Effects of a Web-Based Lifestyle Intervention on Physical Fitness and Health in Physically Inactive Adults: A Randomized Controlled Trial.

Web-based lifestyle interventions are a new area of health research. This randomized controlled trial evaluated the effectiveness of an interactive web-based health program on physical fitness and health. N = 189 healthy adults participated in a 12-week interactive (intervention) or non-interactive (control) web-based health program. The intervention provided a web-based lifestyle intervention to promote physical activity and fitness through individualized activities as part of a fully automated, multimodal health program. The control intervention included health information. Cardiorespiratory fitness measured as maximum oxygen uptake (VO2max) was the primary outcome, while musculoskeletal fitness, physical activity and dietary behavior, and physiological health outcomes were assessed as secondary outcomes (t0: 0 months, t1: 3 months, t2: 9 months, t3: 15 months). Statistical analysis was performed with robust linear mixed models. There were significant time effects in the primary outcome (VO2max) (t0-t1: p = 0.018) and individual secondary outcomes for the interactive web-based health program, but no significant interaction effects in any of the outcomes between the interactive and non-interactive web-based health program. This study did not demonstrate the effectiveness of an interactive compared with a non-interactive web-based health program in physically inactive adults. Future research should further develop the evidence on web-based lifestyle interventions.

Effects of a Web-Based Lifestyle Intervention on Weight Loss and Cardiometabolic Risk Factors in Adults With Overweight and Obesity: Randomized Controlled Clinical Trial.

BACKGROUND: The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. OBJECTIVE: The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. METHODS: The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. RESULTS: The intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. CONCLUSIONS: The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph19031393.

Evaluation of an Interactive Web-Based Health Program for Weight Loss-A Randomized Controlled Trial.

Personal behavior patterns, such as unhealthy diet and lack of physical activity, lead to the development of overweight and obesity. These are associated with other comorbidities, reduced quality of life, premature frailty and increased mortality. Personalized web-based interventions are promising in inducing behavioral change leading to effective reductions in body weight at relatively low costs. However, the long-term effects have not been thoroughly investigated. This work evaluates the effectiveness of web-based interactive weight loss coaching and compares it to a non-interactive web-based health program. Therefore, a randomized controlled trial (RCT) was implemented, measuring primary and secondary outcomes at four time points (program start; end of the 12-week-program; 6 months after program end, 12 months after program end). The net sample covered 1499 subjects in the intervention group and 1492 in the control group. On average, the IG was 43 years old (±13.6), 80.1% male, and had 86.4 kg body weight (±16.1) at baseline. The CG was 42.7 years old (±13.9), 79.5% male and had a mean body weight of 86.1 (±15.7). Multilevel analyses with fixed effects were carried out both from the perspective of an intention-to-treat (ITT) and a complete cases approach (CCA). In sum, our adjusted models suggest a weight loss of 0.4 kg per time point. At the end of the program, significant differences in weight loss in % to baseline (delta M = 1.8 in the CCA) were observed in favor of the intervention group. From a long-term perspective, no superiority of the intervention group in comparison to the control group could be found. More intensive use of the program was not statistically associated with higher weight loss.

Effects of a 12-Week Web-Based Weight Loss Program for Adults With Overweight and Obesity on COVIDAge and Lifestyle-Related Cardiometabolic Risk Factors: A Randomized Controlled Trial.

