Lifestyle Intervention Group Research Articles

Subjective memory complaints and the effect of a multidomain lifestyle intervention on cognition - the FINGER trial.

Older people reporting subjective memory complaints (SMCs) may have greater risk of cognitive decline. Multidomain lifestyle interventions are a promising strategy for the prevention of cognitive decline. The aim of this study was to investigate whether the presence of SMCs affects the efficacy of a 2-year multidomain lifestyle intervention on cognition. This study is part of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) project. Participants (a sub-sample of 568 individuals, baseline age 60 to 77 years) were randomized (1:1) to receive a 2-year multidomain lifestyle intervention group including dietary advice, exercise, cognitive training, and vascular risk management, or regular health advice control group. Cognitive performance was assessed at baseline and at 1- and 2-year visits, using a neuropsychological test battery, including tests assessing memory, executive functions, and processing speed. Participants rated the frequency of SMCs using the Prospective and Retrospective Memory Questionnaire. Having more retrospective SMCs was linked to a less favorable cognitive trajectory over 2 years. The difference between the intervention and control groups in annual change in tested memory performance was 0.077 (95 % CI 0.008-0.146) among those reporting more retrospective SMCs and -0.011 (-0.074-0.053) among those with less SMCs; interaction effect p=0.019. No other interactions between SMCs and intervention allocation were observed. A lifestyle intervention may be beneficial for older adults with and without SMCs. Persons having more retrospective SMCs may benefit more from the intervention regarding memory functioning.

Social networks as facilitators and barriers to behavior change among U.S. South Asian adult participants of a culturally adapted, group lifestyle intervention

ObjectivesThis qualitative study aimed to characterize how social networks influence cardiovascular health behaviors among U.S. South Asian adults in a culturally adapted, group lifestyle intervention. MethodsA purposive sample of participants (n = 24) from the South Asian Healthy Lifestyle Intervention (SAHELI) randomized trial’s intervention arm participated in semi-structured process evaluation interviews. Specific open-ended questions were used to probe participants’ behavior changes, personal social networks, and social support for behavior change. The team transcribed interviews and identified themes using inductive and deductive coding, based on a theoretical model of social influence. ResultsAmong 24 participants (67 % female, mean age 50.5 years, 88 % foreign-born, 50 % with limited English proficiency), three themes emerged: 1) SAHELI participants and their family members provided bidirectional social support for behavior change; 2) intervention participants provided social support to one another; and 3) participants faced resistance to change from some community members. ConclusionsBehavior changes initiated during SAHELI diffused to participants’ close family members. Several social network influences varied by participant gender, English language proficiency, and network member type. Practice ImplicationsHealth professionals should ask patients about how their social networks facilitate or hinder behavior changes. Gender and cultural factors may modify how social networks influence behavior change.

Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors

South Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population. To evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults. This single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion. A 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly. Primary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models. Among 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, -0.07 kg; 95% CI, -0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, -1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, -1.06 to 1.95), cholesterol (mean difference, -2.47 mg/dL; 95% CI, -8.51 to 3.57), and HbA1c (mean difference, -0.07%; 95% CI -0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control. In the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation. ClinicalTrials.gov Identifier: NCT03336255.

Association between longitudinal changes in body composition and the risk of kidney outcomes in participants with overweight/obesity and type 2 diabetes mellitus.

To assess the relationship of longitudinal changes in fat mass (FM), lean mass (LM) and waist circumference (WC) with incident kidney outcomes in people with overweight/obesity and type 2 diabetes mellitus (T2DM). A total of 3927 participants with baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 from the Look AHEAD (Action for Health in Diabetes) trial were included. The primary outcome was kidney outcomes, defined as a decrease in eGFR of at least 40% from baseline at follow-up visit, or end-stage kidney disease. During a median follow-up of 8.0 years, 450 kidney outcomes were documented after the first 1 year. In the intensive lifestyle intervention (ILI) group, reductions in FM (per 10% decrease, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.69-0.94) and WC (per 10% decrease, adjusted HR 0.72, 95% CI 0.59-0.88) from baseline to 1-year follow-up were significantly associated with a lower risk of kidney outcomes. The change in LM was not significantly associated with risk of kidney outcomes (per 10% decrease, adjusted HR 0.78, 95% CI 0.58-1.06). In the diabetes support and education group (control group), no significant association was found between changes in body composition and kidney outcomes. Similar results were observed for the 4-year changes in body composition. In this post hoc analysis of the Look AHEAD trial, longitudinal declines in FM and WC were associated with a lower risk of kidney outcomes in the ILI group in participants with overweight/obesity and T2DM.

