Community-based Lifestyle Program Research Articles

Perceptions of the acceptability and effectiveness of a localised lifestyle medicine initiative to improve mental health – the lift project

ABSTRACT Objective Evaluate survey respondents’ perceptions concerning the acceptability and effectiveness of a localised, community-based mental health program. Method Avondale University and Lake Macquarie City Council partnered to implement an online, lifestyle-based program for all Council residents during a COVID-19 lockdown period. The University and Council promoted the program through established networks, resulting in 2390 registrations representing 4041 participants. Researchers invited registered users to respond to a post-program survey assessing their perceptions concerning program satisfaction, mental health benefits, and self-efficacy for managing mental health. Qualitative questions probed respondents’ likes and dislikes and were analysed thematically. Results Response rates were low, 6% (138/2390) of registered participants completed the post-program survey. Of the 138 responses, 99% indicated they would recommend the program to others, and 94% believed they gained skills to manage their mental well-being into the future. Themes generated from the qualitative data indicated that respondents liked the video content and delivery style, community camaraderie, personal empowerment, and easy accessibility. Some respondents found online accessibility problematic, disliked the delivery style, and experienced technical difficulties. Discussion The findings from a limited number of respondents indicate that a localised, community-based lifestyle program may offer a replicable model that is acceptable and effective in improving perceived mental health and self-efficacy in managing mental well-being. Survey respondents valued the practical content, community togetherness and emphasis on self-empowerment.

Changes in weight status of caregivers of children and adolescents enrolled in a community-based healthy lifestyle programme: Five-year follow-up

Whānau Pakari is a family-centred healthy lifestyle programme for children/adolescents with overweight/obesity in New Zealand. This secondary analysis from our randomised trial within the clinical service assessed 5-year BMI changes in accompanying caregivers (n = 23), mostly mothers. Overall, baseline and 5-year caregivers’ BMI were similar (32.50 vs 31.42 kg/m2, respectively; p = 0.31) but two-thirds (65%) experienced BMI reductions. Five-year BMI change was similar in High-intensity and Low-intensity randomisation groups [–1.37 kg/m2 (–4.95, 2.21); p = 0.44]. Caregiver’s BMI change was not associated with child’s BMI change. Despite no overall BMI reduction, our findings contrast with upward BMI trajectories predicted for NZ adults with overweight/obesity.

A Multisource Process Evaluation of a Community-Based Healthy Lifestyle Programme for Child and Adolescent Obesity.

Whānau Pakari is a healthy lifestyle assessment and intervention programme for children and adolescents with obesity in Taranaki (Aotearoa/New Zealand), which, in this region, replaced the nationally funded Green Prescription Active Families (GRxAF) programme. We compared national referral rates from the GRxAF programme (age 5-15 years) and the B4 School Check (B4SC, a national preschool health and development assessment) with referral rates in Taranaki from Whānau Pakari. We retrospectively analysed 5 years of clinical data (2010-2015), comparing referral rates before, during, and after the Whānau Pakari clinical trial, which was embedded within the programme. We also surveyed programme referrers and stakeholders about their experiences of Whānau Pakari, analysing their responses using a multiple-methods framework. After the Whānau Pakari trial commenced, Taranaki GRxAF referral rates increased markedly (2.3 pretrial to 7.2 per 1000 person-years), while NZ rates were largely unchanged (1.8-1.9 per 1000 person-years) (p < 0.0001 for differences during the trial). Post-trial, Taranaki GRxAF referral rates remained higher irrespective of ethnicity, being 1.8 to 3.2 times the national rates (p < 0.001). Taranaki B4SC referrals for obesity were nearly complete at 99% in the last trial year and 100% post-trial, compared with national rates threefold lower (31% and 32%, respectively; p < 0.0001), with Taranaki referral rates for extreme obesity sustained at 80% and exceeding national rates for both periods (58% and 62%, respectively; p < 0.01). Notably, a referral was 50% more likely for referrers who attended a Whānau Pakari training half-day (RR = 1.51; p = 0.009). Stakeholders credited the success of Whānau Pakari to its multidisciplinary team, family-centred approach, and home-based assessments. However, they highlighted challenges such as navigating multidisciplinary collaboration, engaging with families with complex needs, and shifting conventional healthcare practices. Given its favourable referral trends and stakeholder endorsement, Whānau Pakari appears to be a viable contemporary model for an accessible and culturally appropriate intervention on a national and potentially international scale.

