI: ‐0·781; ‐0·082). Younger participants benefitted from the intervention regarding social cognition (β = 0·174, 95% CI: 0·010; 0·337) and health‐related quality of life (β = 0·405, 95% CI: 0·241; 0·570).ConclusionNo effect of the multi‐domain intervention on global cognitive performance was found for the overall sample. The intervention benefitted global cognitive functioning in individuals with low education and social cognition and health‐related quality of life across the sample. Further benefits regarding specific subgroups point towards the usefulness of tailored interventions.

Public mental health and wellbeing interventions delivered by allied health professionals (AHPs): mapping the evidence and identification of gaps. A systematic review

PurposeMental well-being is associated with positive outcomes throughout the life course. This study aims to examine interventions delivered by allied health professionals (AHPs) to alleviate community stressors adversely impacting public mental health and well-being.Design/methodology/approachReview inclusion criteria comprised experimental and qualitative process evaluations of public mental health interventions delivered by AHPs. Electronic searches in Cinahl, Embase, Medline, PsycINFO and the Cochrane Library, were combined with grey literature searches of National Institute for Health and Care Excellence public health guidance. A narrative synthesis and the Effective Public Health Practice Project appraisal tool were used to evaluate the evidence.FindingsA total of 45-articles were included in the review describing AHP-delivered interventions addressing social disadvantage, trauma, bullying, loneliness, work-related stress, transitional stress, intersectionality, pain and bereavement. No articles were identified evaluating interventions delivered by operating department practitioners or orthoptists. A conceptual map was developed summarising the stressors, and a typology of public mental health interventions defined including: place-based interventions, discrete/one-off interventions, multi-component lifestyle and social connector interventions and interventions targeting groups at risk of mental health conditions.Research limitations/implicationsMany mental health conditions begin in childhood, and a strength of the review is the life course perspective. A further strength is compiling a compendium of public mental health outcome measures used by AHPs to inform future research. The authors excluded many articles focussed on clinical interventions/populations, which did not meet review inclusion criteria. While playing a key role in delivering public mental health interventions, clinical psychologists are not defined as AHPs and were excluded from the review, and this may be construed a limitation. Given heterogeneity of study designs and interventions evaluated numerical analyses of pooled findings was not appropriate.Practical implicationsThe review highlights the breadth of community stressors on which AHPs can intervene and contribute in public mental health contexts, stressors which correspond to those identified in UK Government guidance as currently important and relevant to address. The findings can inform developing community public mental health pathways that align with the UK National Health Service (NHS) Long Term Plan, on prevention and early intervention to protect community mental health and well-being. Further can inform the NHS strategic direction for AHPs including informing ways of increasing utilisation of core AHP skills to optimise contributions in public mental health agendas.Social implicationsIt is surprising there were not more AHP delivered evaluations of interventions for other stressors important to address in public mental health settings, for example gambling, domestic violence or that used digital technology, and these are areas for future research. Future research should identify the most active/effective dimensions of multi-component interventions which could be informed by frameworks to guide complex intervention development. The relative paucity of research identified, highlights the predominant focus of research to date on interventions for clinical mental health conditions and populations. The lack of preventative approaches is evident, and an important area for future research to align with UK health and social care priorities.Originality/valueThe review highlights AHP-delivered interventions impacting diverse community stressors across the life course. The findings can inform developing public mental health pathways aligned with government health service priorities to protect mental health and well-being, prioritise prevention and early intervention and increase utilisation of AHP skills across public mental health settings.

Efficacy and safety of liraglutide for weight management in children and adolescents: a systematic review and meta-analysis of randomized controlled trials.

Liraglutide is safe and effective in weight-reducing and glycemic control in children and adolescents. • A few first-line treatment of these children and adolescents with overweight and obesity is a multi-component lifestyle intervention. • Lifestyle modifications are not suitable for all individuals, therefore, new treatment strategies urgent need to be established. • This is the first meta-analysis conducted to assess the efficacy and safety of liraglutide for weight management in children and adolescents. • Liraglutide is safe and effective in weight-reducing and glycemic control in children and adolescents.