Integrating a multimodal lifestyle intervention with medical food in prodromal Alzheimer’s disease: the MIND-ADmini randomized controlled trial

BackgroundThe Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people. The LipiDiDiet trial highlighted benefits of medical food in prodromal Alzheimer’s disease (AD). However, the feasibility and impact of multimodal interventions combining lifestyle with medical food in prodromal AD is unclear.MethodsMIND-ADmini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60–85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale.ResultsDuring September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle + medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle + medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed healthy diet improvements (βLifestyle×Time = 1.11, P = 0.038; βLifestyle+medical food×Time = 1.43, P = 0.007); the lifestyle + medical food group also showed vascular risk reduction (P = 0.043) and less cognitive-functional decline (P < 0.05, exploratory analysis). There were 5 serious adverse events (control group: 1; lifestyle intervention: 3; lifestyle + medical food: 1) unrelated to interventions.ConclusionsThe multidomain lifestyle intervention, alone or combined with medical food, had good feasibility and adherence in prodromal AD. Longer-term cognitive and other health benefits should be further investigated in a larger-scale trial.Trial registrationClinicalTrials.gov NCT03249688.

A randomized controlled trial to evaluate the effects of an early postnatal lifestyle modification program on diet, adiposity and metabolic outcome in mothers with gestational diabetes mellitus.

The aim of the present study was to evaluate the effectiveness of a 12-month early postnatal lifestyle intervention program in women with gestational diabetes in a recent pregnancy. This study was a prospective randomized intervention study conducted at a diabetes center in Hong Kong. Chinese women aged 18-45 years, who developed gestational diabetes mellitus (GDM) in their most recent pregnancy, were invited. Eligible women were randomized in 1:1 ratio at baseline (6-12 weeks postpartum), to standard care or lifestyle intervention (diet and physical activity) groups for 12 months. A standardized biochemistry assessment including oral glucose tolerance test, blood lipids, complete blood count, renal and liver functions, were measured at baseline and at 12-month. Anthropometry assessment and lifestyle questionnaire were performed at various timepoints. A total of 103 women were randomized at baseline and a total of 79 women (standard care, n = 39, intervention, n = 40) completed the assessment. After the 12-month study period, women in the intervention group had significantly lower energy intake (intervention, -497.6 ± 488.3 kcal; standard, -222.0 ± 390.0 kcal, P < 0.01) compared to the standard care group, and a trend towards greater weight reduction (intervention, -0.93 ± 4.68 kg; standard, -0.01 ± 3.12 kg, P = 0.36). The lifestyle intervention implemented within 3 months postpartum appeared to promote postpartum weight loss. The early postnatal lifestyle intervention program may provide an opportunity to reduce the long-term risk of diabetes in this high-risk population.

The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW): A study protocol for a single-blind, multi-site, randomized controlled trial.

The Finnish Geriatric Intervention Study (FINGER) led to the global dementia risk reduction initiative: World-Wide FINGERS (WW-FINGERS). As part of WW-FINGERS, the Australian AU-ARROW study mirrors aspects of FINGER, as well as US-POINTER. AU-ARROW is a randomized, single-blind, multisite, 2-year clinical trial (n = 600; aged 55-79). The multimodal lifestyle intervention group will engage in aerobic exercise, resistance training and stretching, dietary advice to encourage MIND diet adherence, BrainHQ cognitive training, and medical monitoring and health education. The Health Education and Coaching group will receive occasional health education sessions. The primary outcome measure is the change in a global composite cognitive score. Extra value will emanate from blood biomarker analysis, positron emission tomography (PET) imaging, brain magnetic resonance imaging (MRI), and retinal biomarker tests. The finalized AU-ARROW protocol is expected to allow development of an evidence-based innovative treatment plan to reduce cognitive decline and dementia risk, and effective transfer of research outcomes into Australian health policy. Study protocol for a single-blind, randomized controlled trial, the AU-ARROW Study.The AU-ARROW Study is a member of the World-Wide FINGERS (WW-FINGERS) initiative.AU-ARROW's primary outcome measure is change in a global composite cognitive score.Extra significance from amyloid PET imaging, brain MRI, and retinal biomarker tests.Leading to development of an innovative treatment plan to reduce cognitive decline.