Testosterone Treatment, Weight Loss, and Health-related Quality of Life and Psychosocial Function in Men: A 2-year Randomized Controlled Trial.

To determine the effect of testosterone vs placebo treatment on health-related quality of life (HR-QOL) and psychosocial function in men without pathologic hypogonadism in the context of a lifestyle intervention. Secondary analysis of a 2-year randomized controlled testosterone therapy trial for prevention or reversal of newly diagnosed type 2 diabetes, enrolling men ≥ 50 years at high risk for type 2 diabetes from 6 Australian centers. Injectable testosterone undecanoate or matching placebo on the background of a community-based lifestyle program. Self-reported measures of HR-QOL/psychosocial function. Of 1007 participants randomized into the Testosterone for Type 2 Diabetes Mellitus (T4DM) trial, 648 (64%) had complete data available for all HR-QOL/psychosocial function assessments at baseline and 2 years. Over 24 months, while most measures were not different between treatment arms, testosterone treatment, compared with placebo, improved subjective social status and sense of coherence. Baseline HR-QOL/psychosocial function measures did not predict the effect of testosterone treatment on glycemic outcomes, primary endpoints of T4DM. Irrespective of treatment allocation, larger decreases in body weight were associated with improved mental quality of life, mastery, and subjective social status. Men with better baseline physical function, greater sense of coherence, and fewer depressive symptoms experienced greater associated decreases in body weight, with similar effects on waist circumference. In this diabetes prevention trial, weight loss induced by a lifestyle intervention improved HR-QOL and psychosocial function in more domains than testosterone treatment. The magnitude of weight and waist circumference reduction were predicted by baseline physical function, depressive symptomology, and sense of coherence.

Improving mental health in black men through a 24-week community-based lifestyle change intervention: the black impact program

BackgroundPoor mental health is a leading cause of morbidity and mortality among Black men in the United States. Efforts to improve mental health among Black men have been hampered by a lack of access and utilization of mental health services. Physical activity and social networks have been shown to improve mental health. Thus, we examined the effect of a community team-based physical activity, health education and social needs intervention among Black men on mental health over 24 weeks.MethodsBlack adult males (n = 74) from a large Midwestern city participated in Black Impact, a 24-week community-based lifestyle change program adapted from the Diabetes Prevention Program and American Heart Association’s (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA’s Life’s Simple 7 (LS7) framework. Measures of mental health including the Center for Epidemiological Studies Depression Scale (CES-D), Patient Health Questionnaire 2-question depression screener (PHQ-2), and Perceived Stress Scale-10 (PSS-10) were completed at baseline, 12 and 24 weeks. The change in mental health scores from baseline to 12 and 24 weeks were evaluated using linear mixed-effects models adjusting for age, education, and income. The change in cardiovascular health scores, defined as objective metrics of LS7 (LS5 [blood pressure, total cholesterol, fasting glucose, body mass index and smoking]), by baseline mental health were evaluated using linear mixed-effects models with an interaction term (time*baseline mental health variable) and a random intercept for each participant.ResultsAmong 71 Black men (mean age 51, 85% employed) at 24 weeks, CES-D scores decreased from 10.54 to 7.90 (-2.64, 95%CI:-4.74, -0.55), PHQ-2 decreased from 1.04 to 0.63 (-0.41, 95%CI: -0.75, -0.07), and PSS-10 decreased from 14.62 to 12.91 (-1.71, 95%CI: -3.53, 0.12). A 1-unit higher CES-D at baseline was associated with less improvement in LS5 scores by -0.04 (95%CI: -0.076, -0.005) and − 0.032 (95%CI:-0.067, 0.003) units at week 12 and 24, respectively, with similar findings for PSS.ConclusionsThe Black Impact community-based lifestyle program has the potential to reduce depressive symptoms and stress in Black men. There is a dire need for larger, randomized studies to test the impact of Black Impact on mental health in Black men to advance health equity.Trial RegistrationRetrospectively Registered, ClinicalTrials.gov Identifier: NCT04787978.