Evidence Base Update on Behavioral Treatments for Overweight and Obesity in Children and Adolescents

ABSTRACT Objective This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents. Method Articles were identified through a systematic search of the biomedical literature in PubMed/MEDLINE (1946-), Elsevier EMBASE (1947-), SCOPUS (1823-), Clarivate Web of Science Core Collection (WOS, 1900-), PsycINFO (1800-), The Cochrane Library and Clinicaltrials.gov published between June 2014 and August 2022. Results Family-based treatment (FBT) remains a well-established treatment for overweight and obesity in children and is now well-established in adolescents and toddlers. Parent-only behavioral treatment remains well-established in children and is now well-established among adolescents and children. Possibly effective treatments continue to include FBT-parent only for adolescents, and behavioral weight loss (BWL) with a family component for adolescents, children, and toddlers. Several variations of FBT and BWL can now be considered possibly effective including FBT+motivational interviewing, FBT+social facilitation maintenance, group-based FBT, low-dose FBT, BWL+stress management, and camp-based BWL. Cognitive behavioral treatment (CBT) for adolescents also met criteria for possibly effective treatments. Current research has also established that behavioral treatments can be effectively delivered in alternative settings (e.g. primary care) and through alternative mediums (e.g. telehealth). Conclusions Research continues to support the use of multicomponent lifestyle interventions in accordance with recent recommendations from the American Academy of Pediatrics, the American Psychological Association, and the United State Preventative Services Task Force. However, more work is needed to ensure appropriate access for children with comorbid medical and psychiatric disorders and children from socially, politically, and economically marginalized groups.

Preliminary Findings of an Active Multicomponent Lifestyle Intervention for People with Dementia and Their Carers: Mixed Methods Study

There is a need for integrated and effective postdiagnostic rehabilitation programs for community-dwelling people with dementia and their carers to promote their quality of life and management of dementia. Here, we report on preliminary findings of the Sustainable Personalised Interventions for Cognition, Care, and Engagement (SPICE) Program conducted in Canberra, Australia. Over twelve weeks, six people with dementia and their carers completed five hours of weekly small group activities and separate individual appointments. SPICE is an active therapeutic intervention with five components delivered by allied health professionals: (1) cognitive stimulation therapy; (2) carer education, support, and capacity building; (3) physical activity; (4) Care Of People with dementia in their Environments (COPE) program; and (5) dietary assessment and advice. Participants completed questionnaires pre- and post-intervention and a program evaluation interview which was analysed by qualitative thematic analysis. The program demonstrated high program satisfaction ratings and program adherence (94% people with dementia and 92% carers) which supports intervention feasibility. The results of quantitative outcome measures suggest positive effects, but inferences cannot be drawn due to small sample size. Qualitative themes from participant experiences highlighted the following: (1) social connection, engagement, and interaction were key drivers of the success of the program; (2) clinicians fostered a positive and respectful culture; (3) carers were supported with strategies and skills to reframe dementia; and (4) reablement can be fun. The new combination of evidence-based interventions was feasible and considered valuable. Further results are required to confirm these findings and support a longer-term trial.

Cost-effectiveness analysis of physical activity interventions for people with schizophrenia or bipolar disorder: systematic review.

Clinical guidelines recommend providing physical activity interventions (PAIs) to people with schizophrenia or bipolar disorder for weight management. However, the cost-effectiveness of PAIs is unknown. To evaluate the availability and methodological quality of economic evaluations of PAIs for people with schizophrenia or bipolar disorder. Four databases (MEDLINE, Embase, PsycInfo and Scopus) were searched on 5 July 2022. Based on the retrieved studies, forward and backward citation searches were conducted. Two reviewers independently selected studies for inclusion. Study quality was assessed using the Drummond checklist. Review results were presented using narrative synthesis. Fourteen articles reporting nine studies were included. All included studies assessed PAIs within a multicomponent lifestyle intervention. Mixed findings were reported on the cost-effectiveness of multicomponent lifestyle intervention: three studies reported it as cost-effective; four studies reported it as not cost-effective; and two studies did not conclude whether it was cost-effective or not. Very limited evidence suggests that certain patient subgroups might be more likely to benefit from multicomponent lifestyle interventions with a PAI component: men; individuals with comorbid type 2 diabetes; and individuals who have been psychiatric hospital in-patients for ≥1 year. The quality of included studies ranged from moderate to high. The current economic evidence suggests that not all modalities of multicomponent lifestyle intervention including a PAI component are cost-effective for people with schizophrenia or bipolar disorder; and not all people with schizophrenia or bipolar disorder would benefit equally from the intervention. Future research is urgently needed to identify the cost-effective modality of PAI for different patient subgroups.

