Health Economic Evaluation of a Controlled Lifestyle Intervention: The Healthy Lifestyle Community Program (Cohort 2; HLCP-2).

Non-communicable diseases (NCD) are associated with high costs for healthcare systems. We evaluated changes in total costs, comprising direct and indirect costs, due to a 24-month non-randomized, controlled lifestyle intervention trial with six measurement time points aiming to improve the risk profile for NCDs. Overall, 187 individuals from the general population aged ≥18 years were assigned to either the intervention group (IG; n = 112), receiving a 10-week intensive lifestyle intervention focusing on a healthy, plant-based diet; physical activity; stress management; and community support, followed by a 22-month follow-up phase including monthly seminars, or a control group (CG; n = 75) without intervention. The complete data sets of 118 participants (IG: n = 79; CG: n = 39) were analyzed. At baseline, total costs per person amounted to 67.80 ± 69.17 EUR in the IG and 48.73 ± 54.41 EUR in the CG per week. The reduction in total costs was significantly greater in the IG compared to the CG after 10 weeks (p = 0.012) and 6 months (p = 0.004), whereas direct costs differed significantly after 10 weeks (p = 0.017), 6 months (p = 0.041) and 12 months (p = 0.012) between the groups. The HLCP-2 was able to reduce health-related economic costs, primarily due to the reduction in direct costs.

The healthful plant-based diet index as a tool for obesity prevention-The healthy lifestyle community program cohort 3 study.

Background: World-wide the prevalence of obesity is high, and promoting a shift toward more healthful and more plant-based dietary patterns appears to be one promising strategy to address this issue. A dietary score to assess adherence to a healthy plant-based diet is the healthful plant-based diet index. While there is evidence from cohort studies that an increased healthful plant-based diet index is associated with improved risk markers, evidence from intervention studies is still lacking. Methods: A lifestyle intervention was conducted with mostly middle-aged and elderly participants from the general population (n = 115). The intervention consisted of a 16-month lifestyle program focusing on a healthy plant-based diet, physical activity, stress management, and community support. Results: After 10 weeks, significant improvements were seen in dietary quality, body weight, body mass index, waist circumference, total cholesterol, measured and calculated low-density lipoprotein (LDL) cholesterol, oxidized LDL particles, non-high-density lipoprotein cholesterol, remnant cholesterol, glucose, insulin, blood pressure, and pulse pressure. After 16 months, significant decreases were seen in body weight (-1.8 kg), body mass index (-0.6 kg/m2), and measured LDL cholesterol (-12 mg/dl). Increases in the healthful plant-based diet index were associated with risk marker improvements. Conclusions: The recommendation of moving toward a plant-based diet appears acceptable and actionable and may improve body weight. The healthful plant-based diet index can be a useful parameter for intervention studies.

Effects of the healthy lifestyle community program (cohort 1) on stress-eating and weight change after 8 weeks: a controlled study.

Stress-eating (eating more or more unhealthily in order to accommodate to stress), contributes to the development and maintenance of obesity. The effect of comprehensive weight loss interventions on changes in stress-eating as well as the contributing role of stress-eating on weight reduction has not been examined. The impact of the 8-week intensive phase of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on emotional, external and restrained eating, as expressions of stress-eating was evaluated in a non-randomized controlled trial. Intervention: 14 seminars (twice per week, including practical units), complemented by stress-regulation and cooking workshops and coaching sessions empowering participants to change their behaviour towards a healthy plant-based diet (ad libitum), stress regulation, regular exercise and to focus on social support. Participants were recruited from the general population. In the intervention group, 91 participants (IG; age: 56 ± 10, 77% female) and in the control group, 52 (CG; age: 62 ± 14, 57% female) were enrolled. At baseline, participants of the IG reported higher levels of stress (9.7 ± 5.4 points [P] vs. 7.6 ± 6.2; p < 0.011), and of emotional eating (27.9 ± 9.4 vs. 20.0 ± 7.1; p < 0.001) and external eating (29.1 ± 4.9 vs. 25.5 ± 5.6; p < 0.001) than participants of the CG. Within 8 weeks, in the IG, scores of emotional eating (- 3.5 ± 5.4 P) and external eating significantly decreased (= - 2.0 ± 3.8 P), while restrained eating increased (2.7 ± 5.0 P; p for all < 0.001). Weight change was negatively correlated with change of external eating (R2 = 0.045; CC = - 0.285; p = 0.014), indicating that a greater weight change was associated with a smaller change of external eating. This is the first study to prospectively investigate the role of stress-eating on the weight reduction effect of comprehensive lifestyle interventions. Our data confirm that overweight is associated with EE and external eating and suggest that the HLCP is capable to reduce both, weight and stress-eating.Trial registration: German Clinical Trials Register (DRKS; reference: DRKS00018821; September 18th 2019; retrospectively registered).