Live More Abundantly: A community-based lifestyle education program addressing selected chronic disease risk factors in Fiji—a pilot study

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Can Health Improvements from a Community-Based Exercise and Lifestyle Program for Older Adults with Type 2 Diabetes Be Maintained? A Follow up Study

Background: Older people consistently report a desire to remain at home. Beat It is a community-based exercise and lifestyle intervention that uses evidence-based strategies to assist older people with type 2 diabetes mellitus (T2DM) to improve physical and functional fitness, which are crucial to maintain independence. This follow up, real-world study assessed the efficacy of Beat It and whether older adults with T2DM were able to maintain improvements in physical activity, waist circumference and fitness one year post completion. Methods: We have previously reported methods and results of short-term outcomes of Beat It. This paper reports anthropometric measurements and physical fitness outcomes of Beat it at 12-months post program completion and compares them to validated standards of fitness required to retain physical independence. Results: Improvements that were observed post program were maintained at 12 months (n = 43). While the number of participants who met fitness standards increased post program, not all increases were maintained at 12 months. Conclusions: This study provides promising early evidence that an eight-week, twenty-hour community-based clinician-led exercise and lifestyle program can improve health outcomes in older adults with T2DM which were retained for at least a year after program completion.

Ongoing Community-Based Whole-Food, Plant-Based Lifestyle Effectively Preserves Muscle Mass during Body Mass Loss

Body fat and muscle mass showed opposing associations with mortality. The results of research on the effectiveness of popular body mass (BM) loss diets in obese subjects showed 20 to 30% loss of muscle mass within the total BM loss; conversely, when the subjects used a whole-food, plant-based (WFPB) diet, the loss was up to 42%. Therefore, we suggest an improvement. The aim of this retrospective analysis of data was to examine the assessment of changes in the body composition of 217 participants from all over Slovenia who joined our ongoing, community-based WFPB lifestyle programme from 2016 to 2021 and underwent two successive measurements of medically approved bioelectrical impedance. The WFPB lifestyle programme consisted of (i) nutrition, (ii) physical activity (PA) and (iii) a support system. The primary outcomes included the (vector of) change of body fat mass (BFM) per body height (BH), fat-free mass (FFM) per BH and whole-body phase angle (PhA) from the initial values to the first follow-up (FU) of the whole sample and for both sexes. Further, we examined the FFM change within the total BM loss according to their BMI classification and depending on how much BM they lost (5 kg &lt; BM ≥ 5 kg) within the FU time (103.6 ± 89.8 day). Participants experienced a decrease in BFM per BH (−0.02 ± 0.02 kg/cm, p &lt; 0.001), no change in FFM and an increase in PhA (0.2 ± 0.7°, p &lt; 0.001). Importantly, the participants in the obesity BMI class achieved only partial FFM preservation (−1.5 ± 3.6 kg, p = 0.032 of FFM loss (20%) within −7.5 ± 6.1 kg, p &lt; 0.001 of BM loss). However, the participants who lost BM &lt; 5 kg had a significantly increased FFM (0.8 ± 3.2 kg, p = 0.001 of FFM (57%) within −1.4 ± 1.8 kg, p &lt; 0.001 of BM loss), whereas the participants who lost BM ≥ 5 kg experienced a decrease in FFM (−2.2 ± 3.9 kg, p &lt; 0.001 of FFM (−25%) within −8.8 ± 5.2 kg, p &lt; 0.001 of BM loss). To conclude, the WFPB lifestyle, on average, effectively preserved FFM during BM and/or BFM loss among the normal and pre-obesity BMI classes but only partially among the obese BMI class and those who lost ≥ 5 kg of BM. Importantly, a customized PA strategy is needed for obese BMI class participants, where general resistance training is not possible or safe in order to preserve their muscle mass more effectively. In addition, muscle mass preservation is important for further improvements of BM, body composition and visual body image.

