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

Overview

Journal Lancet Reg Health Eur

Specialty Health Services

Date 2023 Jan 9

PMID 36620354

Authors

Timo A Lakka

Kirsikka Aittola

Elina Jarvela-Reijonen

Tanja Tilles-Tirkkonen

Reija Mannikko

Niina Lintu

Leila Karhunen

Marjukka Kolehmainen

Marja Harjumaa

Elina Mattila

Riia Jarvenpaa

Miikka Ermes

Santtu Mikkonen

Janne Martikainen

Kaisa Poutanen

Ursula Schwab

Pilvikki Absetz

Jaana Lindstrom

Jussi Pihlajamaki

Affiliations

Soon will be listed here.

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, = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, = 971), and a control group receiving usual care (CONTROL, = 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, 2017, and February 28, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, '<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, = 0·028, ' = 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, = 0·033, ' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, = 0·042, ' = 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.

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