Abstract 115: Results of a Twelve Month Randomized Trial of an Internet Based Lifestyle Intervention in High Cardio Metabolic Risk Individuals: The Baptist Employee Healthy Heart Study (BEHHS)

Background: Web-based platforms have been proposed as tools to facilitate lifestyle improvement, however, their efficacy in individuals with high cardiometabolic risk has not been adequately tested. The Baptist Employee Healthy Heart Study (BEHHS) was designed to assess the addition of a personalized, interactive, web-based, lifestyle-management program to the existing health-expertise web platform available to BHSF employees with metabolic syndrome (METS) or type 2 diabetes (DM2) Methods: In this 1:1 randomized, non-blinded trial, the intervention arm was provided access to a web-based personalized and interactive lifestyle program that provided targeted and personalized dietary, weight management and physical activity counseling. The intervention was in addition to access to an online wellness program, a non-interactive website that provided information on healthy diet and physical activity. The control group only had access to the online wellness program. At baseline, each participant had their demographic data collected via questionnaire. At each study visit (baseline, 4 months and 12 months) participants completed questionnaires on lifestyle indices such as diet and physical activity, had their weight, height, waist circumference, body fat (by plethysmography) and blood pressure measured. Laboratory testing was done for traditional lipids and glucose at each visit. Results: Of the 182 participants that were randomized, 163 (82 in the intervention arm and 81 in the control arm) completed the baseline survey and had complete laboratory data at baseline. Loss to follow-up was 12% at 4 months 34% at 12 months. As shown the table, intention to treat analysis using both single imputation (last observation carried forward) and multiple imputation techniques showed no difference in BMI, other measures of adiposity, blood pressure, lipids, physical activity and diet scores. When analyses were restricted to completers alone, no significant change in the results were observed. Conclusion: The addition of web-based, personalized lifestyle program to an already existing lifestyle educational platform did not significantly impact healthy lifestyle promotion and cardiometabolic risk in employees with MetS or DM2.

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An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial (Preprint)

10.2196/preprints.19431 ◽

2020 ◽

Author(s):

Kaarin J Anstey ◽

Nicolas Cherbuin ◽

Sarang Kim ◽

Mitchell McMaster ◽

Catherine D'Este ◽

...

Keyword(s):

Physical Activity ◽

Primary Care ◽

At Risk ◽

General Practice ◽

Risk Reduction ◽

Primary Outcome ◽

Control Group ◽

Web Based ◽

Dementia Risk ◽

Diet And Physical Activity

BACKGROUND There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. OBJECTIVE This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. METHODS A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m2 or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician–led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). RESULTS Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means −3.86, 95% CI −6.81 to −0.90, P=.01; week 18: difference in means −4.05, 95% CI −6.81 to −1.28, P<.001; week 36: difference in means −4.99, 95% CI −8.04 to −1.94, P<.001; and week 62: difference in means −4.62, 95% CI −7.62 to −1.62, P<.001). CONCLUSIONS A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. CLINICALTRIAL Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.

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An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/19431 ◽

2020 ◽

Vol 22 (9) ◽

pp. e19431

Author(s):

Kaarin J Anstey ◽

Nicolas Cherbuin ◽

Sarang Kim ◽

Mitchell McMaster ◽

Catherine D'Este ◽

...

Keyword(s):

Physical Activity ◽

Primary Care ◽

At Risk ◽

General Practice ◽

Risk Reduction ◽

Primary Outcome ◽

Control Group ◽

Web Based ◽

Dementia Risk ◽

Diet And Physical Activity

Background There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. Objective This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. Methods A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m2 or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician–led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). Results Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means −3.86, 95% CI −6.81 to −0.90, P=.01; week 18: difference in means −4.05, 95% CI −6.81 to −1.28, P<.001; week 36: difference in means −4.99, 95% CI −8.04 to −1.94, P<.001; and week 62: difference in means −4.62, 95% CI −7.62 to −1.62, P<.001). Conclusions A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. Trial Registration Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.