The coronavirus disease 2019 (COVID-19) pandemic has induced unhealthy lifestyles, particularly an increase in overweight and obesity, which have been shown to be associated with an increased risk of unfavorable COVID-19 outcomes. Web-based health programs could be a helpful measure, especially in times of severe restrictions. Therefore, the present study aimed to investigate the effects of regular attendance in a 12-week web-based weight loss program on COVIDAge, a new construct for risk assessment of COVID-19, and lifestyle-related cardiometabolic risk factors. N = 92 subjects with overweight and obesity (50.0 ± 10.8 years, 76.1% females, 30.5 ± 2.1 kg/m2) of this randomized controlled trial, which were assigned to an interactive (ONLINE: intervention group) or non-interactive (CON: control group) web-based weight loss program, were included in the data analysis. COVIDAge and cardiometabolic risk factors, including anthropometric outcomes, blood pressure, flow-mediated dilatation, and blood parameters, were assessed before and after the 12-week intervention phase. There was a significant group difference in the change of COVIDAge (ONLINE: -4.2%, CON: -1.3%, p = 0.037). The ONLINE group also showed significantly greater reductions in anthropometric outcomes and systolic blood pressure than the CON group (p < 0.05). To the authors' knowledge, this was the first study investigating the effects of regular attendance in a web-based health program on lifestyle-related risk factors for COVID-19. The results demonstrated that adults with overweight and obesity can improve their COVIDAge and specific cardiometabolic risk factors by using this interactive web-based weight loss program regularly. However, this needs to be confirmed by future studies. This study is registered at the German Clinical Trials Register (DRKS00020249, https://www.drks.de).

Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials.

Web-based lifestyle interventions have attracted considerable research interest. Available evidence on such interventions suggests health-promoting effects, but further research is needed. Therefore, this study aims to investigate short-, medium-, and long-term health effects of a web-based health program ("TK-HealthCoach", TK-HC) offered by a national statutory health insurance fund (Techniker Krankenkasse, TK). The study comprises two randomized controlled clinical trials to evaluate the health goals "Increasing Fitness" (Fclin) and "Losing and Maintaining Weight" (Wclin). A total of n = 186 physically inactive (Fclin) and n = 150 overweight or obese (Wclin) adults will be randomly assigned to a 12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio. Primary outcomes include cardiorespiratory fitness (Fclin) and body weight (Wclin). Secondary outcomes comprise musculoskeletal fitness (Fclin), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (Fclin, Wclin). All outcomes will be measured before and after the 12-week intervention and after a 6- and 12-month follow-up. Additionally, usage behavior data on the health programs will be assessed. Linear mixed models (LMMs) will be used for statistical analysis. Findings of this study will expand the available evidence on web-based lifestyle interventions.

A questionnaire to assess eating behavior: Structure, validity and responsiveness of a new German eating behavior scale (SEV).

Numerous weight-loss interventions promoting healthy and weight-reducing eating behavior have been developed over the past years. To evaluate the effectiveness of such interventions for eating behavior change, short, validated and sensitive instruments are needed. In this study series, we developed and validated a new outcome measure to assess health-conscious and weight-controlling eating behavior for the evaluation of weight-loss interventions. The preliminary version of the German eating behavior scale (Skala zumErnährungsverhalten [SEV]) included 40 items. Three studies were conducted to (a) reduce the preliminary item pool, (b) investigate structural validity and internal consistency using exploratory and confirmatory factor analyses (EFA, CFA), as well as McDonald's ω, and (c) test construct validity with physiological and behavioral parameters. Responsiveness to change was also assessed after a 12-week weight-loss intervention. EFA indicated a two-factor solution with health-conscious (hc-EB) and weight-controlling eating behavior (wc-EB) as subscales, CFA confirmed the two-factor solution with acceptable model fit. Internal consistencies of both subscales were also acceptable to good (hc-EB: ω = 0.88; wc-EB: ω = 0.78). Significantly small to moderate correlations to the Healthy Eating Index (r = 0.51) as well as blood glucose (r = 0.31), blood lipids (r = 0.23), and vascular age (r = 0.31) were found, supporting the construct validity of the SEV and its subscales. Both subscales detected intervention-related changes in eating behavior among subjects of a weight-loss intervention with Standardized Response Means of 0.52 and 0.67, indicating good responsiveness of the SEV. In sum, findings provide evidence that the SEV is a valid and responsive measure to assess health-conscious and weight-controlling eating behavior.