Medical Nutrition Therapy, In-Person, or Telephone Group Lifestyle Intervention for Type 2 Diabetes? A Qualitative Study of Patient Perceptions and Treatment Preferences.

The purpose of the study was to explore the thoughts, feelings, motivations, and assignment preferences of community health center patients with type 2 diabetes considering participation in a 2-year lifestyle intervention trial aimed at weight loss and increased physical activity. The reasons for patients' delivery mode preferences were also explored to aid in the design of future interventions for controlled trials. Using structured telephone interview guides, 57 patients with type 2 diabetes receiving primary care at 3 community health centers affiliated with an academic medical center were interviewed regarding the perceived pros and cons of each of the 3 possible treatment assignments: telephone conference group, in-person group, or individual medical nutrition therapy. The interview data were organized using NVIVO and analyzed using content analysis. Findings on whether preferences varied by age, gender, or diabetes duration were also examined. Six categories related to patient treatment preferences were identified: (1) perception of time, (2) learning style, (3) comfort, (4) prior experience with weight loss programs and conference calls, (5) desire for support/idea exchange, and (6) accountability. Preferences did not seem to vary by age, gender, or diabetes duration. Key factors influencing preference of treatment assignment included schedule demands, belief about learning style, and past experiences. These findings demonstrate the importance of having a variety of nutrition and lifestyle treatment options available to meet the needs of people with type 2 diabetes.

China Initiative for Multi-Domain Intervention (CHINA-IN-MUDI) to Prevent Cognitive Decline: Study Design and Progress.

Alzheimer's disease (AD), the most common type of irreversible dementia, is predicted to affect 152 million people by 2050. Evidence from large-scale preventive randomized controlled trials (RCTs) on modifiable risk variables in Europe has shown that multi-domain lifestyle treatments for older persons at high risk of dementia may be practical and effective. Given the substantial differences between the Chinese and European populations in terms of demographics and living conditions, direct adoption of the European program in China remains unfeasible. Although a RCT has been conducted in China previously, its participants were mainly from rural areas in northern China and, thus, are not representative of the entire nation.There is an urgent need to establish cohorts that represent different economic, cultural, and geographical situations in order to explore implementation strategies and evaluate the effects of early multi-domain interventions more comprehensively and accurately. We developed an integrated intervention procedure implemented in urban neighborhood settings, namely China Initiative for Multi-Domain Intervention (CHINA-IN-MUDI). CHINA-IN-MUDI is a 2-year multicenter open-label cluster-randomised controlled trial centered around a Chinese-style multi-domain intervention to prevent cognitive decline. Participants aged 60-80 years were recruited from a nationally representative study, i.e. China Healthy Aging and Dementia Study cohort. An external harmonization process was carried out to preserve the original FINGER design. Subsequently, we standardized a series of Chinese-style intervention programs to align with cultural and socioeconomic status. Additionally, we expanded the secondary outcome list to include genomic and proteomic analyses. To enhance adherence and facilitate implementation, we leveraged an e-health application. Screening commenced in July 2022. Currently, 1,965 participants have been randomized into lifestyle intervention (n = 772) and control groups (n = 1,193). Both the intervention and control groups exhibited similar baseline characteristics. Several lifestyle and vascular risk factors were present, indicating a potential window of opportunity for intervention. The intervention will be completed by 2025. This project will contribute to the evaluation of the effectiveness and safety of intervention strategies in controlling AD risk and reducing clinical events, providing a basis for public health decision-making in China.

Effectiveness of Lifestyle Modification Training on Psychological Symptoms and Self-Care in Patients with Type 2 Diabetes