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Physical activity in the classroom to prevent childhood obesity: a pilot study in Santiago, Chile

Journal of Nutritional Science ◽

10.1017/jns.2017.14 ◽

2017 ◽

Vol 6 ◽

Cited By ~ 1

Author(s):

Francisco Mardones ◽

Pilar Arnaiz ◽

Johana Soto-Sánchez ◽

Juana Saavedra ◽

Angélica Domínguez ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Pilot Study ◽

Grip Strength ◽

Statistical Power ◽

Physical Activity Intervention ◽

Hand Grip Strength ◽

Control Group ◽

High Waist Circumference ◽

Hand Grip

AbstractThis paper describes a 4-month pilot study that tested the suitability of a physical activity intervention for first graders (children aged 6 and 7 years) in a public school in Santiago, Chile. Teachers were trained to deliver the programme in the classroom during the school day. Teachers were surveyed to determine if this intervention fit within their curriculum and classroom routines and they reported in a focus group that it was suitable for them. All children actively participated in the programme and positive changes in their attitudes towards physical activity were observed by their teachers. Anthropometrics, blood pressure and hand grip strength were measured in the students. A significant reduction was observed in children with high waist circumference ≥ 90th percentile, and in mean systolic blood pressure. However, statistical power values for those comparisons were rather low. Anthropometry and hand grip strength were not modified. The latter calculations and the lack of a control group are showing the weaknesses of this pilot study and that further research with a larger sample size and an experimental design is strongly needed.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Effectiveness of a Primary Care Program to Increase Physical Activity in People With Dementia and Their Family Caregivers (AFISDEMYF Study).

10.21203/rs.3.rs-1058583/v1 ◽

2021 ◽

Author(s):

Elena DE DIOS-RODRIGUEZ ◽

María C PATINO-ALONSO ◽

Susana GONZÁLEZ-SÁNCHEZ ◽

Joana RIPOLL ◽

Olaya TAMAYO-MORALES ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Primary Care ◽

Systolic Blood Pressure ◽

Family Caregivers ◽

Intervention Group ◽

Care Program ◽

Control Group ◽

People With Dementia ◽

The Family

Abstract Aim: To evaluate the effectiveness of an intervention in primary health care designed to increase physical activity in people with dementia and their family caregivers.Methods: A cluster-randomized multicentre clinical trial was carried out.Participants: 140 people with dementia (median age 82 years;63.6% women) and 176 caregivers (median age 62 years ;72.7% women). Seventy patients and 80 caregivers were assigned to the Control Group (CG) and 70 patients and 96 caregivers to the Intervention Group (IG). The physical activity was measured with the pedometer and with the IPAQ-SF questionnaire. The intervention consisted of applying in primary care the program promoting physical activity (PEPAF) for 3 months. The changes observed at 6 months were analyzed. Results:In people with dementia, in the pedometer assessment a decrease was observed in both groups, but it was larger in the CG both in the total number step/day lower in the IG than in the CG and in the aerobic steps / day (52.89 vs -615.93). The activity reported with the IPAQ-SF decreased more in IG, both in the MET/min/week (-258.470 vs -148.23) and in the MVPA min/week. In caregivers the pedometer assessment showed that total steps/day increased more in the IG, as did aerobic steps/day (356.91 vs -12.95). The IPAQ-SF a smaller increase in global activity was declared in the IG than in the CG (545.25 MET/min/week vs 609.55), but the increase in vigorous activity was greater. No differences were found in changes in the functional status and the cognitive performances of people with dementia nor in the mental health in the caregivers, but systolic blood pressure, the Family APGAR and overload in the IG did improve.Conclusions: The results suggest that the intervention carried out may be effective on physical activity in both patients and caregivers. It can also improve systolic blood pressure, the Family APGAR and overload in caregivers. This is the first study to implement a primary care intervention aimed at simultaneously increasing physical activity in people with dementia and their relatives. These results reinforce the importance of using objective measures in clinical trials in people with dementia.Trial registration number: NCT 02044887.