Effects of a Web-Based Weight Loss Program on the Healthy Eating Index-NVS in Adults with Overweight or Obesity and the Association with Dietary, Anthropometric and Cardiometabolic Variables: A Randomized Controlled Clinical Trial.

This randomized, controlled clinical trial examined the impact of a web-based weight loss intervention on diet quality. Furthermore, it was investigated whether corresponding changes in diet quality were associated with changes in measures of cardiovascular risk profile. Individuals with a body mass index (BMI) of 27.5 to 34.9 kg/m2 and an age of 18 to 65 y were assigned to either an interactive and fully automated web-based weight loss program focusing on dietary energy density (intervention) or a non-interactive web-based weight loss program (control). Examinations were performed at baseline (t0), after the 12-week web-based intervention (t1), and after an additional 6 (t2) and 12 months (t3). Based on a dietary record, the Healthy Eating Index-NVS (HEI-NVS) was calculated and analyzed using a robust linear mixed model. In addition, bootstrapped correlations were performed independently of study group to examine associations between change in HEI-NVS and change in dietary, anthropometric, and cardiometabolic variables. A total of n = 153 participants with a mean BMI of 30.71 kg/m2 (SD 2.13) and an average age of 48.92 y (SD 11.17) were included in the study. HEI-NVS improved significantly in the intervention group from baseline (t0) to t2 (p = 0.003) and to t3 (p = 0.037), whereby the course was significantly different up to t2 (p = 0.013) and not significantly different up to t3 (p = 0.054) compared to the control group. Independent of study group, there was a significant negative association between change in HEI-NVS and dietary energy density. A higher total score in HEI-NVS did not correlate with improvements in cardiovascular risk profile. The interactive and fully automated web-based weight loss program improved diet quality. Independent of study group, changes in HEI-NVS correlated with changes in energy density, but there was no association between improvements in HEI-NVS and improvements in cardiovascular risk profile.

Effectiveness of an interactive web-based health program for adults: a study protocol for three concurrent controlled-randomized trials (EVA-TK-Coach).

BACKGROUND: A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achieving their health goals of Increasing Fitness, Losing and Maintaining Weight, or Smoking Cessation. METHODS: The aim of this study is to test the long-term effectiveness of the web-based TK-HealthCoach with regard to the primary outcomes of increased physical activity, sustainable weight reduction, and smoking abstinence. We are conducting three interconnected, randomized controlled trials (RCT), one for each health goal, within which participants are allocated to an intervention group (interactive online health program) or a control group (non-interactive online health program). The effects of the intervention groups compared to the control groups will be analyzed by multi-level models for change. Participants' data are captured via online questionnaires before the program starts (baseline t0), again when it ends (t1), and later at two follow-up surveys (t2 and t3); the latter 12 months after t1. We are documenting socio-demographic, health-related, and psychological variables as well as usage behavior data of the programs. According to our sample size calculation, we have to enroll 1114 participants in each Losing and Maintaining Weight and Increasing Fitness RCT and 339 participants in the Smoking Cessation RCT. Additionally, 15-20 participants in the interactive smoking-cessation program will be invited to qualitative telephone interviews with the aim to obtain detailed information concerning utilization, compliance, and satisfaction. The online RCTs' inclusion criteria are: adults of each gender regardless of whether they are insured with Techniker health insurance fund. Persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Specific exclusion criteria apply to each program/RCT. DISCUSSION: We assume that study participants will improve their health behavior by using the offered online health programs and that each health goal's intervention group will reveal advantages regarding the outcome variables compared to the control groups. Study enrollment started on January 1, 2020. TRIAL REGISTRATION: German Clinical Trials Register, Universal Trial Number (UTN): U1111-1245-0273 . Registered on 11 December 2019.

The Influence of Specific Bioactive Collagen Peptides on Knee Joint Discomfort in Young Physically Active Adults: A Randomized Controlled Trial.