Facilitators and barriers for lifestyle change in people with prediabetes: a meta-synthesis of qualitative studies

BackgroundThe increasing prevalence of type 2 diabetes worldwide is a major global public health concern. Prediabetes is a reversible condition and is seen as the critical phase for the prevention of type 2 diabetes. The aim of this study is to identify and synthesize current evidence on the perceived barriers and facilitators of lifestyle change among people with prediabetes in terms of both initial change and lifestyle change maintenance.MethodsA systematic literature search in six bibliographic databases was conducted in April 2021. Potential studies were assessed for eligibility based on pre-set criteria. Quality appraisal was done on the included studies, and the thematic synthesis approach was applied to synthesize and analyse the data from the included studies.ResultsTwenty primary studies were included, containing the experiences of 552 individuals. Thirteen studies reported participants perceived facilitators and barriers of lifestyle change when taking part in community-based lifestyle intervention programs, while seven studies reported on perceived facilitators and barriers of lifestyle change through consultations with health care professionals (no intervention involved).Three analytical themes illuminating perceived barriers and facilitators for lifestyle change were identified: 1) the individual’s evaluation of the importance of initiating lifestyle change, 2) the second theme was strategies and coping mechanisms for maintaining lifestyle changes and 3) the last theme was the significance of supportive relations and environments in initiating and maintaining lifestyle change.ConclusionAwareness of prediabetes and the perception of its related risks affects the motivation for lifestyle change in people at risk of type 2 diabetes; but this does not necessarily lead to lifestyle changes. Facilitators and barriers of lifestyle change are found to be in a complex interplay within multiple ecological levels, including the interpersonal, intrapersonal, environmental and policy level. An integrated understanding and analysis of the perceived barriers and facilitators of lifestyle change might inform people with prediabetes, healthcare professionals, and policy makers in terms of the need for psychological, social, and environmental support for this population.

A Qualitative Evaluation of a Community-Based Intervention on Health-Related Behaviors in Disadvantaged Women

ABSTRACT Purpose: Grounded in social ecological model and self-determination theory, the aim of this study was to qualitatively evaluate the first and second year follow-ups of a community-based healthy lifestyle programme on health-related behaviors, and outcomes in disadvantaged adult women. Methods: Eleven disadvantaged adult women (M = 37.72; SD = 8.34) (seven of them from the Roma population) participated in this community-based participatory action research. Discussion groups, semi-structured interviews, and field notes were used to assess the effects of the intervention programme on health-related behaviors and health outcomes through thematic analysis. Results: Women perceived improvements in PA-related variables, healthy eating, and other health-related outcomes throughout two years. Most women mentioned these behavior changes in the first year, while others perceived them in the second year. Conclusions: These findings highlight the importance of developing contextual and culturally tailored interventions that address the specific problems and needs that emerge from ethnic groups. Given that some of these behavior changes were only mentioned by most of these women in the second year, long-term interventions seem to be ideally required in this population.

Abstract 12916: Improving Cardiovascular Health in Black Men Through a 24-week Community-Based Lifestyle Change Intervention: The Black Impact Program

Introduction: Higher cardiovascular health scores, using American Heart Association’s (AHA) Life’s Simple 7 (LS7), have been associated with lower risk of cardiovascular disease, type 2 diabetes, cancer and mortality among all racial/ethnic groups. Nationally, Black men have the lowest levels of LS7. Thus, a study was conducted to evaluate the impact of a community-based lifestyle change program on LS7 among Black men. Hypothesis: A community-based lifestyle change program will increase levels of LS7 among Black men. Methods: Black adult males (n=74) from a large Midwestern city participated in Black Impact, a 24-week community-based lifestyle change program adapted from the Diabetes Prevention Program and AHA’s Check, Change, Control Blood Pressure Self-Management Program which incorporates AHA’s LS7 framework. The change in a LS7 score (range 0-14) from baseline to 12 and 24 weeks was evaluated using a linear mixed effects model adjusted for age, education and income. Results: The mean age of participants was 52 ±10 years. The men were sociodemographically diverse with annual income ranging from &lt;$20,000 (7%) to ≥$75,000 (25%). Twenty-five percent were college graduates, 73% had private insurance and 84% were employed. In fully adjusted models, LS7 score at baseline was 7.12 and increased 0.67 (95%CI: 0.14, 1.20, p=0.013) and 0.93 (95%CI: 0.40, 1.46, p=&lt;0.001) points at 12 and 24 weeks, respectively, compared to baseline. Sensitivity analysis evaluating 5 components (excluding diet and physical activity) and 6 components (excluding diet) also showed significant increases at 12 and 24 weeks (all p&lt;0.01). Conclusions: The Black Impact lifestyle change single-arm pilot program showed that a community-based lifestyle intervention has the potential to improve LS7 in Black men. Further randomized studies are urgently needed to improve cardiovascular health and advance cardiovascular health equity in Black men.