Objective: Diabetes is a disease that endangers the health of many individuals in society. The aim of this study was to evaluate the effectiveness of lifestyle modification training on psychological symptoms and self-care in patients with type 2 diabetes. Methods and Materials: The study employed a pre-test post-test design with experimental and control groups. The research population consisted of all patients with type 2 diabetes from the Diabetes Association and hospitals in Gilangharb province, in 2020. A total of 45 individuals (divided into a lifestyle modification intervention group and a control group) were selected using a convenience sampling method. Data were collected using the SCL-90-R and the Toobert and Glasgow Self-Care Questionnaires. Data were analyzed using multivariate and univariate analysis of covariance tests, as well as the LSD post hoc test, utilizing the SPSS software. Findings: The results of the multivariate analysis of covariance indicated that after controlling for pre-test effects, F was significant at the 0.05 level for "psychological symptoms" components. In other words, there were significant differences in the post-test scores of these variables between the "experimental group" and the "control group". The results also showed differences between the two intervention groups and the control group in the self-care variable. Furthermore, the lifestyle modification training intervention was effective in components of psychological symptoms, including somatization, obsessive-compulsive, anxiety, aggression, phobia, paranoid ideation, and psychoticism dimensions. Conclusion: It can be concluded that lifestyle modification training was effective in improving psychological symptoms and self-care in patients with type 2 diabetes, and this psychological approach can be used to improve the condition of patients with type 2 diabetes.

Protocol for the combined cardiometabolic deep phenotyping and registry-based 20-year follow-up study of the Inter99 cohort

IntroductionThe population-based Inter99 cohort has contributed extensively to our understanding of effects of a systematic screening and lifestyle intervention, as well as the multifactorial aetiology of type 2 diabetes (T2D)...

Effect of health-promoting behaviors and menopausal symptoms of urban women of Hyderabad: A randomized controlled trial.

Menopause, characterized by cessation of menstruation, is accompanied by various physiological and psychological changes. This randomized controlled trial (RCT) investigated the efficacy of a multi-domain lifestyle modification program in alleviating menopausal symptoms and promoting health behaviors among postmenopausal women residing in urban slums of Hyderabad, India. Eighty-two women aged 45-60 years experiencing menopausal symptoms were recruited. Participants were randomly assigned to either a 45-day lifestyle intervention group or a control group receiving standard care. The intervention program addressed six domains: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. The menopause rating scale (MRS) and a modified health-promoting lifestyle II (HPBII) questionnaire assessed menopausal symptoms and health behaviors at baseline and during follow-up. The intervention group showed significant improvements (P < 0.05) in terms of overall HPBII scores compared to baseline, with the most notable changes observed in health responsibility, nutrition, and stress management domains. In addition, MRS scores indicating menopausal symptoms were significantly lowered (P < 0.05) in the intervention group. No significant changes were found in the control group in either health behaviors or menopausal symptoms. After the intervention, the experimental group showed a significant improvement in HPBII scores compared to the control group, particularly in health responsibility, nutrition, interpersonal relationships, and stress management sub-domains. This RCT suggested that a comprehensive lifestyle modification program could effectively improve health behaviors and alleviate menopausal symptoms in postmenopausal women residing in under-resourced settings. Further research is warranted to explore the program's long-term sustainability and generalizability.

Developing Topics.

U.S. POINTER is a Phase 3, multicenter, randomized 2-year clinical trial of two multidomain lifestyle interventions in 2111 older adults who are at increased risk of cognitive decline and dementia due sedentary lifestyle, poor diet, and other factors such as family history of memory impairment and suboptimum cardiovascular health. Enrollment took place at five geographically diverse sites, beginning in 2019 and completing in early 2023. Participants are randomly assigned to one of two lifestyle intervention groups that differ in format, intensity, and accountability. Those randomized to the Self-Guided Lifestyle Intervention receive annual medical monitoring and health education information, tools, and support to encourage increased physical and cognitive activity and a healthier diet through 2-3 annual group meetings. Those randomized to the Structured Lifestyle Intervention receive frequent medical monitoring of cardiovascular health and a structured program of exercise (primarily aerobic), nutritional counseling, cognitive training and social engagement initially through weekly and then monthly group meetings. U.S. POINTER includes partnerships with local chapters of the Alzheimer's Association and lifestyle specialists to assist with intervention delivery. The primary outcome is 2-year change in cognitive function measured with a global cognition composite score that permits harmonization with FINGER and other trials. Secondary and tertiary outcomes include measures of executive function and episodic memory, physical activity, diet, cognitive and physical activity, cardiometabolic disease risks, mood, quality of life, health care costs, and health care utilization. U.S. POINTER is generating a richly phenotyped cohort that will provide a rigorous comparison of two lifestyle interventions designed to preserve cognitive function. It has nurtured 4 ancillary studies to assess intervention effects on outcomes related to sleep quality, brain structure and pathology, peripheral and neurovascular function, and the microbiome. It also partners with clinical trials within the World-Wide FINGERS international network. The study is generating an archive of biospecimens and de-identified public use data. Plans for a post-intervention observational study of the U.S. POINTER cohort are underway. U.S. POINTER provides an important national resource to advance the field in understanding the role of nonpharmacological interventions in reducing risk for cognitive decline and Alzheimer's disease and related dementia.