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Abstract P112: Changes in Lifestyle Behavior to Reduce Uncontrolled Blood Pressure in the Faith Trial

Circulation ◽

10.1161/circ.131.suppl_1.p112 ◽

2015 ◽

Vol 131 (suppl_1) ◽

Author(s):

Kristie J Lancaster ◽

Antoinette M Schoenthaler ◽

William Chaplin ◽

Gbenga Ogedegbe

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Medication Adherence ◽

Lifestyle Modification ◽

Intervention Group ◽

Black Americans ◽

Control Group ◽

Lifestyle Behaviors ◽

Uncontrolled Blood Pressure ◽

Faith Based

Introduction: Modifying lifestyle behaviors is a key method for controlling hypertension. This strategy is extremely important for hypertensive Black Americans, as they are more likely to have uncontrolled blood pressure (BP), have a higher risk of complications, and poorer outcomes. To address this need, we conducted a cluster-randomized controlled trial to reduce BP through lifestyle modification that was delivered by lay health advisors in Black churches. The Faith-based Approaches in the Treatment of Hypertension (FAITH) trial was designed to evaluate the effectiveness of a 12-week faith-based lifestyle intervention and subsequent 3-month motivational interviewing vs. health education control on BP reduction among hypertensive Black adults. This study examines the change in lifestyle behaviors during the trial from baseline to 6 months. Methods: We recruited 373 Black Americans with uncontrolled hypertension from 32 urban churches. BP was considered to be uncontrolled if systolic BP (SBP)≥140 mmHg or diastolic BP (DBP)≥90 mmHg, or DBP≥130 mmHg or DBP≥80 mmHg for participants with self-reported diabetes or kidney disease The primary outcome was within-participant change in BP from baseline to 6 months. Lifestyle data collected included the NCI fruit/vegetable intake screener and % calories from fat screener, the International Physical Activity Questionnaire (IPAQ), medication adherence, and measured height and weight. Results: Participants’ mean age was 63.4 y, 76.4% were female, and 96.1% reported being of African descent. The mean BMI was 32.1 kg/m2. At 6 months, the intervention was associated with significant reduction in SBP but not DBP compared with the control group (-16.0 mmHg vs -10.3 mmHg, p=0.017). There was no significant change in number of servings of fruits and vegetables consumed, minutes walked per day, or weight for either group. However, the intervention group had a slight but significantly greater decrease of 1.08 % calories from fat over time compared with the control (p=0.018), but that change was not related to change in SBP. Most notably, there was a significant months x treatment interaction on medication adherence the intervention group had a greater decrease in non-adherence score than the control (-0.84 vs -0.30, p=0.28). This improvement in adherence was related to decrease in SBP (p=0.019). Conclusion: Community-based lifestyle modification program led to significantly reduced systolic BP; and this intervention effect was mediated by improved medication adherence. However, the 12-week intervention resulted in little change in key diet and physical activity behaviors found in other trials to positively affect BP.

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Relationship Between Meeting 24-Hour Movement Guidelines and Cardiometabolic Risk Factors in Children

Journal of Physical Activity and Health ◽

10.1123/jpah.2017-0090 ◽

2017 ◽

Vol 14 (10) ◽

pp. 779-784 ◽

Cited By ~ 19

Author(s):

Peter T. Katzmarzyk ◽

Amanda E. Staiano

Keyword(s):