The outcome of a multicomponent lifestyle intervention in patients with obesity: A cohort study

Persons with obesity are at risk of developing diseases. Furthermore, people with obesity are often stigmatized and struggle with how to improve their lifestyle despite perhaps already knowing what healthy habits consist of. Hence, there is a need for lifestyle interventions aimed at improving mental well-being in patients with obesity in order to induce lifestyle change. The aim of the study was to investigate the outcome of a multicomponent lifestyle intervention in a group of Danish patients with obesity (Body Mass Index (BMI) ≥30). The study was a cohort study for patients referred for a multicomponent lifestyle intervention (3 times/6 months) at a lifestyle rehabilitation center from 2016 to 2019 with a BMI ≥30. Patients completed questionnaires at baseline, 6 and 18 months regarding diet, physical activity, body weight, the Short-Form 12-Item Health Survey (SF-12) (minimal important change ≥5 points) and a question regarding satisfaction with treatment. A total of 1336 patients (mean age (standard deviation) 51(14) years, 25% men) were included. Median weight change (25th;75th quartile) was -5% (-2;-8%), p<0.001 from baseline to 6 months and -4% (0;-9%), p<0.001 at 18 months. After the intervention, only 8% patients had an unhealthy diet and patients reported increased participation in physical activities (+1 day/week) (p<0.001). Patients changed their mean [95%confidence interval] SF-12 physical score 4.0 [3.4;4.5] points (p<0.001) at 6 months follow up and 3.2 [2.4;3.8] points (p<0.001) at 18 months. Their SF-12 mental scores were changed 2.8 [2.2;3.4] points (p<0.001) at 6 months and 2.3 [1.5;3.1] points (p<0.001) at 18 months. 40–45% patients had a minimal important change in their SF-12 scores. 91% of the patients were highly satisfied with the treatment. Patients participating in a multicomponent lifestyle intervention focusing on improving mental factors had improved outcomes at 6 and 18 months follow up.

Treating and Managing Urinary Incontinence: Evolving and Potential Multicomponent Medical and Lifestyle Interventions.

Incontinence is defined by either ICS 2002 or IUGA/ICS 2010 as the involuntary loss of urine and includes urgency urinary incontinence (UUI), stress urinary incontinence (SUI) or mixed urinary incontinence (MUI). It has a high worldwide prevalence with an associated impact on quality of life. Despite existing management options for the management of urinary incontinence, patients continue to be troubled by symptoms or side effects of existing treatment. There is therefore a requirement for ongoing research into treatment options for the management of UUI and SUI, that are more effective and tolerable to patients. Advances in treatment of UUI include a more selective beta 3 agonist, Vibegron, which has less impact on cardiac function than Mirabegron. Hormonal treatment, including Ospemifene and Prasterone, may improve GSM and in turn symptoms of UUI. There are advances in the types of neuromodulators available, including those that are rechargeable at home and are MRI safe. Laser has shown promising initial results. There is developing interest in the microbiome, and how this may impact future treatment modalities. Advances in treatment of SUI include the use of mobile health applications to support delivery of pelvic floor muscle training. Litoxetine, a selective serotonin reuptake inhibitor, has shown promising results at phase III trials. Functional magnetic stimulation is being developed to improve contractility of pelvic floor muscles. We also discuss interventions that improve tissue elasticity and regeneration, such as platelet rich plasma, autologous stem cell transplantation, laser therapy and radiofrequency treatment, which show short term benefits.

Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention.

Women with polycystic ovary syndrome (PCOS) and excess weight often present with reproductive derangements. The first-line treatment for this population is a multi-component lifestyle intervention. This follow-up study of a randomized controlled trial based on data from the Dutch Perinatal registry was conducted to study the effect of a one-year three-component (cognitive behavioral therapy, healthy diet, and exercise) lifestyle intervention on pregnancy outcomes in women with PCOS and overweight or obesity. Women diagnosed with PCOS, a BMI ≥ 25 kg/m², and a wish to conceive were randomized to either three-component lifestyle intervention (LSI, n = 123), and care as usual (CAU, n = 60) where they were encouraged to lose weight autonomously. Conception resulting in live birth was 39.8% (49/123) within LSI and 38.3% (23/60) within CAU (p = 0.845). In total, 58.3% conceived spontaneously. Gestational diabetes (LSI: 8.2% vs. CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs. CAU 13.0%, p = 0.673), and preterm birth (LSI: 12.2% vs. CAU: 17.4%, p = 0.716) rates were all lower in LSI compared to CAU. This follow-up study showed no significant differences in conception resulting in live birth rates between LSI and CAU. Nonetheless, a large proportion eventually conceived spontaneously. Moreover, after LSI, the number of uneventful pregnancies was lower compared to care as usual.

