Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial.

BACKGROUND: Physical inactivity and obesity are global public health challenges. Older adults are important to target for prevention and management of disease and chronic conditions. However, many individuals struggle with maintaining increased physical activity (PA) and improved diet. This feasibility study provides the foundation for the RESTART trial, a randomized controlled trial (RCT) to test a complex intervention to facilitate favourable lifestyle changes older adults can sustain. The primary objective of this study was to investigate study feasibility (recruitment, adherence, side-effects, and logistics) using an interdisciplinary approach. METHODS: This 1-year prospective mixed-method single-arm feasibility study was conducted in Tromsø, Norway, from September 2017. We invited by mail randomly selected participants from the seventh survey of the Tromsø Study (2015-2016) aged 55-75 years with sedentary lifestyle, obesity, and elevated cardiovascular risk. Participants attended a 6-month complex lifestyle intervention program, comprising instructor-led high-intensive exercise and nutritionist- and psychologist-led counselling, followed by a 6-month follow-up. All participants used a Polar activity tracker for daily activity monitoring during the intervention. Participants were interviewed three times throughout the study. Primary outcome was study feasibility measures. RESULTS: We invited potential participants (n=75) by mail of which 27 % (n=20) agreed to participate. Telephone screening excluded four participants, and altogether 16 participants completed baseline screening. The intervention and test procedures of primary and secondary outcomes were feasible and acceptable for the participants. There were no exercise-induced injuries, indicating that the intervention program is safe. Participants experienced that the dietary and psychological counselling were delivered too early in the intervention and in too close proximity to the start of the exercise program. Minor logistic improvements were implemented throughout the intervention period. CONCLUSION: This study indicates that it is feasible to conduct a full-scale RCT of a multi-component randomized intervention trial, based on the model of the present study. No dropouts due to exercise-induced injury indicates that the exercises were safe. While minor improvements in logistics were implemented during the intervention, we will improve recruitment and adherence strategies, rearrange schedule of intervention contents (exercise, diet, and psychology), as well as improve the content of the dietary and behavioural counselling to maximize outcome effects in the RESTART protocol. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03807323 Registered 16 January 2019 - retrospectively registered.

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach.

BACKGROUND: Lack of physical activity (PA) is a risk factor for death and non-communicable disease. Despite this, more than one fourth of adults worldwide do not follow PA guidelines. As part of a feasibility study to test a complex intervention for increasing PA, we included a consumer-based activity tracker (AT) as a tool to measure PA outcomes and to track heart rate during exercise sessions. The aim of the present study was to identify factors that increase wear time when using a consumer-based AT for monitoring of participants in clinical research. METHODS: Sixteen participants aged 55-74 years, with obesity, sedentary lifestyle, and elevated cardiovascular risk were recruited to a 12-month feasibility study. Participants wore a Polar M430 AT to collect continuous PA data during a six-month intervention followed by 6 months of follow-up. We performed quantitative wear time analysis, tested the validity of the AT, and completed two rounds of qualitative interviews to investigate how individual wear-time was linked to participant responses. RESULTS: From 1 year of tracking, mean number of valid wear days were 292 (SD = 86), i.e. 80%. The Polar M430 provides acceptable measurements for total energy expenditure. Motivations for increased wear time were that participants were asked to wear it and the ability to track PA progress. Perceived usefulness included time keeping, heart rate- and sleep tracking, becoming more conscious about day-to-day activity, and improved understanding of which activity types were more effective for energy expenditure. Sources of AT annoyance were measurement inaccuracies and limited instruction for use. Suggestions for improvement were that the AT was big, unattractive, and complicated to use. CONCLUSIONS: Adherence to wearing a consumer-based AT was high. Results indicate that it is feasible to use a consumer-based AT to measure PA over a longer period. Potential success factors for increased wear time includes adequate instruction for AT use, allowing participants to choose different AT designs, and using trackers with accurate measurements. To identify accurate trackers, AT validation studies in the target cohort may be needed. TRIAL REGISTRATION: U.S. National Library of Medicine, Clinical Trial registry: NCT03807323 ; Registered 16 September 2019 - Retrospectively registered.

Patient and public involvement in health research: A Nordic perspective.

Patient and public involvement (PPI) in health research is of increasing interest internationally, as well as being a means to enhance the quality and relevance of research. PPI was one of the main themes and parallel sessions at The Nordic Health Research and Innovation Networks in Oslo in 2017. In this short comment/debate article, we outline some of the experiences from the event. Importantly, there are many common challenges. More collaboration across the borders could ensure a broader range of experience in the field and provide better ways of developing and evaluating PPI in health research.