Effect of a community-based lifestyle intervention programme on quality of life among German women

Abstract Background Quality of life is an important concept in the field of health, which can be influenced by various lifestyle factors. The objective was to test if a community-based lifestyle programme would beneficially affect the health-related quality of life of German women. Methods The controlled intervention study had a total duration of 24 months. Quality of life (EQ-5D-3L), anthropometrics, vital and blood parameters as well as diagnosed diseases and health economic parameters were collected at baseline (t0), after 10 weeks (t1) and after 6 months (t2). For the intervention group (n = 65) a 10-week intensive lifestyle programme followed by monthly alumni meetings were conducted. The intensive phase consisted of 14 consecutive seminars about a healthy lifestyle, which focused on a plant-based diet, physical activity, stress management and community support. The control group (n = 35) received no intervention. Results The first descriptive health profile results of the subgroup analysis showed that 59% women of the intervention group at t0 (t1: 37%; t2: 48%) and 60% of the control group at t0 (t1: 54%; t2: 49%) reported problems in at least one of the EQ-5D dimensions (mobility, selfcare, activities, pain, and anxiety). A significant difference in EQ VAS change between women in intervention (7,15 [95% CI 4,32; 9,98]; EQ VAS t0: 75,35 [SD 13,71]) and control group (-2,63 [95% CI -5,40; 0,15]; EQ VAS t0: 78,80 [SD 18,51]) from t0 to t1 was observed (p &amp;lt; 001; adjusted for baseline). No significant differences in mean EQ VAS change from t0 to t2 and in mean EQ-5D index change from t0 to t1 and t0 to t2 between the groups were observed (p &amp;gt; 0,05; adjusted for baseline). Conclusions The preliminary results suggest that the lifestyle intervention programme can have a positive short-time effect on some aspects of quality of life, such as the health profile and EQ VAS. However, the long-term results will be shown in the future. Key messages A healthy lifestyle can affect the quality of life in a positive way. The community-based lifestyle programme had a short-time influence on the descriptive health profile and EQ VAS of German women, whereby the EQ index didńt change significantly between the groups.

Community-Based Exercise and Lifestyle Program Improves Health Outcomes in Older Adults with Type 2 Diabetes

Background: The aim of this study was to assess the efficacy of Beat It—a community-based exercise and lifestyle intervention—in improving anthropometric and physical fitness outcomes in older adults with type 2 diabetes mellitus (T2DM). Methods: Australians with T2DM who were aged 60 years or older were included. These individuals were enrolled in Beat It, a twice-weekly supervised group exercise and education program conducted over 8 weeks. Anthropometric measurements and physical fitness parameters were assessed at baseline and completion. Physical fitness measures were then compared to validated criterion standards of fitness levels required by older adults to remain physically independent into later life. Results: A total of 588 individuals were included in the study. At baseline, a substantial proportion of the cohort had physical fitness measures that were below the standard for healthy independent living for their gender and age. Significant improvements in waist circumference and physical fitness were observed post program and resulted in an increase in the number of participants who met the standard for healthy independent living. Conclusions: Participation in Beat It improved important health outcomes in older adults with T2DM. A longer-term follow-up is needed to determine whether these positive changes were maintained beyond the delivery of the program.

