Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.
Marja Harjumaa, Pilvikki Absetz, Miikka Ermes...
https://pubmed.ncbi.nlm.nih.gov/32779571/Actively Recruiting
Led by University of Eastern Finland · Updated on 2017-05-17
10000
Participants Needed
1
Research Sites
991 weeks
Total Duration
Researchers are evaluating new ways to identify people at higher risk of type 2 diabetes and help them adopt and maintain healthier lifestyles. This study combines strategies targeting both conscious decisions and automatic behaviors to improve diet, physical activity, and weight management. It also aims to understand societal challenges and supports for healthy living, involving health care, third sector, and community actors. The study will follow 10,000 adults aged 18 to 70 years at increased diabetes risk over a one-year randomized controlled trial and long-term follow-up. Participants will be randomly assigned to one of three groups a control group receiving digital information about healthy diet and physical activity, a digital lifestyle intervention group using a specially developed self-help digital tool for 12 months, or a combined group receiving both the digital tool and six face-to-face group coaching sessions led by trained nurses. The digital intervention uses behavior models to encourage and support healthier habits. Some participants at certain workplaces will also experience environmental interventions to study combined effects. During the study, participants will have assessments including body measurements, blood pressure, blood tests, and a 2-hour oral glucose tolerance test at the start and after one year. They will complete detailed digital questionnaires about lifestyle, health, and well-being. Researchers will track changes in diet, physical activity, body weight, and blood glucose over one year and at multiple follow-up points up to 20 years. Additional outcomes include waist circumference, insulin levels, blood pressure, mental well-being, quality of life, and health care use. The study includes safety monitoring and long-term observation of participants.
CONDITIONS
STOP DIABETES - Knowledge-based Solutions
J
Jussi Pihlajamäki, MD, PhD
T
Timo A Lakka, MD, PhD
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University of Eastern Finland
Lead Sponsor
National Institute of Health and Welfare
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive lifestyle interventions to improve diet quality, physical activity, body weight, and glucose tolerance. This includes using a digital self-help tool for 12 months, with some participants also attending six face-to-face group coaching sessions.
Digital usage throughout 12 months; 6 face-to-face group coaching sessions for participants in combined intervention group
Duration - Up to 20 years after baseline
Participants have follow-up examinations to assess changes in health and lifestyle up to 20 years after baseline.
Visits at 1-year, 3, 5, 10, 15, and 20 years after baseline
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/30823909/Timo A Lakka, Kirsikka Aittola, Elina Järvelä-Reijonen...
https://pubmed.ncbi.nlm.nih.gov/36620354/University of Eastern Finland
Lead Sponsor
National Institute of Health and Welfare
Collaborating Sponsor