Obesity in infancy: new precision treatment

Obesity is a chronical disease, which leads to multiple short- and long-term complications. 4% of Swiss children and adolescents are obese. A prompt diagnosis and multicomponent lifestyle intervention is mandatory to avoid persistence of the disease into adulthood. Growth and BMI charts are still the essential tools to diagnose and define the etiology of obesity. A precocious and severe obesity, accompanied by hyperphagia, will raise the suspicion of monogenic obesity. The precise molecular diagnosis enables in some patients the use of a specific treatment. Leptine in case of LEP gene defects, or setmelanotide when the affected gene is part of the MC4R signaling pathway (LEPR, POMC, PCSK1).

Retrospective analysis on the effect of Reverse Diabetes2 Now on kidney function in patients with type 2 diabetes with impaired kidney function

ObjectiveType 2 diabetes is one of the main causes of kidney damage. Recent intervention studies suggest that the progression of type 2 diabetes can be halted, or even brought into...

The effectiveness of lifestyle interventions on type 2 diabetes and gestational diabetes incidence and cardiometabolic outcomes: A systematic review and meta-analysis of evidence from low- and middle-income countries.

SummaryBackgroundAs lifestyle modification offers a unique strategy to prevent diabetes, we evaluated the effectiveness of lifestyle interventions in the prevention of type 2 diabetes and gestational diabetes in low- and middle-income countries (LMICs).MethodsWe did a systematic literature review and meta-analysis. We searched MEDLINE, Embase, Web of Science, and Cochrane Library for randomised controlled trials published in English, Spanish, French, and Portuguese between 1 January 2000 and 15 June 2022, evaluating multi-target and multi-component lifestyle interventions in at-risk populations conducted in LMICs. The main outcomes were incidence of type 2 diabetes and gestational diabetes, and indicators of glycaemic control. We assessed the methodological quality of the studies using the Cochrane risk of bias tool. Inverse-variance random-effects meta-analyses estimated the overall effect sizes. Sources of heterogeneity and study bias were evaluated. The study protocol was registered in PROSPERO (CRD42021279174).FindingsFrom 14 330 abstracts, 48 (0·3%) studies with 50 interventions were eligible of which 56% were conducted in lower-middle-income countries, 44% in upper-middle, and none in low-income. 54% of the studies were assessed as moderate risk of bias and 14% as high risk. A median of 246 (IQR 137-511) individuals participated in the interventions with a median duration of 6 (3-12) months. Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of HbA1c by 0·15% [−0·25 to −0·05], fasting plasma glucose by 3·44 mg/dL [−4·72 to −2·17], and 2-hr glucose tolerance by 4·18 mg/dL [−7·35 to −1·02]. No publication bias was suggested for these outcomes. High levels of heterogeneity (I²≥ 81%) were found in most meta-analyses. Exploration using meta-regressions could not identify any explanatory variable, except for fasting glucose for which the quality score of the articles seems to be an effect modifier decreasing slightly the heterogeneity (72%) in the low risk of bias pooled estimate. The effect on gestational diabetes could not be evaluated due to the scarcity of available studies.InterpretationComprehensive lifestyle interventions are effective strategies to prevent type 2 diabetes among at-risk populations in LMICs. The heterogeneity identified in our results should be considered when using these interventions to address the onset of type 2 diabetes.FundingNone.