The influence of partners on successful lifestyle modification in patients with coronary artery disease

BackgroundMarital status is associated with prognosis in patients with cardiovascular disease (CVD). However, the influence of partners on successful modification of lifestyle-related risk factors (LRFs) in secondary CVD prevention is unclear. Therefore, we studied the association between the presence of a partner, partner participation in lifestyle interventions and LRF modification in patients with coronary artery disease (CAD). MethodsIn a secondary analysis of the RESPONSE-2 trial (n = 711), which compared nurse-coordinated referral to community-based lifestyle programs (smoking cessation, weight reduction and/or physical activity) to usual care in patients with CAD, we investigated the association between the presence of a partner and the level of partner participation on improvement in >1 LRF (urinary cotinine <200 ng/l, ≥5% weight reduction, ≥10% increased 6-min walking distance) without deterioration in other LRFs at 12 months follow-up. ResultsThe proportion of patients with a partner was 80% (571/711); 19% women (108/571). In the intervention group, 48% (141/293) had a participating partner in ≥1 lifestyle program. Overall, the presence of a partner was associated with patients' successful LRF modification (adjusted risk ratio (aRR) 1.93, 95% confidence interval (CI) 1.40–2.51). A participating partner was associated with successful weight reduction (aRR 1.73, 95% CI 1.15–2.35). ConclusionThe presence of a partner is associated with LRF improvement in patients with CAD. Moreover, patients with partners participating in lifestyle programs are more successful in reducing weight. Involving partners of CAD patients in weight reduction interventions should be considered in routine practice.

Effect of Testosterone Treatment on Bone Microarchitecture and Bone Mineral Density in Men: A 2-Year RCT.

Testosterone treatment increases bone mineral density (BMD) in hypogonadal men. Effects on bone microarchitecture, a determinant of fracture risk, are unknown. We aimed to determine the effect of testosterone treatment on bone microarchitecture using high resolution-peripheral quantitative computed tomography (HR-pQCT). Men ≥ 50 years of age were recruited from 6 Australian centers and were randomized to receive injectable testosterone undecanoate or placebo over 2 years on the background of a community-based lifestyle program. The primary endpoint was cortical volumetric BMD (vBMD) at the distal tibia, measured using HR-pQCT in 177 men (1 center). Secondary endpoints included other HR-pQCT parameters and bone remodeling markers. Areal BMD (aBMD) was measured by dual-energy x-ray absorptiometry (DXA) in 601 men (5 centers). Using a linear mixed model for repeated measures, the mean adjusted differences (95% CI) at 12 and 24 months between groups are reported as treatment effect. Over 24 months, testosterone treatment, versus placebo, increased tibial cortical vBMD, 9.33 mg hydroxyapatite (HA)/cm3) (3.96, 14.71), P < 0.001 or 3.1% (1.2, 5.0); radial cortical vBMD, 8.96 mg HA/cm3 (3.30, 14.62), P = 0.005 or 2.9% (1.0, 4.9); total tibial vBMD, 4.16 mg HA/cm3 (2.14, 6.19), P < 0.001 or 1.3% (0.6, 1.9); and total radial vBMD, 4.42 mg HA/cm3 (1.67, 7.16), P = 0.002 or 1.8% (0.4, 2.0). Testosterone also significantly increased cortical area and thickness at both sites. Effects on trabecular architecture were minor. Testosterone reduced bone remodeling markers CTX, -48.1 ng/L [-81.1, -15.1], P < 0.001 and P1NP, -6.8 μg/L[-10.9, -2.7], P < 0.001. Testosterone significantly increased aBMD at the lumbar spine, 0.04 g/cm2 (0.03, 0.05), P < 0.001 and the total hip, 0.01 g/cm2 (0.01, 0.02), P < 0.001. In men ≥ 50 years of age, testosterone treatment for 2 years increased volumetric bone density, predominantly via effects on cortical bone. Implications for fracture risk reduction require further study.

Benefits of adding food education sessions to an exercise programme on cardiovascular risk factors in patients with type 2 diabetes.

