The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress

Raimo Lappalainen, Essi Sairanen, Elina Järvelä, Sanni Rantala, Riitta Korpela, Sampsa Puttonen, Urho M Kujala, Tero Myllymäki, Katri Peuhkuri, Elina Mattila, Kirsikka Kaipainen, Aino Ahtinen, Leila Karhunen, Jussi Pihlajamäki, Heli Järnefelt, Jaana Laitinen, Eija Kutinlahti, Osmo Saarelma, Miikka Ermes, Marjukka Kolehmainen, Raimo Lappalainen, Essi Sairanen, Elina Järvelä, Sanni Rantala, Riitta Korpela, Sampsa Puttonen, Urho M Kujala, Tero Myllymäki, Katri Peuhkuri, Elina Mattila, Kirsikka Kaipainen, Aino Ahtinen, Leila Karhunen, Jussi Pihlajamäki, Heli Järnefelt, Jaana Laitinen, Eija Kutinlahti, Osmo Saarelma, Miikka Ermes, Marjukka Kolehmainen

Abstract

Background: Obesity and stress are among the most common lifestyle-related health problems. Most of the current disease prevention and management models are not satisfactorily cost-effective and hardly reach those who need them the most. Therefore, novel evidence-based controlled interventions are necessary to evaluate models for prevention and treatment based on self-management. This randomized controlled trial examines the effectiveness, applicability, and acceptability of different lifestyle interventions with individuals having symptoms of metabolic syndrome and psychological distress. The offered interventions are based on cognitive behavioral approaches, and are designed for enhancing general well-being and supporting personalized lifestyle changes.

Methods/design: 339 obese individuals reporting stress symptoms were recruited and randomized to either (1) a minimal contact web-guided Cognitive Behavioral Therapy-based (CBT) intervention including an approach of health assessment and coaching methods, (2) a mobile-guided intervention comprising of mindfulness, acceptance and value-based exercises, (3) a face-to-face group intervention using mindfulness, acceptance and value-based approach, or (4) a control group. The participants were measured three times during the study (pre = week 0, post = week 10, and follow-up = week 36). Psychological well-being, lifestyles and habits, eating behaviors, and user experiences were measured using online surveys. Laboratory measurements for physical well-being and general health were performed including e.g. liver function, thyroid glands, kidney function, blood lipids and glucose levels and body composition analysis. In addition, a 3-day ambulatory heart rate and 7-day movement data were collected for analyzing stress, recovery, physical activity, and sleep patterns. Food intake data were collected with a 48 -hour diet recall interview via telephone. Differences in the effects of the interventions would be examined using multiple-group modeling techniques, and effect-size calculations.

Discussion: This study will provide additional knowledge about the effects of three low intensity interventions for improving general well-being among individuals with obesity and stress symptoms. The study will show effects of two technology guided self-help interventions as well as effect of an acceptance and value-based brief group intervention. Those who might benefit from the aforesaid interventions will increase knowledge base to better understand what mechanisms facilitate effects of the interventions.

Trial registration: Current Clinical Trials NCT01738256, Registered 17 August, 2012.

Figures

Figure 1
Figure 1
Flow chart of the study design.
Figure 2
Figure 2
Screenshots of the internet application.
Figure 3
Figure 3
Screenshots of the internet application.
Figure 4
Figure 4
Screenshots of the internet application.
Figure 5
Figure 5
Screenshots of the mobile application. (a) main screen, (b) diary, (c) introduction video, (d) top menu of Mindful Mind, (e) exercise introduction screen, (f) audio exercise, (g) text exercise, (h) exercise reflection screen.

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