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

Self-reported adherence to a 10-hour eating window/day during a 8-week strict time-restricted eating period. % compliance = (number of days compliant/total days) * 100%.

Self-reported adherence to a 10-hour eating window during a 4-week individually adjusted time-restricted eating period. % compliance = (number of days compliant/total days) * 100%.

Analysis of conversations at visit 2 to assess participants' experiences, needs and barriers with a 8-week strict time-restricted eating period.

Analysis of interviews at visit 3 to assess participants' experiences, needs and barriers with a 4-week individually adjusted time-restricted eating period, including to explore if intervention support components are acceptable, useful and sufficient for the participants.

Registered numbers of: people with interest in the project, people attending pre-screening and screening, included participants, drop-outs and completers.

Analysis of interviews to evaluate examination days.

Assessment of the extent (%) to which the conversations are conducted according to the conversation guidelines. Average score for conversations at baseline and average score for conversations at visit 2 will be calculated.

Measured on a digital scale. Fasted state at baseline and after 12 weeks, non-fasted state after 8 weeks

Calculated from body weight (kg) and height (m). Fasted state at baseline and after 12 weeks, non-fasted state after 8 weeks.

Measured by electronical bioimpedance. Fasted state at both visits.

Measured by electronical bioimpedance. Fasted state at both visits.

Measured by electronical bioimpedance. Fasted state at both visits.

Measured using tape measure.

Measured using tape measure.

Assessed from blood samples in fasted state.

Measured under resting and fasting conditions.

Measured under resting and fasting conditions.

Measured under resting and fasting conditions during measurements of blood pressure.

Fasting concentrations of glucose, cholesterols, triglycerides.

Fasting concentration of insulin.

Fasting concentration of sodium.

Fasting concentration of potassium.

Fasting concentration of creatinine.

Estimated glomerular filtration rate (eGFR).

Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".

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 computerized Leeds Food Preference Questionnaire. 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.

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 computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time.

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 computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales 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).

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 computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales 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).

Assessed from questionnaire International Physical Activity Questionnaire, and measures health-related physical activity. To calculate MET minutes a week multiply the MET value given by the minutes the activity was carried out and again by the number of days that that activity was undertaken.

Assessed from the questionnaire Pittsburgh Sleep Quality Index. 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.

Assessed from the questionnaire Self-reported Health (SF-12 health survey). SF-12 consists of 12 items. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the Physical Component Summary has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the Mental Component Summary may be indicative of 'clinical depression'.

Assessed from the questionnaire the Epworth Sleepiness Scale. 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.

Assessed from the questionnaire Munich Chronotype Questionnaire (MCTQ). The questionnaire consists of 17 questions to identify type of chronotype. The MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days) to assess chronotype.

Assessed from questionnaire Food Frequency Questionnaire. The questionnaire collects dietary data and uses a context-specific food list to estimate the usual diet. The questionnaire consists of 15 items with sub questions. Output is total energy intake and macronutrient composition.

Assessed from questionnaire The Night Eating Questionnaire. 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.

Assessed from questionnaire The Dutch Eating Behavior Questionnaire. It 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.

Assessed from the questionnaire Control over Eating Questionnaire. It comprises 21 items designed to assess the intensity and type of food cravings an individual experiences, as well as subjective sensations of appetite and mood. Each item can be rated from 1 to 5 on a continuous scale. a lower scale. A higher score indicate less control over eating.

Assessed from questionnaire Fatigue Assessment Scale (FAS). The questionnaire consists of 10 items. Each item can be rated from 1 to 5. The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.

Assessed from 8 selected items on social relations and support from The Danish National Health Survey. Item 1-7 provides information on how often a person is in contact with other people (family, husband/wife, partners, friends, neighbors, etc.), and can be rated from 'daily or almost daily', 'once or twice weekly', 'once or twice monthly', 'less than once monthly' to 'never'. Item 8 provides information on whether a person has somebody to talk to if he/she has problems or needs support, and can be rated 'yes, always', 'yes, mostly', 'yes, sometimes', and 'no, never or almost never'.

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.

Assessed from the WHO (Five) Well-being Index. The WHO-5 consists of five statements, which respondents rate from 0 to five (in relation to the past two weeks).The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

Assessed from 9 selected items on diabetes management from the The Danish National Patient Reported Outcome Questionnaire, version 1.05. The items can be rated from 'very sure/confident' to 'not sure/confident at all'.

Assessed from 1 item on sexual satisfaction from the questionnaire The Danish National Health Survey. The item addresses to which degree a persons sexual needs are covered. The item can be rated from 'to a very high degree' to 'not at all'.

Assessed from 4 items on sexual functioning from the Danish National Patient Reported Outcome Questionnaire, version 1.05. Item 1 can be rated 'yes' or 'no'. 'Yes' represents problems with sexual functioning. Item 2-4 can be rated from 'not at all' to 'extreme', where extreme represents problems with sexual functioning.