To evaluate the impact of adding food education sessions to an exercise programme on cardiovascular risk factors in middle-aged and older patients with type 2 diabetes (T2D), a randomised parallel-group study was performed. Glycated haemoglobin, body mass index (BMI), waist circumference, fat mass (FM) and blood pressure were assessed at baseline and after 9 months. The recruitment was made in three primary healthcare centres from Vila Real, Portugal. Thirty-three patients (65⋅4 ± 5⋅9 years old) were engaged in a 9-month community-based lifestyle intervention programme: a supervised exercise programme (EX; n = 15; combined aerobic, resistance, agility/balance and flexibility exercise; three sessions per week; 75 min per session); or the same exercise programme plus concomitant food education sessions (EXFE; n = 18; 15-min lectures and dual-task strategies during exercise (answer nutrition questions while walking); 16 weeks). Significant differences between groups were identified in the evolution of BMI (P < 0.001, ) and FM (P < 0.001, ), with best improvements observed in the EXFE group. The addition of a simple food education dietary intervention to an exercise programme improved body weight and composition, but not glycaemic control and blood pressure in middle-aged and older patients with T2D.

Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial

Men who are overweight or obese frequently have low serum testosterone concentrations, which are associated with increased risk of type 2 diabetes. We aimed to determine whether testosterone treatment prevents progression to or reverses early type 2 diabetes, beyond the effects of a community-based lifestyle programme. T4DM was a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial done at six Australian tertiary care centres. Men aged 50-74 years, with a waist circumference of 95 cm or higher, a serum testosterone concentration of 14·0 nmol/L or lower but without pathological hypogonadism, and impaired glucose tolerance (oral glucose tolerance test [OGTT] 2-h glucose 7·8-11·0 mmol/L) or newly diagnosed type 2 diabetes (provided OGTT 2-h glucose ≤15·0 mmol/L) were enrolled in a lifestyle programme and randomly assigned (1:1) to receive an intramuscular injection of testosterone undecanoate (1000 mg) or placebo at baseline, 6 weeks, and then every 3 months for 2 years. Randomisation was done centrally, including stratification by centre, age group, waist circumference, 2-h OGTT glucose, smoking, and first-degree family history of type 2 diabetes. The primary outcomes at 2 years were type 2 diabetes (2-h OGTT glucose ≥11·1 mmol/L) and mean change from baseline in 2-h OGTT glucose, assessed by intention to treat. For safety assessment, we did a masked monitoring of haematocrit and prostate-specific antigen, and analysed prespecified serious adverse events. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12612000287831. Between Feb 5, 2013, and Feb 27, 2017, of 19 022 men who were pre-screened, 1007 (5%) were randomly assigned to the placebo (n=503) and testosterone (n=504) groups. At 2 years, 2-h glucose of 11·1 mmol/L or higher on OGTT was reported in 87 (21%) of 413 participants with available data in the placebo group and 55 (12%) of 443 participants in the testosterone group (relative risk 0·59, 95% CI 0·43 to 0·80; p=0·0007). The mean change from baseline 2-h glucose was -0·95 mmol/L (SD 2·78) in the placebo group and -1·70 mmol/L (SD 2·47) in the testosterone group (mean difference -0·75 mmol/L, -1·10 to -0·40; p<0·0001). The treatment effect was independent of baseline serum testosterone. A safety trigger for haematocrit greater than 54% occurred in six (1%) of 484 participants in the placebo group and 106 (22%) of 491 participants in the testosterone group, and a trigger for an increase of 0·75 μg/mL or more in prostate-specific antigen occurred in 87 (19%) of 468 participants in the placebo group and 109 (23%) of 480 participants in the testosterone group. Prespecified serious adverse events occurred in 37 (7·4%, 95% CI 5·4 to 10·0) of 503 patients in the placebo group and 55 (10·9%, 8·5 to 13·9) of 504 patients in the testosterone group. There were two deaths in each group. Testosterone treatment for 2 years reduced the proportion of participants with type 2 diabetes beyond the effects of a lifestyle programme. Increases in haematocrit might be treatment limiting. Longer-term durability, safety, and cardiovascular effects of the intervention remain to be further investigated. Australian National Health and Medical Research Council, Bayer, Eli Lilly, University of Adelaide, and WW (formerly Weight Watchers).

Lifestyle Intervention for Cardiovascular Disease Risk Factors in Jeddah, Saudi Arabia.