Older adults participation and adoption among a lifestyle‐based multidomain dementia prevention program

AbstractBackgroundOlder adult participation in lifestyle‐based programs has been described round 80%. (Lee et al., 2018). Participation at dementia prevention programs has been influenced by age, gender, marital status, and interest in receiving health education (Coley et al., 2021). The aim of this study is to evaluate the participation and adoption of lifestyle changes of older adults in a multidomain dementia prevention program from the LatAm Fingers Initiative, in MexicoMethodhealthy cognitive older adults between 60 to 77 years old were recruited. 148 pre‐screenings were done to complete a 100 participants sample, all of them were randomized between Systematic (SIG) (supervised participation) or Flexible FIG (educational advises) Lifestyle Intervention groups (50 per group). Participation is defined as attendance to educational session for physical, nutritional, cognitive and cardiovascular health plus attendance to physical activities, diary diet delivery, and 48 levels per week of cognitive online activities through 6‐months. Participation was classified as low, moderate, and high.ResultMean age was 70.06 (±5.4) years old, and 70.8% participants were females. From 48 participants of the systematic group (SIG) there were two dropouts because problems for traveling, and work. 45% of the SIG, are participating on the four intervention domains. 40 participants are currently at the physical activity intervention. From them high participation and adoption of physical activity was 52.5%, moderate participation was 37.5% and low, 10%. From Nutritional intervention are 26 participants who showed high participation at 57.7%, 11.5% moderate and 30.8%, low. The 21 participants that are at the Cognitive intervention stage, 33.3% had high participation, 52.4% moderate and 14.3% low participation. From the 18 participants at the health intervention stage, 94.4% participants had high participation and 5.6% low.Conclusionfrom this preliminary data, we found that the in the SIG the participation rates, are moderate to high. Physical, nutritional, and cardiovascular health activities showed more than 50% of participation rate. Also, nutritional domain showed the lowest percentage of participation among the four interventions.

Comparison of the Efficacy of Metformin and Lifestyle Modification for the Primary Prevention of Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.

This meta-analysis aimed to compare the effectiveness of metformin versus lifestyle interventions in preventing diabetes in individuals with prediabetes. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and conducted a comprehensive search of databases (PubMed, Cochrane Library, EMBASE) up to September 1, 2023. Five eligible studies were included. The results showed that there was no significant difference in the risk of developing diabetes between the metformin and lifestyle intervention groups (RR: 1.14, 95% CI: 0.77-1.68). Similarly, when comparing metformin with lifestyle intervention, the risk of diabetes was slightly higher in the metformin group, but this difference was not statistically significant (RR: 1.31, 95% CI: 0.93-1.86). When comparing metformin with lifestyle intervention to lifestyle intervention alone, no significant difference was observed in the incidence of diabetes (RR: 0.88, 95% CI: 0.74-1.04). In conclusion, our analysis found that the incidence of type 2 diabetes was slightly higher in patients receiving metformin alone compared to lifestyle intervention, but this difference did not reach statistical significance. Further trials are necessary to better evaluate these interventions for preventing type 2 diabetes in high-risk individuals.

Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors.

Background: Lifestyle interventions for breast cancer survivors have proved effective at stimulating positive behavior change and promoting healthy weight loss, although integrating these programs into clinical practice is challenging. We evaluated the effect of a 6-month, unsupervised, self-guided, lifestyle intervention using printed materials and online videos vs. waitlist group on body weight for breast cancer survivors. Methods: The Lifestyle, Exercise and Nutrition (LEAN) Self-Guided trial randomized breast cancer survivors with a body mass index ≥25 kg/m2 to a 6-month lifestyle intervention (N = 102) or waitlist group (N = 103). Effects of the intervention on self-reported body weight, physical activity (PA), diet quality (via Health Eating Index-2010 (HEI-2010)), and quality of life were assessed using mixed model repeated measures analysis. Results: At 6 months, the intervention arm had significantly greater weight loss compared with the waitlist group (mean difference = -1.3 kg, 95% confidence interval [CI] = -2.5, -0.13). We observed suggestive improvements in PA (mean difference = 18.7 min/week, 95% CI = -24.2, 61.6), diet quality (mean difference in HEI = 3.2 points, 95% CI = -0.20, 6.5), and fatigue (mean difference in Functional Assessment of Chronic Illness Therapy-Fatigue scale = 1.4 points, 95% CI = -1.1, 3.9). Conclusions: The LEAN Self-Guided intervention led to favorable weight changes over 6 months. Low-resource-intensive programs have the potential to be delivered in diverse healthcare settings and may support breast cancer survivors in achieving a healthy body weight.