Effect of a controlled lifestyle intervention on medication use and costs: The Healthy Lifestyle Community Program (cohort 2).

TRIAL REGISTRATION: German Clinical Trials Register DRKS (www.drks.de; reference: DRKS00018775).

Exploratory analysis of the effect of a controlled lifestyle intervention on inflammatory markers - the Healthy Lifestyle Community Programme (cohort 2).

BACKGROUND: Chronic low-grade inflammation is associated with an increased risk of chronic disease and mortality. The objective of the study was to test the effect of a healthy lifestyle intervention on biomarkers of inflammation (among other risk markers). METHODS: We conducted a non-randomized controlled trial with mostly middle-aged and elderly participants from the general population in rural northwest Germany (intervention: n = 114; control: n = 87). The intervention consisted of a 1-year lifestyle programme focusing on diet (largely plant-based; strongest emphasis), physical activity, stress management, and social support. High-sensitivity C-reactive protein (hs-CRP) was assessed at baseline, 10 weeks, 6 months, and 1 year. Homocysteine (Hcy) was assessed at baseline, 10 weeks, and 1 year. Adiponectin (Apn) was assessed at baseline and 10 weeks. An exploratory analysis of these inflammatory markers assessing the between-group differences with ANCOVA was conducted. RESULTS: The 1-year trajectory of hs-CRP was significantly lower in the intervention group compared to control (between-group difference: -0.8 (95% CI -1.2, -0.3) mg/l; p = 0.001; adjusted for baseline). The 1-year trajectory of Hcy was non-significantly higher in the intervention compared to control (between-group difference: 0.2 (95% CI -0.3, 0.7) µmol/l; p = 0.439; adjusted for baseline). From baseline to 10 weeks, Apn decreased significantly more in the intervention group compared to control (between-group difference: -1.6 (95% CI -2.7, -0.5) µg/ml; p = 0.004; adjusted for baseline). CONCLUSIONS: Our study shows that healthy lifestyle changes can lower hs-CRP and Apn levels and are unlikely to significantly affect Hcy levels within 1 year. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; reference: DRKS00018775 , registered 12 Sept 2019; retrospectively registered; www.drks.de ).

Eight Weeks of Lifestyle Change: What are the Effects of the Healthy Lifestyle Community Programme (Cohort 1) on Cortisol Awakening Response (CAR) and Perceived Stress?

Background: Stress and cortisol dysregulation are linked to NCDs. Moreover, stress favours unhealthy lifestyle patterns, which increase the risk for NCDs. The role of the Cortisol Awakening Response (CAR) and the effect of lifestyle interventions on the same remain unclear. Methods: The impact of the intensive 8-week phase of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on parameters of the CAR, ie cortisol values 0 (sample [S]1), 30), 45 and 60 minutes post-awakening, average peak, S1-peak delta and area under the increase curve (AUCI), and perceived stress levels (PSL) was evaluated in a non-randomized, controlled trial. Covariates of the CAR (eg sleep measures) and irregularities in sampling were assessed. The intervention focussed on stress management, a healthy diet, regular exercise, and social support. Participants were recruited from the general population. Multiple linear regression analyses were conducted. Results: 97 participants (age: 56 ± 10 years; 71% female), with 68 in the intervention group (IG; age: 55 ± 8, 77% female) and 29 participants in the control group (CG; age: 59 ± 12, 59% female), were included in the analysis. The baseline characteristics of both groups were comparable, except participants of IG were younger. On average, the PSL at baseline was low in both groups (IG: 9.7 ± 5.4 points; CG: 8.5 ± 6.9 points; p = .165), but 22% (n = 15) in the IG and 20% (n = 6) in the CG reported a high PSL. Most participants reported irregularities in CAR sampling, eg interruption of sleep (IG: 80% CG: 81%). After 8 weeks, most CAR parameters and the PSL decreased in the IG and CG, resulting in no differences of change between the groups. In the IG only, a decrease of PSL was linked to an increase of CAR parameters, eg AUCI (correlation coefficient = -0.307; p = .017). Conclusion: The HLCP may potentially reduce PSL and change the CAR, but results cannot be clearly attributed to the programme. Methodological challenges and multiple confounders, limit suitability of the CAR in the context of lifestyle interventions. Other measures (eg hair-cortisol) may give further insights. Trial registration: German Clinical Trials Register (DRKS); DRKS00018821; www.drks.de.

Bridging the gap between science and society: long-term effects of the Healthy Lifestyle Community Programme (HLCP, cohort 1) on weight and the metabolic risk profile: a controlled study.