BackgroundCardiovascular disease (CVD) remains the major cause of global mortality. Applying a comprehensive interventional program may reduce the incidence of cardiovascular disease and its complications.ObjectiveThis study compared the effects of a three-month intervention involving lifestyle modification and physical activity with standard care in women ≥30 years having a moderate to high risk of CVD, with respect to improving physical activity and cardiovascular disease risk factors at the National Guard Residential City in Jeddah, Saudi Arabia, in 2015.MethodsThe effects of this community-based lifestyle program were assessed through a randomized controlled trial from January 1st to September 6th, 2015. Women in the intervention group (n = 31) received health education, exercise training, and diet counselling as individuals and in groups according to the participant’s risk. Women in the control group (n = 28) received one health education session at the screening site. The primary outcome was the proportion of women with moderate Framingham risk scores (FRS) reducing their risk by 10% and the proportion of women with high FRS reducing their risk by 25%. The secondary outcome was the proportion of women reducing their risk by ≥1 risk category.ResultsThe mean participant age was 42 ± 8 years. At three-month’s follow-up, reductions were greater in the intervention group and the difference between groups was statistically significant (p < 0.05). Lifestyle intervention program significantly reduced systolic blood pressure (-9.2 mmHg), blood glucose (-45 mg/dL) and Framingham risk score (-13.6). Linear regression analysis revealed a significant improvement in the Framingham risk score (p < 0.01).ConclusionIn a population of women with moderate-to-high risk of CVD, a personalized lifestyle modification program showed positive association in improving the 10-year cardiovascular Framingham risk score after three months.

Promoting quality of life and recovery in adults with mental health issues using exercise and nutrition intervention

Background Interventions that promote exercise and a healthy diet can improve quality of life and may promote recovery for people with mental health issues. The aim of this study was to evaluate a community-based lifestyle program for adults with mental health issues to inform the design of such interventions, and assess its impact on quality of life and recovery. Methods Mixed methods were used to evaluate 8-week interventions involving weekly group gym-based exercise sessions and nutritional education. Programs were delivered by personal trainers and chefs at a charitable community organization. Acceptability was evaluated using qualitative focus groups and procedural statistics (rates of referral, attendance, and withdrawal). Primary outcomes were quality of life and recovery assessed at baseline and post-intervention; other outcomes included metabolic indicators (weight, waist, blood pressure and fasting glucose, cholesterol, triglycerides) and functional capacity (walk test). Results Of the 100 adults referred, 58 began the program and 38 (66%) completed, attending a median of 75% of sessions. Participants indicated that their appraisal of the program environment (related to venue, social group, and staff), and the realization of benefits, were essential to their experiences with the program. Quality of life (mental health, coping, relationships, senses and self-worth), and recovery (hope) significantly improved. Conclusion Exercise and nutrition interventions have diverse benefits for quality of life and recovery. Programs should be implemented within contexts that promote positive experiences and inclusive social environments to foster self-worth, personal confidence and hope. Recovery-oriented lifestyle interventions should be utilized routinely in mental health care.

Lifetime risk predictions for cardiovascular diseases: Competing risks analyses on a population-based cohort in Sweden

Background and aimsThere are guideline discussions on a lifetime approach to cardiovascular risk. Many of the available risk models estimate the short-term, usually 10-year risk of non-fatal and fatal cardiovascular diseases (CVD) grouped together. We aimed to develop lifetime risk models for non-fatal coronary heart disease, stroke, heart failure and death from CVD and non-CVD. MethodsWe included 92,915 individuals who had participated in a community-based lifestyle intervention programme at 40, 50 and/or 60 years of age. Their collected data on selected risk factors were linked to register data on hospitalizations and death. Parametric multivariable survival regression with a competing risks approach was employed to model cause-specific hazards, which were translated into cumulative incidence functions to provide the risk of experiencing each event separately. All analyses were performed gender-age wise. For illustrative purposes, “better” and “worse” risk profiles were created by setting three modifiable risk factors to the best and worst levels, respectively. ResultsMost of the risk factors qualified for inclusion in the regressions. Men had a higher risk of cardiovascular events and the events occurred at a younger age than women. In the created risk profiles, where serum total cholesterol, smoking status and blood pressure were modified, an excessive number of CVD events were observed in the worse profiles. ConclusionsUsing these models, the lifetime risk of each of the first CVD events can be estimated for different risk factor profiles. Since the predictions are diagnosis specific, the estimates are more accurate.