The short and long-term effects of a lifestyle intervention in children with mental illnesses: a randomized controlled trial (Movementss study)

BackgroundA lifestyle including poor diet, physical inactivity, excessive gaming and inadequate sleep hygiene is frequently seen among Dutch children. These lifestyle behaviors can cause long-term health problems later in life. Unhealthy lifestyle and poor physical health are even more prevalent among children with mental illness (MI) such as autism, attention-deficit/hyperactivity disorder, depression, and anxiety. However, research on lifestyle interventions among children with MI is lacking. As a result, there are currently no guidelines, or treatment programs where children with MI and poor lifestyle can receive effective support. To address these issues and to provide insight into the effectiveness of lifestyle interventions in children with MI and their families, the Movementss study was designed. This paper describes the rationale, study design, and methods of an ongoing randomized controlled trial (RCT) comparing the short-term (12 weeks) and long-term (1 year) effects of a lifestyle intervention with care as usual (CAU) in children with MI and an unhealthy lifestyle.MethodsA total of 80 children (6–12 years) with MI according to DSM-V and an unhealthy lifestyle are randomized to the lifestyle intervention group or CAU at a specialized child and adolescent mental hospital. The primary outcome measure is quality of life measured with the KIDSCREEN. Secondary outcomes include emotional and behavior symptoms, lifestyle parameters regarding diet, physical activity, sleep, and screen time, cognitive assessment (intelligence and executive functions), physical measurements (e.g., BMI), parenting styles, and family functioning, prior beliefs, adherence, satisfaction, and cost-effectiveness. Assessments will take place at the start of the study (T0), after 12 weeks (T1), six months (T2), and 12 months of baseline (T3) to measure long-term effects.DiscussionThis RCT will likely contribute to the currently lacking knowledge on lifestyle interventions in children with MI.Trial registrationtrialsearch.who.int/ NL9822. Registered at November 2nd, 2021.

The long-term effect of intentional weight loss on changes in bone mineral density in persons with type 2 diabetes: results from the Look AHEAD randomized trial

SummaryIntentional weight loss has been shown to increase bone loss short term but the long-term effects are not known. Data from the Look AHEAD clinical trial shows that a long term intentional weight loss intervention was associated with greater bone loss at the hip in men.PurposeIntentional weight loss has been shown to increase bone loss short term and increase frailty fracture risk, but the long-term effects on bone mineral density (BMD) are not known.MethodsData from a subgroup from the Look AHEAD (LA) multicenter, randomized clinical trial was used to evaluate whether a long term intentional weight loss intervention would increase bone loss. In a preplanned substudy, BMD was assessed at 5 of the 16 LA clinical centers using dual-energy X-ray absorptiometry at baseline, year 8, and the observational visit 12.6–16.3 years after randomization (year 12–16).ResultsAt year 8, bone density loss (%) was greater in the Intensive Lifestyle Intervention (ILI) group compared with the control group (DSE) for the femoral neck (p = 0.0122) but this finding was not observed at the year 12–16 visit. In analyses stratified by gender, bone density loss (%) was greater at the total hip for men in the ILI group than the DSE group at both the year 8 and year 12–16 visits (year 8 p = 0.0263 and year 12–16 p = 0.0062). This finding was not observed among women.ConclusionLong term intentional weight loss was associated with greater bone loss at the hip in men. These results taken with the previously published Look AHEAD data from the entire clinical trial showing increased frailty fracture risk with weight loss in the ILI group suggest that when intentional weight loss is planned, consideration of bone density preservation and fracture prevention strategies is warranted.Trial RegistrationClinicaltrials.gov Identifier: NCT00017953. June 21, 2001

Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial

Impaired glucose regulation (defined as either impaired glucose tolerance or impaired fasting glucose) is an important risk factor for the development of diabetes. We aimed to evaluate the safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing diabetes in Chinese participants with impaired glucose regulation. We did a multicentre, open-label, randomised controlled trial at 43 endocrinology departments in general hospitals across China. Eligible participants were individuals with impaired glucose regulation (ie, impaired glucose tolerance or impaired fasting glucose, or both), men or women aged 18-70 years with a BMI of 21-32 kg/m2. Eligible participants were randomly assigned (1:1) via a computer-generated randomisation to receive either standard lifestyle intervention alone or metformin (850 mg orally once per day for the first 2 weeks and titrated to 1700 mg orally per day [850 mg twice per day]) plus lifestyle intervention. Block randomisation was used with a block size of four, stratified by glucose status (impaired fasting glucose or impaired glucose tolerance), hypertension, and use of any anti-hypertensive medication. Lifestyle intervention advice was given by investigators at all participating sites. The primary endpoint was the incidence of newly diagnosed diabetes at the end of the 2-year follow-up. Analysis was done using the full analysis set and per-protocol set. This study is registered with ClinicalTrials.gov, number NCT03441750, and is completed. Between April, 2017, and June, 2019, 3881 individuals were assessed for eligibility, of which 1678 (43·2%) participants were randomly assigned to either the metformin plus lifestyle intervention group (n=831) or the lifestyle intervention alone group (n=847) and received the allocated intervention at least once. During a median follow-up of 2·03 years, the incidence rate of diabetes was 17·27 (95% CI 15·19-19·56) per 100 person-years in the metformin plus lifestyle intervention group and 19·83 (17·67-22·18) per 100 person-years in the lifestyle intervention alone group. The metformin plus lifestyle intervention group showed a 17% lower risk of developing diabetes than the lifestyle intervention alone group (HR 0·83 [95% CI 0·70-0·99]; log-rank p=0·043). A higher proportion of participants in the metformin plus lifestyle intervention group reported adverse events than in the lifestyle intervention alone group, primarily due to more gastrointestinal adverse events. The percentage of participants reporting a serious adverse event was similar in both groups. Metformin plus lifestyle intervention further reduced the risk of developing diabetes than lifestyle intervention alone in Chinese people with impaired glucose regulation, showing additional benefits of combined intervention in preventing progression to diabetes without new safety concerns. Merck Serono China, an affiliate of Merck KGaA, Darmstadt, Germany. For the Chinese translation of the abstract see Supplementary Materials section.

Antibiotic Treatment During Pregnancy and the First Six Months Postpartum - a Secondary Analysis of the "Healthy Living in Pregnancy" (GeliS) Study.

Antibiotic therapies for the treatment of bacterial infections pose a particular challenge during pregnancy and breastfeeding. For Germany, there is hardly any information on the frequency of antibiotic use during this phase. Our analysis uses data from the "Healthy Living in Pregnancy" (GeliS) study to describe antibiotic treatments during pregnancy and in the first six months after birth (postpartum), and to compare their use with existing recommendations. This is a retrospective secondary analysis of the GeliS study. In the cluster randomized lifestyle intervention study, detailed information on antibiotic therapies during pregnancy and postpartum was collected using surveys. Chi-square tests and generalized estimating equations were used for evaluation. Of the 1636 women included in the analysis, 21% reported antibiotic treatment at least once during pregnancy (14%) or in the first six months postpartum (7%). During pregnancy, the antibiotic therapies of women increased from 1.7% in the first trimester to 6.5% in the third trimester. Common reasons for treatment were urinary tract infections (7.3% of women), ear, nose, throat (ENT) infections (3.6%), and birth complications (2.6%). The information on the prescribed preparations corresponded to the current recommendations. A significant increase in the frequency of treatment with antibiotics was observed in the lifestyle intervention group (p<0.001), in participants without a partner (p<0.001), and in women who breastfed their children (p=0.005) or gave birth by caesarean section (p=0.003) or prematurely (p=0.012). Other socioeconomic or lifestyle factors were not significant. Approximately one in five women receives at least one antibiotic treatment during pregnancy and breastfeeding that meets current treatment recommendations. Treatment with antibiotics is more common in premature births, caesarean sections, and breastfeeding women.