P-627 Pregnancy Rate and Outcomes Following a Randomized Controlled Three-component Lifestyle Intervention in Women with PCOS

Abstract Study question What is the impact of a three-component lifestyle intervention on the pregnancy rate, time to pregnancy and pregnancy complications in women with polycystic ovary syndrome? Summary answer A non-significant positive trend in pregnancy outcomes was demonstrated in favor of the lifestyle intervention groups, in line with the weight loss achieved per group. What is known already PCOS (polycystic ovary syndrome) is associated with overweight and obesity. Women with PCOS and overweight or obesity present with more pronounced reproductive derangements. Moreover, when pregnant, pregnancy complications such as gestational diabetes, hypertensive disorders and preterm birth seem to be more prevalent in this population. The first line treatment for women with PCOS and overweight or obesity is a multi-component lifestyle intervention. Data on pregnancy outcomes after multi-component lifestyle interventions in women with PCOS are scarce. Study design, size, duration The present study is a one-year randomized controlled trial to investigate the effect of a three-component (cognitive behavioral therapy, healthy diet and physical therapy) lifestyle intervention (LSI) with or without Short Message Service (SMS) on pregnancy leading to live birth, pregnancy complications and outcomes within 24 months after the start of the lifestyle intervention compared to care as usual (CAU). Participants/materials, setting, methods Women diagnosed with PCOS according to the Rotterdam 2003 criteria and a BMI above 25 kg/m² were included. A total of 183 participants were randomly assigned to three groups: 1) three-component lifestyle intervention with SMS (SMS+); 2) three-component lifestyle intervention without SMS (SMS-); 3) care as usual (CAU): encourage to lose weight autonomously (control group). Pregnancy and neonatal outcomes were collected from the Dutch Bureau of Statistics (CBS) combined with the Dutch Perinatal registry (Perined). Main results and the role of chance Within 24 months after the start of the intervention the pregnancy rate leading to live birth was 41.7% (25/60) within SMS+, 38.1% (24/63) within SMS- and 38.3% (23/60) within CAU. This was non-significant between the groups. Mean time to pregnancy for SMS+ was 18.3 months, 19.1 months for SMS- and 19.4 months for CAU (p = 0.775). Gestational diabetes (LSI: 8.2% vs CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs CAU: 13.0%, p = 0.673) and preterm birth (LSI: 12.2% vs CAU: 17.4%, p = 0.716) rates were all lower in the LSI groups (SMS+ and SMS- combined) compared to CAU. Limitations, reasons for caution Although significantly less than the LSI groups, even the CAU group achieved weight loss, which may give an underestimation of the effect of the lifestyle intervention with regard to pregnancy outcomes. Wider implications of the findings Weight loss overall seems to have a positive effect on pregnancy outcomes, and multi-component lifestyle interventions are needed to achieve weight loss. Trial registration number NTR2450

Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review.

BackgroundMobile health (mHealth) apps show vast potential in supporting patients and health care systems with the increasing prevalence and economic costs of noncommunicable diseases (NCDs) worldwide. However, despite the availability of evidence-based mHealth apps, a substantial proportion of users do not adhere to them as intended and may consequently not receive treatment. Therefore, understanding the factors that act as barriers to or facilitators of adherence is a fundamental concern in preventing intervention dropouts and increasing the effectiveness of digital health interventions.ObjectiveThis review aimed to help stakeholders develop more effective digital health interventions by identifying factors influencing the continued use of mHealth apps targeting NCDs. We further derived quantified adherence scores for various health domains to validate the qualitative findings and explore adherence benchmarks.MethodsA comprehensive systematic literature search (January 2007 to December 2020) was conducted on MEDLINE, Embase, Web of Science, Scopus, and ACM Digital Library. Data on intended use, actual use, and factors influencing adherence were extracted. Intervention-related and patient-related factors with a positive or negative influence on adherence are presented separately for the health domains of NCD self-management, mental health, substance use, nutrition, physical activity, weight loss, multicomponent lifestyle interventions, mindfulness, and other NCDs. Quantified adherence measures, calculated as the ratio between the estimated intended use and actual use, were derived for each study and compared with the qualitative findings.ResultsThe literature search yielded 2862 potentially relevant articles, of which 99 (3.46%) were included as part of the inclusion criteria. A total of 4 intervention-related factors indicated positive effects on adherence across all health domains: personalization or tailoring of the content of mHealth apps to the individual needs of the user, reminders in the form of individualized push notifications, user-friendly and technically stable app design, and personal support complementary to the digital intervention. Social and gamification features were also identified as drivers of app adherence across several health domains. A wide variety of patient-related factors such as user characteristics or recruitment channels further affects adherence. The derived adherence scores of the included mHealth apps averaged 56.0% (SD 24.4%).ConclusionsThis study contributes to the scarce scientific evidence on factors that positively or negatively influence adherence to mHealth apps and is the first to quantitatively compare adherence relative to the intended use of various health domains. As underlying studies mostly have a pilot character with short study durations, research on factors influencing adherence to mHealth apps is still limited. To facilitate future research on mHealth app adherence, researchers should clearly outline and justify the app’s intended use; report objective data on actual use relative to the intended use; and, ideally, provide long-term use and retention data.

