Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial

Timo A Lakka; Kirsikka Aittola; Elina Järvelä-Reijonen; Tanja Tilles-Tirkkonen; Reija Männikkö; Niina Lintu; Leila Karhunen; Marjukka Kolehmainen; Marja Harjumaa; Elina Mattila; Riia Järvenpää; Miikka Ermes; Santtu Mikkonen; Janne Martikainen; Kaisa Poutanen; Ursula Schwab; Pilvikki Absetz; Jaana Lindström; Jussi Pihlajamäki

doi:10.1016/j.lanepe.2022.100527

Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial

Lancet Reg Health Eur. 2023 Jan:24:100527. doi: 10.1016/j.lanepe.2022.100527. Epub 2022 Oct 12.

Authors

Timo A Lakka^{1

2

3}, Kirsikka Aittola⁴, Elina Järvelä-Reijonen⁴, Tanja Tilles-Tirkkonen⁴, Reija Männikkö⁴, Niina Lintu¹, Leila Karhunen⁴, Marjukka Kolehmainen⁴, Marja Harjumaa⁵, Elina Mattila⁵, Riia Järvenpää⁶, Miikka Ermes⁵, Santtu Mikkonen^{7

8}, Janne Martikainen⁹, Kaisa Poutanen⁵, Ursula Schwab^{4

10}, Pilvikki Absetz^{4

11}, Jaana Lindström⁶, Jussi Pihlajamäki^{4

10}

Affiliations

¹ Institute of Biomedicine, University of Eastern Finland, Kuopio Campus, Finland.
² Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, Kuopio, Finland.
³ Foundation for Research in Health Exercise and Nutrition, Kuopio Research Institute of Exercise Medicine, Kuopio, Finland.
⁴ Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio Campus, Finland.
⁵ VTT Technical Research Centre of Finland Ltd., Espoo, Finland.
⁶ Department of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.
⁷ Department of Applied Physics, University of Eastern Finland, Kuopio Campus, Finland.
⁸ Department of Environmental and Biological Sciences, University of Eastern Finland, Kuopio Campus, Finland.
⁹ School of Pharmacy, University of Eastern Finland, Kuopio Campus, Finland.
¹⁰ Endocrinology and Clinical Nutrition, Department of Medicine, Kuopio University Hospital, Kuopio Finland.
¹¹ Health Sciences Unit, Faculty of Social Sciences, Tampere University, Tampere, Finland.

Abstract

Background: No real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D).

Methods: We conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18-74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478.

Findings: The 2907 participants assigned were recruited between March 1^st, 2017, and February 28^th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, p'<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, p = 0·028, p' = 0·068) in DIGI+GROUP than in CONTROL. Fasting insulin tended to increase in CONTROL but not in DIGI (1·0 vs. 0·0 mU/L, p = 0·033, p' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, p = 0·042, p' = 0·054). Good adherence to DIGI and DIGI+GROUP (≥median of 501 habits/year in DIGI, ≥5 of all 6 sessions in GROUP) was associated with improved diet quality and good adherence to DIGI with increased physical activity and decreased sedentary time.

Interpretation: A lifestyle intervention based on multiple behaviour change theories and combined digital and group-based face-to-face delivery improves diet quality and tends to decrease abdominal adiposity and prevent an increase in insulin resistance. Good adherence improves the results of the interventions.

Funding: Strategic Research Council at Academy of Finland, Academy of Finland, Novo Nordisk Foundation, and Finnish Diabetes Research foundation.

Keywords: Adiposity; Behaviour change; Diet; Digital; Habit formation; Insulin resistance; Lifestyle intervention; Nutrition; Physical activity; Prevention; Primary healthcare; Randomised controlled trial; Self-determination theory; Type 2 diabetes; eHealth.

Associated data

ClinicalTrials.gov/NCT03156478