Physical Activity ◽

Risk Factors ◽

Blood Pressure ◽

Adipose Tissue ◽

Subcutaneous Adipose Tissue ◽

Cardiometabolic Risk ◽

Vigorous Physical Activity ◽

Density Lipoprotein ◽

Cardiometabolic Risk Factors ◽

Subcutaneous Adipose

Background:The purpose of this study was to evaluate the relationship between adherence to pediatric 24-hour movement guidelines (moderate to vigorous physical activity, sedentary behavior, and sleep) and cardiometabolic risk factors.Methods:The sample included 357 white and African American children aged 5–18 years. Physical activity, television viewing, and sleep duration were measured using questionnaires, and the 24-hour movement guidelines were defined as ≥60 minutes per day of moderate to vigorous physical activity on ≥5 days per week, ≤ 2 hours per day of television, and sleeping 9–11 hours per night (ages 5–13 y) or 8–10 hours per night (ages 14–18 y). Waist circumference, body fat, abdominal visceral and subcutaneous adipose tissue, blood pressure, fasting triglycerides, high-density lipoprotein cholesterol, and glucose were measured in a clinical setting.Results:A total of 26.9% of the sample met none of the guidelines, whereas 36.4%, 28.3%, and 8.4% of the sample met 1, 2, or all 3 guidelines, respectively. There were significant associations between the number of guidelines met and body mass index, visceral and subcutaneous adipose tissue, triglycerides, and glucose. There were no associations with blood pressure or high-density lipoprotein cholesterol.Conclusions:Meeting more components of the 24-hour movement guidelines was associated with lower levels of obesity and several cardiometabolic risk factors. Future efforts should consider novel strategies to simultaneously improve physical activity, sedentary time, and sleep in children.

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E-healthcare for diabetes mellitus type 2 patients – a randomised controlled trial in Slovenia

Slovenian Journal of Public Health ◽

10.1515/sjph-2017-0020 ◽

2017 ◽

Vol 56 (3) ◽

pp. 150-157 ◽

Cited By ~ 2

Author(s):

Rade Iljaž ◽

Andrej Brodnik ◽

Tatjana Zrimec ◽

Iztok Cukjati

Keyword(s):

Diabetes Mellitus ◽

Blood Pressure ◽

Nurse Practitioners ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Patients With Diabetes ◽

Randomised Controlled ◽

Interventional Group

Abstract Background Telemonitoring and web-based interventions are increasingly used in primary-care practices in many countries for more effective management of patients with diabetes mellitus (DM). A new approach in treating patients with diabetes mellitus in family practices, based on ICT use and nurse practitioners, has been introduced and evaluated in this study. Method Fifteen Slovene family practices enrolled 120 DM patients treated only with a diet regime and/or tablets into the study. 58 of them were included into the interventional group, and the other 62 DM patients into the control group, within one-year-long interventional, randomised controlled trial. Patients in the control group had conventional care for DM according to Slovenian professional guidelines, while the patients in the interventional group were using also the eDiabetes application. Patients were randomised through a balanced randomisation process. Results Significant reductions of glycated haemoglobin (HbA1c) values were found after 6 and 12 months among patients using this eDiabetes application (p<0.05). Among these patients, a significant correlation was also found between self-monitored blood pressure and the final HbA1c values. Diabetic patients’ involvement in web-based intervention had only transient impact on their functional health status. Conclusion This eDiabetes application was confirmed to be an innovative approach for better self-management of DM type 2 patients not using insulin. Both a significant reduction of HbA1c values and a significant correlation between the average self-measured blood pressure and the final HbA1c values in the interventional group were found. Nurse practitioners – as diabetes care coordinators – could contribute to better adherence in diabetes e-care.

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The Effect of the Mobile ‘Blood Pressure Management Application’ on Hypertension Self-Management Enhancement: A Randomised Controlled Trial

10.21203/rs.2.1820/v2 ◽

2019 ◽

Author(s):

Ali Bozorgi ◽

Hamed Hosseini ◽

Hassan Eftekhar ◽

Reza Majdzadeh ◽

Ali Yoonessi ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Clinical Trial ◽