Motivation and obstacles for weight management among young women - a qualitative study with a public health focus - the Tromsø study: Fit Futures.

BACKGROUND: Due to a worldwide increase in overweight and obesity, weight-management through lifestyle changes has become an important public health issue. Adolescents and young adults comprise a vulnerable group. The transition into adulthood represents a stage in life when establishing good lifestyle habits for the future is important. The aim of this study was to explore motivation and obstacles for weight reduction, weight maintenance and healthy lifestyle choices in young women. METHODS: We conducted semi-structured in depth interviews with 12 young women, both overweight and normal weight, recruited from a school-based population survey. By the use of thematic analysis we searched the interview text for relevant meaning units that emerged as topics that illuminated our research questions. RESULTS: A strong motivation for obtaining or keeping normal weight was clearly present among the participants. Independent of weight-group, the participants described increased levels of physical activity, better eating habits and regularity in daily life as desirable changes. Parents were described as important influencers regarding lifestyle habits. Several participants expressed a need for more information about healthy nutrition and eating. Their motivation for physical activity depended on a positive social setting and elements of joy. The participants described the transition into adulthood including moving out of their parents' home and other structural changes in everyday life, as challenging. It affected their food choices and eating habits and other lifestyle issues. High costs of healthy food and sports activities were frequently mentioned among the obstacles they encountered. CONCLUSION: The results revealed an obvious motivation for lifestyle changes in individuals and environmental challenges for young women in the relevant stage of their life-course. There seems to be a need for health strategies that strengthens individuals' capacity to overcome the environmental challenges in the transition to adulthood. This should include reliable and accessible health education/information regarding healthy nutrition, eating habits, food choices and preparation of meals. Structural initiatives such as easier access to affordable healthy food and less expensive opportunities for physical activity and sports should be considered.

Cross-sectional study of the differences between measured, perceived and desired body size and their relations with self-perceived health in young adults: The Tromsø Study - Fit Futures 2.

AIMS: The aim of this study was to explore the relationships between measured body size (body mass index (BMI)), perceived body size, weight change wishes and self-perceived health in young adults. METHODS: The participants were recruited from a school-based population study in Norway, the Tromsø Study: Fit Futures 2, carried out in 2012-2013. A total of 629 young women and men (aged 18-23 years) reported on the main variables. The data were collected through weight and height measurements and questionnaires. The analyses were performed with descriptive statistics, the χ2 test and Student's t-test. RESULTS: A total of 20% of the women and 28% of the men were overweight or obese. There were considerable discrepancies between the measured BMI and perceived body size in both sexes. A substantial number of participants wanted to change their weight. Among the 174 women who reported that they were trying to lose weight, as many as 57 (32.8%) had a low normal weight (BMI 18.5-21.9 kg/m2). Correspondingly, among the 66 men who reported that they wanted to gain weight, as many as 19 (28.8%) had a high normal weight (BMI 22-24.9 kg/m2). We found no relation between body size perceptions, weight change wishes and self-perceived health. CONCLUSIONS: Discrepancies between measured and perceived body size and weight change wishes are common findings in young adults. The lack of relation with self-perceived health found in our study is surprising and not easy to interpret. To gain more knowledge about these matters, further research, including both qualitative and quantitative studies, is needed.

Overweight and obesity in young adult women: A matter of health or appearance? The Tromsø study: Fit futures.

With the increasing number of overweight and obese people, there is a growing public health concern and focus on body size and lifestyle issues, especially in the media. Young adult women comprise a vulnerable group regarding issues of weight balance and appearance. The aim of the study was to examine the experiences of young women on how this focus influences their attitudes concerning weight changes, appearance, and health. We conducted 12 interviews with young women from two different weight groups about the attention on overweight issues. The results from the in-depth interviews were scrutinized through content analyses. The main findings indicate that young women experience a considerable focus on overweight issues with a trend towards appearance rather than health. Overweight and obesity are sensitive topics, and participants expressed strong views on the cultural definitions of normal body size and appearance. The squeeze between cultural norms and young women's perceptions of their own body and health was described as a possible negative factor influencing well-being as well as motivation for lifestyle changes. A more relaxed focus on overweight issues and especially on appearance is necessary when addressing weight-balance issues and lifestyle changes in young adult women.