Study Design
This study was part of a project to evaluate the occupational health management system of a large, global, private-sector company in Germany from December 2020 to June 2022. The company’s employees received information about the aims of the study and the scope of the evaluation project orally, by email or from brochures. The participants of the WHPP were asked to complete the survey on paper at the start and after completion of the intervention, as well as online at follow-up measurements six and eighteen months after the intervention. Identification of the participants across the four measurement times was achieved by means of an individual pseudonym, which was presented before completing the questionnaires.
The participants of this study were asked to provide their informed consent at the start of the intervention and before completing the online version of the survey at the follow-up stages. This study complied with the company’s data privacy guidelines. The Ethics Committee of the School of Medicine at the Technical University of Munich gave its ethical approval for this study (IRB number: 645/20 S-KH). The study was registered in the German Clinical Trials Register (DRKS00030514).
Intervention Description
The WHPP was developed by a German private-sector company to increase HEPA and HRQOL in employees and was held in-person at a wellness hotel in the district of Hof, Bavaria, Germany. The program of this WHPP was delivered over a period of three weeks by three exercise therapists, a physician and a psychologist, with a maximum of 60 participants per program. The intervention content of the WHPP is reported in accordance with the behaviour change technique taxonomy of Michie et al. (44).
At the start of the WHPP, the physician conducted a 60-minute initial physical examination and consultation to determine the health status and to advise on PA intensity as well as exercise session content in cooperation with the exercise therapist and the participant. Among other things, this medical screening served to inform participants about health consequences and to set personalised participative HEPA behavioural goals for the intervention period. The participants received a printed summary of the physical examination and the goals for HEPA. On the next day, the exercise therapists introduced the participants to the indoor, outdoor and water aerobic exercise facilities in three 90-minute sessions and the participants took part in one 90-minute workshop focusing on the connection between PA and health, which was run by the physician. These sessions provided the participants with instructions and demonstrations of exercise behaviour and basic knowledge of HEPA.
Over the following 15 days, the participants followed a structured program, which comprised a 45-minute running or walking workout in the morning and a 90-minute exercise session after breakfast, both guided by the exercise therapists. The psychologist delivered a 90-minute relaxation technique session or HEPA workshop after lunch. In the evening, the participants could voluntarily spend their leisure-time in the wellness clinic facilities or attend the psychologist’s presentations on the relationship between mental health and PA. The exercise therapists ran guided hiking trips for the participants near the wellness clinic twice a week in the afternoons over the course of the WHPP. There were no sessions on the three Sundays during the WHPP but the training facilities were accessible to all individuals. Participants focused on learning different types of HEPA depending on their personal preferences and medical profile. Furthermore, they received information on the current state of knowledge with respect to biomechanics, behavioural psychology and exercise science. This phase of the WHPP was shaped by the participants’ behavioural practice with respect to HEPA, feedback on HEPA behaviour and instruction to self-monitor HEPA behaviour by the exercise therapists, as well as social support from other participants. This process was supported by the combination of theoretical and practical intervention components as well as by an interprofessional approach, which included HEPA and HRQOL from a psychological, medical and exercise science perspective (45).
In the last week, the physician conducted a second physical examination to screen changes in the participants’ medical profile and to set participative goals for maintaining HEPA after completion of the WHPP. The physicians and exercise therapists gave instructions for the participants’ goal setting and action planning as well as problem solving strategies. Furthermore, the participants refined HEPA behaviour implementation intentions in workshops with the exercise therapist and psychologist on the last two days of the WHPP. This phase of the WHPP focused on transferring HEPA behaviour change into the participants’ daily lives, so that HEPA behaviour could be maintained. The entire curriculum, material overview and WHPP schedule can be accessed by contacting the corresponding author.
Sampling Procedure and Description
Before participants were recruited, the minimum sample size was calculated using a repeated measures within-between interaction analysis of variance design in GPower 3.1 (46). According to this calculation, a sample size of N = 98 was needed to detect an effect of f2 = 0.20 with the statistical power of 1-β = 0.95 and a type one error of p = 0.05 under the assumption of repeated measures correlation of r = 0.50 at four measurement times. This calculation served as the lower threshold for data collection with attrition rates in longitudinal studies ranging from 30 to 70% (47).