The effect of lifestyle intervention on cardiometabolic risk factors in mental health rehabilitation hostel residents at-risk: a cluster-randomized controlled 15-month trial.

Cardiometabolic disorders contribute to morbidity and mortality in people with severe mental illnesses (SMI), yet lifestyle-intervention efficacy in patients with SMI is unclear. Israel's unique mental-health rehabilitation hostels (MHRHs) provide housing to subjects with SMI. We tested how multi-component lifestyle intervention affects cardiometabolic risk-factors in at-risk SMI populations residing in MHRHs. In a prospective, cluster-randomized, controlled study, six MHRHs, paired by residents' functioning level, were randomized to lifestyle intervention (nutrition education, physical education), or usual care. Subjects recruited included those with ≥1 of: BMI > 25 kg/m2; plasma triglycerides ≥150 mg/dL; HbA1c ≥ 5.7%; fasting plasma glucose ≥ 100 mg/dL and plasma HDL < 40(men)/ 50(women) mg/dL. Primary outcome was BMI change after 15 months; other outcomes were plasma lipids levels and glycemic control. Low cooperation in one MHRH pair led to their exclusion, the others were assigned to intervention or control. Eighty residents were enrolled to intervention groups and 74 to control. Compared to baseline, intervention-arm participants experienced improvements in BMI (-0.83 kg/m2 [-1.36, -0.29] 95%CI), triglycerides (-30.60 mg/dL [-49.39, -11.82]95%CI) and LDL (-15.51 mg/dL [-24.53, -6.50]95%CI) (all P ≤ 0.003). BMI improvement correlated with number of dietitian consultations (r = -0.30; P = 0.001). No significant differences were found between treatment arms in BMI (-0.46 kg/m2 [-1.11, 0.18]95%CI;P = 0.189), triglycerides (-24.70 mg/dL [-57.66, 8.25]95%CI), LDL (-9.24 mg/dL [-20.50, 2.03]95%CI), HDL and glycemic control. Lifestyle intervention significantly improved BMI, LDL and triglycerides compared to baseline in at-risk MHRHs residents with SMI, yet compared to usual care the differences did not reach statistical significance. The association between the number of dietitian's consultations and BMI improvement suggests that programs should highlight participants' adherence.

Effectiveness of multicomponent lifestyle intervention programs on adiposity indicators in schoolchildren from vulnerable groups: a review article.

Vulnerable groups are those who, due to their age, sex, race/ethnicity, health status, income level, etc., are at higher risk of poor health. Vulnerable school populations are distinguished by having predisposing factors to overweight and obesity, which results in a greater risk of suffering from the disease and its ravages. Additionally, the effects of the COVID-19 contingency can worsen the situation. Previous reviews of prevention, treatment and control of the disease have focused on schoolchildren from high- and middle-income countries. The objective of this review was to gather the evidence from the studies that evaluate the effectiveness of multicomponent lifestyle intervention programs (MLIP) on adiposity indicators in vulnerable populations. Five electronic databases were searched: PubMed, MEDLINE, Cochrane Library, EMBASE, and Google Scholar. The eligibility criteria were schoolchildren (5 to 12 years old), inhabitants of rural area, with low socioeconomic level and/or belonging to an indigenous community. Randomized and quasi-experimental controlled trials were included. Interventions that included two or more of the following components were considered: physical activity, nutrition, psychology, school meals and/or family/community involvement. Of the 11 interventions included 73 % had significant improvements in at least one variable related to adiposity. The most successful interventions had components of nutrition, physical activity and family/community involvement, the majority (80 %) had a duration of ≥ 6 months and were provided, in 80 % of the cases, by previously trained teachers. In conclusion, there is evidence that MLIPs are effective in improving indicators of adiposity in vulnerable schoolchildren.