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| Name | Class |
|---|---|
| University of Leeds | OTHER |
| Salk Institute for Biological Studies | OTHER |
| University of Copenhagen | OTHER |
| Glostrup University Hospital, Copenhagen |
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The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).
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 relapse of old habits and 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 and cardiovascular risk, including body weight and glycaemia during the intervention, but weight regain is 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' approach where both individual capabilities and motivation as well as social and contextual factors are more or less ignored. A user-based design could facilitate enrolment of participants and promote implementation 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. TRE limits the time available for food intake to typically 8-10 hours/day without other dietary restrictions and has been put forward as a novel, acceptable, and safe strategy that has shown promising effects on body weight, glucose metabolism, appetite, and cardiometabolic health in individuals at high risk of T2D.
Although it has been suggested that TRE is a safe and feasible intervention, the longer-term effectiveness of TRE on glycaemic control and weight loss in individuals with T2D is unknown alongside the long-term acceptability and sustainability. Additionally, potential social and contextual challenges associated with integration of TRE into ordinary daily life structure and routines call for new approaches to support the individual in implementing and maintaining the strategy.
Overall, the RESET2 study consists of three phases; 1) Need assessment, 2) Pilot study, and 3) RCT. The aim of the present study (RCT) is to investigate the effectiveness of implementing a 1-year TRE-based intervention in individuals with overweight/obesity and T2D. Participants will attend 6 visits at Steno Diabetes Center Copenhagen (SDCC): Visit 0 (screening), Visit 1 (baseline, minimum 10 days after screening), Visit 2 (10 days prior to visit 3), Visit 3 [3 months (12 weeks) after baseline], Visit 4 (10 days prior to visit 5), Visit 5 [12 months (52 weeks) after baseline].
The specific objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating | Experimental | TRE group for 1 year: The intervention consists of a 3-month (12 weeks) strict TRE period, where participants follow the same eating window each day with minimal support, followed by a 9-month (40 weeks) period of individually adjusted TRE according to their experiences. |
|
| Control | No Intervention | Control group for 1 year: Participants will be instructed to continue their habitual lifestyle during the study and they will follow standard care with regular visits at the SDCC clinic 3-4 times/year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating | Other | 3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions. 9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (mmol/mol) | Assessed from blood samples in fasted state. | Change from baseline to 3-months of intervention (strict TRE) |
| Change in HbA1c (mmol/mol) | Assessed from blood samples in fasted state. | Change from baseline to the end of the intervention (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Measured on a digital scale in a fasted state. | Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Fat mass (kg) | Measured by Dual-energy X-ray Absorptiometry in a fasted state. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Measured on a digital scale in a fasted state. | Change from baseline to 3 months |
| Height (m) | Height will be measured in order to calculate BMI. |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for the sub-study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas S Quist, PhD | Contact | +45 26176064 | jonas.salling.quist@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jonas S Quist, PhD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Recruiting | Herlev | Denmark | 2730 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000093763 | Intermittent Fasting |
| D009765 | Obesity |
| D050177 | Overweight |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Time in range (% 3.9-10.0 mmol/l) | Measured using continous glucose monitoring. | Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Use of antidiabetic medication | Change in current use of antidiabetic medication from baseline to end of the intervention (12 months). | Change from baseline to end of the intervention (12 months). Assessed at baseline, 3 months, 12 months. |
| Measured only at screening |
| Body mass index (kg/m^2) | Weight and height measurements will be used to calculate BMI in kg/m^2. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Fat mass (kg) | Measured by Dual-energy X-ray Absorptiometry in a fasted state. | Change from baseline to 3 months |
| Time in range (% 3.9-10.0 mmol/l) | Measured using continous glucose monitoring. | Change from baseline to 3 months |
| Use of antidiabetic medication | Change in current use of antidiabetic medication from baseline to 3 months | Change from baseline to 3 months |
| Change in overall medication use | Change in medication use (e.g. blood pressure, lipid-lowering medication etc) | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Blood lipids (mmol/l) | Fasting concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Fat free mass (kg) | Measured by Dual-energy X-ray Absorptiometry in a fasted state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Insulin (pmol/L) | Fasting concentration of insulin | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Glucagon (pmol/L) | Fasting concentration of glucagon | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-C-peptide (pmol/L) | Fasting concentration of C-peptide | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Leptin (pmol/L) | Fasting concentration of leptin | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Fibroblast growth factor 21 (pmol/L) | Fasting concentration of fibroblast growth factor 21 | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Glucagon-like peptide-1 (pmol/L) | Fasting concentration of glucagon-like peptide-1 | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Glucose-dependent insulinotropic polypeptide (pmol/L) | Fasting concentration of glucose-dependent insulinotropic polypeptide | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Ghrelin (pmol/L) | Fasting concentration of ghrelin | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Peptide YY (pmol/L) | Fasting concentration of peptide YY | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Neuropeptide Y (pmol/L) | Fasting concentration of neuropeptide Y | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hormones-Growth differentiating factor 15 (pmol/L) | Fasting concentration of growth differentiating factor 15 | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Marker of kidney function - Creatinine (µmol/L) | Fasting concentration of creatinine | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Marker of kidney function - eGFR (mL/min) | Estimated glomerular filtration rate (eGFR) | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Plasma beta-hydroxybutyrate (mmol/L) | Fasting concentration of plasma beta-hydroxybutyrate | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Marker of liver function - Aspartate-aminotransferase (U/L) | Fasting concentration of aspartate-aminotransferase | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Marker of liver function - Alanine aminotransferase (U/L) | Fasting concentration of alanine-aminotransferase | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Marker of liver function - Thrombocytes (x10^9/L) | Fasting concentration of thrombocytes (for estimating liver-fibrosis) | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Markers of inflammation- Tumor necrosis factor alpha (pmol/L) | Fasting concentration of Tumor necrosis factor alpha | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Markers of inflammation-Adiponectin (pmol/L) | Fasting concentration of adiponectin | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Markers of inflammation-C-reactive protein (mg/L) | Fasting concentration of C-reactive protein | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Markers of inflammation-Interleukin 6 (pmol/L) | Fasting concentration of interleukin 6 | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Time Below Range (% <3.9 mmol/l) | Measured using continous glucose monitoring. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Time Above Range (% >10.0 mmol/l) | Measured using continous glucose monitoring. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Coefficient of variation (CV) of glucose concentrations | Measured using continous glucose monitoring. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Mean glucose concentrations | Measured using continous glucose monitoring. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Standard deviation of glucose concentrations | Measured using continous glucose monitoring. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Systolic blood pressure (mmHg) | Measured in a fasted and rest state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Diastolic blood pressure (mmHg) | Measured in a fasted and rest state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Resting heart rate (bpm) | Measured in a fasted and rest state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Waist circumference (cm) | Measured using tape measure in a fasted state. The average of three consecutive measurements is reported. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Hip circumference (cm) | Measured using tape measure in a fasted state.The average of three consecutive measurements is reported. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Waist/hip ratio | The ratio of the circumference of the waist to that of the hips. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Degree of liver fibrosis (kPa) | Measured by FibroScan in a fasted state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Degree of liver steatosis (dB/m) | Measured by FibroScan in a fasted state. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Food choice | Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Attention | Measured using eye tracking in response to looking at food pictures during the SBFPT. Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score >0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Reaction time (ms) | Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Explicit liking | Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales (VAS) and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale). | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Explicit wanting | Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using VAS and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale). | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Implicit wanting | Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm). In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred.The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value). | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported binge eating disorder | Assessed from 2 questions (question 13,14) of Binge Eating Disorder Examination Questionnaire (EDE-Q 6.0). | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported physical activity | Assessed from the Physical Activity Scale 1 (PAS1) | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported sleep quality | Assessed from the Pittsburgh Sleep Quality Index (PSQI).The questionnaire consists of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported information on social relations and social support | Assessed from 2 items (items 68 and 70) of social relations and social support questionnaire (the Danish National Health Survey, item 68 and 70). The questions refer to contact with other people. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported sleepiness | Assessed from the Epworth Sleepiness Scale (ESS).The questionnaire consists of 8 questions, which is weighted on a 0-3 interval scale. A low total score can be interpreted as a normal daytime sleepiness, and a higher score as a mild, moderate and severe excessive daytime sleepiness, respectively. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported eating behavior | Assessed from the Dutch Eating Behavior Questionnaire (DEBQ). The questionnaire consists of 33 items and comprises three scales that measure emotional, external and restrained eating.Items can be rated from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported night eating | Assessed from the Night Eating Questionnaire (NEQ). The questionnaire consists of 14 items, that can be rated from 0 to 4. All items except item 13 are summed to obtain a global score. A total score ≥ 25 has been proposed as a lenient threshold for night eating syndrome. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported food intake | Assessed from the food intake questionnaire (23-item FFQ). The questionnaire collects dietary data and uses a context-specific food list to estimate the usual diet. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported diabetes distress | Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥ 8 indicates possible diabetes related emotional distress. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported sexual functioning/well-being | Assessed from 1 item of the questionnaire the Danish National Health Survey (item 79) and 4 items of the questionnaire Danish PRO scheme (diabetes) (item 46 and 63-65). | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-reported mood | Assessed from the Major Depression Inventory (MDI). The questionnaire consists of 10 items. Each item can be rated from 0 to 5.The total score ranges from 0 to 50. A total score <20 indicates depression does not exist or its existence is doubtful, 20-24 indicates mild depression, 25-29 indicates moderate depression, and >29 indicates severe depression. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Self-assessed questionnaire to determine morningness-eveningness in human circadian rhythm | Assessed by the Morningness-Eveningness Questionnaire (MEQ). The questionnaire consists of 19 items. Each item can be rated from 0 to 4-7. The total score ranges from 16 to 86. The lower score the more eveningness, and the higher score the more morningness. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Subjective appetite | Subjective appetite will be assessed using Visual analogue scales (VAS), including ratings of hunger, fullness, satiety and prospective food consumption, thirst, desire to eat something sweet, salty, fatty, meat, and potential nausea. | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Cognition | Cognitive functions will be assessed by Screen for Cognitive Impairment in Psychiatry Danish Version (SCIP-D) together with the Trail Making Test-Part B (psychomotor speed and executive function) and the Cognitive Failures Questionnaire | Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months |
| Dim light melatonin onset (DLMO) (subgroup only) | DLMO is a standard biomarker for measuring circadian rhythms and can easily be measured at home by saliva sampling. Saliva samples must be taken every 60 minutes under dim light (<30 lux) for at least 1 hour prior to and throughout the expected rise in melatonin. | Change from baseline to 3 months. Measured at baseline and 3 months |
| Brain insulin resistance (subgroup only) | Cerebral blood flow assessed by MRI in response to intranasal insulin administration in a subgroup of participants. A basal MRI will be conducted and afterwards 160 U insulin will be administered intranasally by spraying 2 puffs per nostril (each containing 10 U of insulin) every minute over 4 minutes followed by MRI 30 minutes after the last administration | Change from baseline to 3 months. Assessed at baseline and 3 months. |
| Adherence (%) | Degree of adherence to eating windows = (number of days where eating window was reduced by minimum 3 hours compared to habitual eating window and participants have reported an eating window below 10 hours / total number of days in intervention) * 100%. | Registered 2 days/week on random days via an online questionnaire. |
| Degree of participants' participation in intervention activities - Visits | Assessed from % participation in the 5 intervention visits | Visit 1, visit 2, visit 3, visit 4, visit 5 |
| Degree of participants' participation in intervention activities - Conversations | Assessed from % participation in the conversations at visit 1 and 3 (TRE group only) | Conversations at visit 1 and visit 3 |
| Degree of participants' participation in intervention activities - Peer support group meetings | Assessed from % participation in peer support group meetings (TRE group only) | Support group meetings will be held once monthly |
| Degree of participants' participation in intervention activities - Phone calls | Assessed from % participation in the phone calls (TRE group only) | Phone calls after 2, 6, 9 weeks + Phone calls after 6 and 9 months |
| Participants' acceptance of TRE | Assessed by interviews on participants' acceptance of TRE in terms of bodily/physical experiences, motivation, and ability to manage TRE in daily living and how intervention activities were supportive. This refers only to the TRE group. Individual interviews will be conducted by a qualitative researcher with a sub-group of participants in the TRE group (n=30) representing experiences with a variety of individual adjustments after the last visit, and focus group interviews will be performed with a sub-group of participants in the TRE group (n=30) choosing peer support or family involvement. Participants are free to say yes or no to participate in interviews.These interviews will be audio recorded. | The interviews will be conducted at the end of intervention (1 year after baseline) at visit 5 |
| Energy intake (kJ) | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| Fat energy percent | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| Carbohydrate energy percent | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| Protein energy percent | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| Alcohol energy percent | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| Dietary fibers (gram) | Assessed from 3-day dietary records | Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5) |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |