TY - JOUR
T1 - Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk
T2 - A stop diabetes pragmatic randomised trial
AU - Lakka, Timo A.
AU - Aittola, Kirsikka
AU - Järvelä-Reijonen, Elina
AU - Tilles-Tirkkonen, Tanja
AU - Männikkö, Reija
AU - Lintu, Niina
AU - Karhunen, Leila
AU - Kolehmainen, Marjukka
AU - Harjumaa, Marja
AU - Mattila, Elina
AU - Järvenpää, Riia
AU - Ermes, Miikka
AU - Mikkonen, Santtu
AU - Martikainen, Janne
AU - Poutanen, Kaisa
AU - Schwab, Ursula
AU - Absetz, Pilvikki
AU - Lindström, Jaana
AU - Pihlajamäki, Jussi
N1 - Funding Information:
STOP DIABETES - from knowledge to solutions project was funded by the Strategic Research Council at the Academy of Finland (http://www.aka.fi/en/about-us/SRC/) in 2016–2019 (303537, 303643, 303644, 303645) and by the Academy of Finland 2020–2023 (T2D-Data project, 332465, 332464, 332466), by the Novo Nordisk Foundation 2018–2020 (33980 and 63753), and by the Finnish Diabetes Research foundation. We acknowledge all health and social care workers in the three participating counties (Hospital district of North Savo, Päijät-Häme and South Karelia) and the stakeholders of the StopDia project (Ministry of Social Affairs and Health, Finnish Social Security Institute Kela, Regional councils of North Savo and Päijät-Häme, Cities of Kuopio, Varkaus, and Siilinjärvi, Ylä-Savon SOTE, Finnish Heart Association, Finnish Diabetes Association, Family Federation of Finland, Association of Finnish Pharmacies, Consumers’ Union of Finland, Etera Mutual Pension Insurance Company, Agency for Rural Affairs Mavi and its partner organisations, Self-care and Digital Value Services project ODA) for participation in planning of the recruitment of the risk individuals and interventions in the StopDia model. We acknowledge Juho Viitasalo and Juha Kekäläinen from the University of Eastern Finland for their extensive work in the development of the StopDia digital tools. We also acknowledge Tiina Laatikainen, Kennet Harald, Markku Peltonen, Pekka Jousilahti, Katri Hemiö, Maliheh Nekouei, Marvi Langari, and Eeva Virtanen from the National Institute for Health and Welfare; Saara Vanhatalo, Johanna Leväsluoto, Adil Umer, Juha Leppänen, Samuli Heinonen, and Eeva Rantala from the Technical Research Centre of Finland VTT; Kari Jalkanen, Suvi Manninen, and Matti Uusitupa from the University of Eastern Finland; and Jaakko Tuomilehto from the University of Helsinki for their role in the development of the StopDia protocols and for participating in the project. We also thank the international advisory board of the StopDia project, including professors Edith Feskens, Theresa Marteau, and Peter Schwarz.
Funding Information:
STOP DIABETES - from knowledge to solutions project was funded by the Strategic Research Council at the Academy of Finland ( http://www.aka.fi/en/about-us/SRC/ ) in 2016–2019 (303537, 303643, 303644, 303645) and by the Academy of Finland 2020–2023 (T2D-Data project, 332465, 332464, 332466), by the Novo Nordisk Foundation 2018–2020 (33980 and 63753), and by the Finnish Diabetes Research foundation. We acknowledge all health and social care workers in the three participating counties (Hospital district of North Savo, Päijät-Häme and South Karelia) and the stakeholders of the StopDia project (Ministry of Social Affairs and Health, Finnish Social Security Institute Kela, Regional councils of North Savo and Päijät-Häme, Cities of Kuopio, Varkaus, and Siilinjärvi, Ylä-Savon SOTE, Finnish Heart Association, Finnish Diabetes Association, Family Federation of Finland, Association of Finnish Pharmacies, Consumers’ Union of Finland, Etera Mutual Pension Insurance Company, Agency for Rural Affairs Mavi and its partner organisations, Self-care and Digital Value Services project ODA) for participation in planning of the recruitment of the risk individuals and interventions in the StopDia model. We acknowledge Juho Viitasalo and Juha Kekäläinen from the University of Eastern Finland for their extensive work in the development of the StopDia digital tools. We also acknowledge Tiina Laatikainen, Kennet Harald, Markku Peltonen, Pekka Jousilahti, Katri Hemiö, Maliheh Nekouei, Marvi Langari, and Eeva Virtanen from the National Institute for Health and Welfare; Saara Vanhatalo, Johanna Leväsluoto, Adil Umer, Juha Leppänen, Samuli Heinonen, and Eeva Rantala from the Technical Research Centre of Finland VTT; Kari Jalkanen, Suvi Manninen, and Matti Uusitupa from the University of Eastern Finland; and Jaakko Tuomilehto from the University of Helsinki for their role in the development of the StopDia protocols and for participating in the project. We also thank the international advisory board of the StopDia project, including professors Edith Feskens, Theresa Marteau, and Peter Schwarz.
Publisher Copyright:
© 2022 The Authors
PY - 2023/1
Y1 - 2023/1
N2 - 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 1st, 2017, and February 28th, 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.
AB - 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 1st, 2017, and February 28th, 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.
KW - Adiposity
KW - Behaviour change
KW - Diet
KW - Digital
KW - eHealth
KW - Habit formation
KW - Insulin resistance
KW - Lifestyle intervention
KW - Nutrition
KW - Physical activity
KW - Prevention
KW - Primary healthcare
KW - Randomised controlled trial
KW - Self-determination theory
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85139861751&partnerID=8YFLogxK
U2 - 10.1016/j.lanepe.2022.100527
DO - 10.1016/j.lanepe.2022.100527
M3 - Article
AN - SCOPUS:85139861751
VL - 24
JO - The Lancet Regional Health - Europe
JF - The Lancet Regional Health - Europe
SN - 2666-7762
M1 - 100527
ER -