Background: The potential of adopting a healthy lifestyle to fight non-communicable diseases (NCDs) is not fully used. We hypothesised that the Healthy Lifestyle Community Programme (HLCP, cohort 1) reduces weight and other risk markers compared with baseline and control. Methods: 24-month, non-randomised, controlled intervention trial. Intervention: intensive 8-week phase with seminars, workshops and coaching focusing on a healthy lifestyle (eg, plant-based diet, physical activity, stress management) and group support followed by a 22-month alumni phase. Weight reduction as the primary outcome and other NCD risk parameters were assessed at six time points. Participants were recruited from the general population. Multiple linear regression analyses were conducted. Results: 143 participants (58±12 years, 71% female) were enrolled (91 in the intervention (IG) and 52 in the control group (CG)). Groups' baseline characteristics were comparable, except participants of IG were younger, more often females, overweight and reported lower energy intake (kcal/day). Weight significantly decreased in IG at all follow-ups by -1.5 ± 1.9 kg after 8 weeks to -1.9 ± 4.0 kg after 24 months and more than in CG (except after 24 months). Being male, in the IG or overweight at baseline and having a university degree predicted more weight loss. After the intervention, there were more participants in the IG with a 'high' adherence (+12%) to plant-based food patterns. The change of other risk parameters was most distinct after 8 weeks and in people at elevated risk. Diabetes-related risk parameters did not improve. Conclusion: The HLCP was able to reduce weight and to improve aspects of the NCD risk profile. Weight loss in the IG was moderate but maintained for 24 months. Participants of lower educational status might benefit from even more practical units. Future interventions should aim to include more participants at higher risk. Trial registration number: DRKS00018821.

Healthy lifestyle changes favourably affect common carotid intima-media thickness: the Healthy Lifestyle Community Programme (cohort 2).

Common carotid intima-media thickness (ccIMT) progression is a risk marker for cardiovascular disease (CVD), whereas healthy lifestyle habits are associated with lower ccIMT. The objective of the present study was to test whether a healthy lifestyle intervention can beneficially affect ccIMT progression. A community-based non-randomised, controlled lifestyle intervention was conducted, focusing on a predominantly plant-based diet (strongest emphasis), physical activity, stress management and social health. Assessments of ccIMT were made at baseline, 6 months and 1 year. Participants had an average age of 57 years and were recruited from the general population in rural northwest Germany (intervention: n 114; control: n 87). From baseline to 1 year, mean ccIMT significantly increased in both the intervention (0⋅026 [95 % CI 0⋅012, 0⋅039] mm) and control group (0⋅045 [95 % CI 0⋅033, 0⋅056] mm). The 1-year trajectory of mean ccIMT was lower in the intervention group (P = 0⋅022; adjusted for baseline). In a subgroup analysis with participants with high baseline mean ccIMT (≥0⋅800 mm), mean ccIMT non-significantly decreased in the intervention group (-0⋅016 [95 % CI -0⋅050, 0⋅017] mm; n 18) and significantly increased in the control group (0⋅065 [95 % CI 0⋅033, 0⋅096] mm; n 12). In the subgroup, the 1-year trajectory of mean ccIMT was significantly lower in the intervention group (between-group difference: -0⋅051 [95 % CI -0⋅075, -0⋅027] mm; P < 0⋅001; adjusted for baseline). The results indicate that healthy lifestyle changes may beneficially affect ccIMT within 1 year, particularly if baseline ccIMT is high.

Effect of a 1-Year Controlled Lifestyle Intervention on Body Weight and Other Risk Markers (the Healthy Lifestyle Community Programme, Cohort 2).

INTRODUCTION: The prevalence of obesity is high and increasing worldwide. Obesity is generally associated with an increased risk of chronic disease and mortality. The objective of the study was to test the effect of a lifestyle intervention on body weight and other chronic disease risk markers. METHODS: A non-randomized controlled trial was conducted, including mostly middle-aged and elderly participants recruited from the general population in rural northwest Germany (intervention: n = 114; control: n = 87). The intervention consisted of a 1-year lifestyle programme, focussing on four key areas: a largely plant-based diet (strongest emphasis), physical activity, stress management, and community support. Parameters were assessed at baseline, 10 weeks, 6 months, and 1 year. The control group received no intervention. RESULTS: Compared to the control, in the intervention group, significantly lower 1-year trajectories were observed for body weight, body mass index (BMI), waist circumference (WC), total cholesterol, calculated LDL cholesterol, non-HDL cholesterol, remnant cholesterol (REM-C), glucose, HbA1c, and resting heart rate (RHR). However, between-group differences at 1 year were small for glucose, HbA1c, and cholesterol (apart from REM-C). No significant between-group differences were found for 1-year trajectories of measured LDL cholesterol, HDL cholesterol, triglycerides, insulin, blood pressure, and pulse pressure. CONCLUSION: The intervention successfully reduced body weight, BMI, WC, REM-C, and RHR. However, at 1 year, effectiveness of the intervention regarding other risk markers was either very modest or could not be shown.