First evidence indicates that the supplementation of specific collagen peptides is associated with a significant reduction in activity-related joint pain in young adults. The purpose of the current investigation was to confirm the efficacy of the same collagen peptides in a comparable study population. In total, 180 active men and women aged between 18 and 30 years with exercise-related knee pain but no diagnosed joint disease completed the trial over a period of 12 weeks. Participants were randomly assigned to the group receiving 5 g of specific collagen peptides (CP-G) or to the placebo group (P-G). For the primary outcome, changes in pain during or after exercise from pre- to post-intervention were assessed by the participants using the Visual Analog Scale (VAS). These changes were additionally evaluated by the examining physician by means of anamnesis and physical examination of the affected knee joint. As secondary outcomes, pain under resting conditions and after 20 squats were compared between the study groups. In addition, the mobility of the knee joint and the use of alternative therapies (e.g., ointments or physiotherapy) were recorded. The supplementation of specific collagen peptides derived from type I collagen with a mean molecular weight of 3 kDa led to a significantly (p = 0.024) higher reduction of exercise-induced knee pain (-21.9 ± 18.3 mm) compared with the placebo group (-15.6 ± 18.5 mm). These findings were consistent with the physician's evaluation (-23.0 ± 19.2 mm vs. -14.6 ± 17.9 mm, p = 0.003). The decrease in pain under resting conditions and after squats did not significantly differ between the groups, as only a small number of participants suffered from pain under these conditions. Due to the clinically unremarkable baseline values, the mobility of the knee joint did not change significantly after the intervention. In conclusion, the current investigation confirmed that the oral intake of bioactive collagen peptides used in the current investigation led to a statistically significant reduction of activity-related joint pain in young active adults suffering from knee joint discomfort.

Effects of Incentives on Adherence to a Web-Based Intervention Promoting Physical Activity: Naturalistic Study.

BACKGROUND: Despite many advantages of web-based health behavior interventions such as wide accessibility or low costs, these interventions are often accompanied by high attrition rates, particularly in usage under real-life conditions. It would therefore be helpful to implement strategies such as the use of financial incentives to motivate program participation and increase adherence. OBJECTIVE: This naturalistic study examined real-life usage data of a 12-week web-based physical activity (PA) intervention (Fitness Coach) among insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group). Users in the incentive group had the perspective of receiving €30 (about US $33) cash back at the end of the intervention. METHODS: Registration and real-life usage data as part of routine data management and evaluation of the Fitness Coach were analyzed between September 2016 and June 2018. Depending on the duration of use and the weekly recording of tasks, 4 adherence groups (low, occasional, strong, and complete adherence) were defined. Demographic characteristics were collected by a self-reported questionnaire at registration. We analyzed baseline predictors and moderators of complete adherence such as participation in the program, age, gender, and BMI using binary logistic regressions. RESULTS: A total of 18,613 eligible persons registered for the intervention. Of these, 15,482 users chose to participate in the incentive program (incentive group): mean age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m2, median (IQR) BMI 23.8 (21.7-26.4) kg/m2; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group): mean age 40.7 (SD 13.4) years, mean BMI 26.2 (SD 5.0) kg/m2, median BMI 25.3 (IQR 22.6-28.7) kg/m2; 72.18% (2260/3131) female. At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group. Gender significantly moderated the effect with men in the incentive group showing higher odds to be completely adherent than women overall and men in the nonincentive group (OR 1.761). Furthermore, older age and male gender were significant predictors of complete adherence for all participants, whereas BMI did not predict intervention completion. CONCLUSIONS: This is the first naturalistic study in the field of web-based PA interventions that shows the potential of even small financial incentives to increase program adherence. Male users, in particular, seem to be strongly motivated by incentives to complete the intervention. Based on these findings, health care providers can use differentiated incentive systems to increase regular participation in web-based PA interventions.