Feasibility of Time-Restricted Eating in the Treatment of Type 2 Diabetes - the RESET2 Pilot Study

Brief Summary

Detailed Description

In people with type 2 diabetes (T2D), weight loss is associated with improved glycaemic control and markers of cardiometabolic function as well as reduced use of antidiabetic medicine. Beyond pharmacological treatments, current strategies to reduce body weight and improve glycaemia include energy-restricted diets and increased physical activity. Lifestyle interventions are complex, affecting many aspects of peoples' daily life. Dietary restrictions often result in rapid weight loss, but the weight is gradually regained by many. Barriers to implement and maintain dietary changes include lack of knowledge, support, and insights into the type and amount of foods eaten. Previous lifestyle interventions targeting weight loss in T2D show efficacy for improving markers of metabolic risk, including weight and glycaemia during the intervention, but relapse of behavior and weight regain are often present. One reason may be that the intervention is not modified according to the needs of the target group. Often, weight loss interventions are shaped by a 'one size fits all' model where both individual capabilities and motivation as well as social and contextual factors are more or less ignored. A user-based design will facilitate enrolment of participants and likely promote uptake and maintenance of the intervention among participants. Intermittent fasting regimens have been suggested as efficient strategies for improving cardiometabolic health to a greater extent than can be attributed to the reduction in energy intake alone. Time-restricted eating limits the time available for food intake to typically 4-10 hours/day without other dietary restrictions and has been put forward as a novel, acceptable, and safe lifestyle modification and has shown promising effects on body weight, glucose metabolism, appetite, and cardiometabolic health in individuals at high risk of T2D. The overall aim of this pilot study is to examine feasibility of a 12-week 10-hour time-restricted eating based intervention in individuals with overweight or obesity and T2D. Participants will attend visit 1 (baseline), visit 2 (8 weeks after baseline) and visit 3 (12 weeks after baseline). The study consists of 8 weeks of strict time-restricted eating, followed by 4 weeks of individually adjusted time-restricted eating. Specific aims are: 1. To assess adherence and participants' experiences, needs and barriers with an 8-week strict time-restricted eating period, followed by a 4-week period with an individually adjusted time-restricted eating based intervention 2. To examine whether intervention components are delivered by health care professionals as intended 3. To explore if intervention support components are acceptable, useful and sufficient for the participants 4. To study recruitment processes and retention, and related barriers and facilitators 5. To evaluate examination days

Primary Outcomes

Secondary Outcomes

• Recruitment process and retention(Up to 12 weeks.)
• Evaluation of examination days(Interviews at baseline and after 8 and 12 weeks.)
• Fidelity(Conversations at baseline and after 8 weeks.)
• Body weight (kg)(Measured at baseline and after 8 and 12 weeks)
• Body mass index (kg/m^2)(Measured at baseline and after 8 and 12 weeks.)
• Fat mass (kg)(Measured at baseline and after 12 weeks.)
• Fat free mass (kg)(Measured at baseline and after 12 weeks.)
• Fat percentage (%)(Measured at baseline and after 12 weeks.)
• Waist circumference (cm)(Measured at baseline and after 12 weeks.)
• Hip circumference (cm)(Measured at baseline and after 12 weeks.)
• HbA1c (mmol/mol and %)(Measured at baseline and after 12 weeks.)
• Systolic blood pressure (mmHg)(Measured at baseline and after 12 weeks.)
• Diastolic blood pressure (mmHg)(Measured at baseline and after 12 weeks.)
• Heart rate (bpm)(Measured at baseline and after 12 weeks.)
• Metabolites(Measured at baseline and after 12 weeks.)
• Hormone(Measured at baseline and after 12 weeks.)
• Marker of kidney function - Sodium(Measured at baseline and after 12 weeks.)
• Marker of kidney function - Potassium(Measured at baseline and after 12 weeks.)
• Marker of kidney function - Creatinine(Measured at baseline and after 12 weeks.)
• Markers of kidney function - eGFR(Measured at baseline and after 12 weeks.)
• Subjective appetite(Measured at baseline and after 12 weeks.)
• Food choice(Measured at baseline and after 12 weeks.)
• Implicit wanting(Measured at baseline and after 12 weeks.)
• Explicit liking(Measured at baseline and after 12 weeks.)
• Explicit wanting(Measured at baseline and after 12 weeks.)
• Self-reported physical activity(Measured at baseline and after 12 weeks.)
• Self-reported sleep quality(Measured at baseline and after 12 weeks)
• Self-reported health and wellbeing(Measured at baseline and after 12 weeks.)
• Self-reported sleepiness(Measured at baseline and after 12 weeks.)
• Self-reported chronotype(Measured at baseline and after 12 weeks.)
• Self-reported food intake(Measured at baseline and after 12 weeks)
• Self-reported night eating(Measured at baseline and after 12 weeks.)
• Self-reported eating behavior(Measured at baseline and after 12 weeks.)
• Self-reported control over eating(Measured at baseline and after 12 weeks.)
• Self-reported fatigue/tiredness(Measured at baseline and after 12 weeks.)
• Self-reported information on social relations and support(Measured at baseline and after 12 weeks.)
• Self-reported diabetes distress(Measured at baseline and after 12 weeks.)
• Self-reported well-being(Measured at baseline and after 12 weeks)
• Self-reported diabetes management(Measured at baseline and after 12 weeks.)
• Sexual satisfaction(Measured at baseline and after 12 weeks.)
• Sexual functioning(Measured at baseline and after 12 weeks.)