During the data collection period, 446 employees took part in the intervention. 387 employees registered their interest to participate in the study. 328 (85%) participants met the first inclusion criterion of being engaged in office work occupation, and 45 (12%) people were ineligible owing to assembly work tasks; a further 14 (4%) were ineligible owing to construction work duties. All 328 participants met the second inclusion criterion, i.e. absence from acute mental or physical disease, and completed the survey at the start of the intervention. In total, 149 (39%) participants completed the survey after the intervention as well as at the first follow-up measurement after six months and the second follow-up measurement after 18 months. A detailed overview of participant enrolment is shown in Figure 2.
Measures
The participants gave information on their sociodemographic status by reporting their gender, age, relationship status and educational level. To assess the primary and secondary outcomes, this study utilised valid and reliable instruments for the population of German adults (32, 48, 49).
The primary outcome of this study was assessed with the PAHCO questionnaire developed by Sudeck and Pfeifer (31); consisting of the three subscales control competence for physical training (CCPT), PA-specific affect regulation (PAAR) and PA-specific self-regulation (PASR), with a total of 13 items rated on a 4-point Likert scale. The first subscale, CCPT (e.g. “If my muscles are tensed up, I know exactly how to counter this through physical activity”), contains six items (Cronbach’s α = 0.86). The second subscale, PAAR (e.g. “I am able to regulate my mood through physical activity”), comprises four items (Cronbach’s α = 0.82). The third subscale, PASR (e.g. “I stick with my plan to do exercise and am not easily distracted from that plan”), comprises three items (Cronbach’s α = 0.84). Mean scores are calculated for the three subscales and for all 13 items of the PAHCO questionnaire, with values ranging from one to four and higher mean scores indicating better PAHCO (Cronbach’s α = 0.92).
The secondary outcome, HEPA, was operationalised with the Godin-Shepard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (50). This questionnaire examines PA during leisure time at light, moderate and vigorous intensities resulting in the cumulative weighted leisure score index (LSI). The values of the LSI start at zero, and values above 24 indicate sufficient leisure-time PA (51).
HRQOL was examined using Short-Form Health Survey (SF-12) version 2.0 (10, 49). SF-12 version 2.0 has a total of twelve items, which examine HRQOL with a weighted and standardised component score in a physical (Cronbach’s α = 0.80) and a mental (Cronbach’s α = 0.86) dimension. For the total score on HRQOL, the mean of the two component scores was calculated. The scores on HRQOL range from zero to 100, with a mean (M) of 50 and a standard deviation (SD) of 10; high values indicate better HRQOL.
Statistical Analysis
The research questions of this study were tested in a per-protocol (PP) analysis, which included all participants that remained within the main study until completion of the follow-up (52). PP analysis serves to investigate the potential efficacy of the intervention for participants who adhere to the study protocol (53), as the research questions addressed the theoretical assumptions of PAHCO and not the effectiveness of the intervention, which is typically analysed by an intention-to-treat approach. Data preparation as well as descriptive and inferential statistical analyses were performed with R and RStudio (Version 4.2.1; RStudio Inc., Boston, MA, USA) (54).
Missing data, for example owing to a partially incomplete survey response, were imputed by applying multivariate-chained equations, when the assumption of data missing at random was met (55). Multivariate outliers were excluded before the analysis, using Mahalanobis distance, based on the recommendations by Tabachnick and Fidell (56). The assumptions of linearity, normality, homoscedasticity and independence of the residuals were examined on the basis of current guidelines for linear regression analyses (57).
Four linear, mixed-model (LMM) regressions, one for the total PAHCO score and three for the PAHCO subscales, were run with the participants’ pseudonym as the random intercept, to test the first research goal of changeability and temporal stability of PAHCO (58). For the second research goal, the secondary outcomes of leisure-time PA and HRQOL were tested separately over the four measurement times, with the three PAHCO subscales as fixed effects and the participants’ pseudonym as a random effect. The measures of HRQOL, leisure-time PA, age, gender, relationship status and educational level served as fixed effects in the LMM regressions.
Standardised estimates (β), confidence intervals (CI 95%) and p-values were examined to determine the influence of the fixed effects on the outcome. The final regression models are presented in comparison with the null model with Akaike’s Information Criteria (AIC), Bayesian Information Criteria (BIC) and adjusted R-squared (R2), on the basis of one imputed data set. Tukey’s post hoc test was used to test the temporal stability of PAHCO and the models’ subscales at the first and second follow-up measurement compared with the level after HEPA intervention completion (59). Standardised estimates of the LMM analyses and post hoc tests were interpreted as small (≈0.10), moderate (≈0.30) or strong effects (≈0.50) (60). On the basis of multiple testing, we adjusted the significance level of the LMM analyses and post hoc testing to p < 0.01 (61).