Repeated Measures ◽

Patient Adherence ◽

Intervention Group ◽

Public Hospitals ◽

Self Management ◽

Control Group ◽

Management Application

Abstract Background : Self-management of blood pressure is of great significance given the increasing incidence of hypertension and associated disabilities. With the increased use of mobile health in medicine, the present study evaluated the effect of the self-management application on patient adherence to hypertension treatment. Methods : This clinical trial was performed on 120 hypertensive patients who were provided with a mobile intervention for 8 weeks and followed-up to 24 th weeks. Data on the primary outcome (adherence to treatment) and secondary outcomes (adherence to the DASH diet, regular monitoring of blood pressure, and physical activity) were collected using a questionnaire and a mobile application, respectively. The inter-group change difference over time was analyzed using repeated measures ANOVA (General Linear Model). Results : The treatment adherence score increased by an average of 5.9 (95%CI: 5.0-6.7) in the intervention group compared to the control group. Scores of adherence to the low-fat and low-salt diet plans were 1.7 (95%CI: 1.3-2.1) and 1.5 (95%CI: 1.2-1.9), respectively. Moreover, moderate physical activity increased to 100.0 minutes (95%CI: 61.7-138.3) per week in the intervention group. Conclusion: The treatment and control of blood pressure require a multifaceted approach given its complexity and multifactorial nature. Considering the widespread use of smartphones , mhealth interventions can be effective in self-management and better patient adherence to treatments. Our results showed that this application can be used as a successful tool for hypertension self-management in patients attending public hospitals in developing countries. Trial registration: This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

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The association of innate and acquired aerobic capacity with resilience in healthy adults: Protocol for an eight-week randomized controlled web-based physical exercise intervention study (Preprint)

10.2196/preprints.29712 ◽

2021 ◽

Author(s):

David Tobias Ochmann ◽

Keito F A Philippi ◽

Peter Zeier ◽

Magdalena Sandner ◽

Barlo Hillen ◽

...

Keyword(s):

Physical Activity ◽

Physical Exercise ◽

Aerobic Capacity ◽

Exercise Intervention ◽

Intervention Group ◽

Control Group ◽

Active Lifestyle ◽

Web Based ◽

Before And After ◽

Physically Inactive

BACKGROUND Physical activity ameliorates chronic stress. Latest research suggests a relation between resilience and physical fitness. Beneficial adaptations of the hypothalamic-pituitary-adrenal axis, the sympathetic nervous system, the endocannabinoid system, and the tryptophan pathway, induced by an active lifestyle, are considered to be resilience conducive. However, detailed knowledge on the molecular link between the effects of acute and chronic physical exercise and an improved resilience is missing. OBJECTIVE Therefore, we implement a human exercise intervention trial addressing the main hypotheses: (1) web-based exercise training improves aerobic capacity of physically inactive adults, which (2) is accompanied by improved resilience. In this setting, we will analyze the relation of resilience parameters with innate and acquired aerobic capacity as well as circulating signaling molecules. METHODS 70 healthy physically inactive (<150min/week physical activity) adults (18-45y) will be randomly assigned to an intervention or control group. Participants in the intervention group receive weekly training utilizing progressive endurance and interval running individually adapted to their training performance via web-based physician support. A standardized incremental treadmill exercise test is performed before and after the intervention period of eight weeks to determine innate and acquired aerobic capacity. Before and after the intervention psychological tests and questionnaires that characterize parameters implicated in resilience (including impulse control, working memory, stress coping, emotion regulation) will be applied. Blood, and saliva will be sampled for analysis of lactate, cortisol, endocannabinoids, catecholamines, kynurenic acid, cell-free DNA and further circulating signal transducers. Statistical analysis will provide comprehensive knowledge on the relation of aerobic capacity and resilience, and furthermore, the capacity of peripheral factors to mediate the promoting effects of exercise on resilience. RESULTS The study was registered in October 2019. Enrollment began in September 2019. Out of 161 subjects, who were initially screened via telefon survey, 43 fulfilled the inclusion criteria and were included. Among the 17 participants in the intervention group, and 14 participants in the control group, who completed the study (total 31), no serious adverse event has been reported. Four participants withdrew during the programm (individual reasons), and 8 participants have not yet completed or begun the program due to the Covid-19 pandemic. Enrollment and data analysis are ongoing, and results are expected to be submitted for publication in October 2021. CONCLUSIONS Our study aims to demonstrate that an increase in physical activity with a simultaneous improvement in aerobic capacity is associated with an increase in resilience. This study design allows to investigate the effect of an active lifestyle on circulating molecular marker levels and their relationship to resilience factors. This will offer novel approaches for the diagnosis of depression and the therapy by exercise prescription. CLINICALTRIAL DRKS00018078, registered October 02, 2019, German Clinical Trials Register. Retrospectively registered: First participant September 10, 2019.

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