A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)
Steno Diabetes Center Copenhagen
24 participants
Sep 30, 2025
INTERVENTIONAL
Conditions
Summary
The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
After 12 weeks of following a VLCD (Phase 1), participants begin a 6-week transition (Phase 2). During this phase, they adopt a CH-rich diet, consuming 50-55% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity \>70% peak oxygen uptake (VO2peak) and/or \>7 on the Rate of Perceived Exertion scale (RPE), equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session per week.
After 12 weeks of following a VLCD (Phase1), participants begin a six-week transition (Phase 2 ). During this phase, they adopt a CH-reduced diet, consuming 25-30% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity \>70% peak oxygen uptake (VO2peak) and/or \>7 on the RPE scale, equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session peer week.
Locations(1)
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NCT07262788