Chronic InsomniaNCT07770516
Cognitive Behavioral Therapy for Insomnia as an Adjunct to Time-restricted Eating on Weight Loss in Adults With Overweight or Obesity and Chronic Insomnia
A study testing Flexible Time-restricted eating group (FTRE) and Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE) in people with Chronic Insomnia and Overweight/Obesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obesity (being overweight due to excess body fat) is a common health condition that increases the risk of developing problems such as diabetes, high blood pressure, and heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia, Overweight/Obesity
- What is being tested?
- Flexible Time-restricted eating group (FTRE) and Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnic Chinese;
- Age 18 years or older;
- Fulfill the criteria of chronic insomnia defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) , which are:
- manifestation of predominant, subpar sleep quantity or quality; ii. exhibition of any sleep difficulties ranging from sleep initiation, sleep maintenance to early awakening with the inability to restore sleep.
- concomitant presentation of significant distress or impairment, including fatigue or low energy, cognitive impairment, mood disturbance, behavioral problems, impaired occupational or academic functioning, impaired interpersonal or social functioning and negative impact on caregiver or family functioning; iv. sleep difficulty occurs at least three nights per week; v. sleep difficulty has been persistent for at least three months; and vi. sleep difficulty is not affected regardless of adequate opportunity given for sleep.
- With Overweight or obesity: BMI ≥ 23 kg/m2
- Weight stable for the past 3 months
- Habitual eating window ≥ 10 hours
Who cannot join
- Known cardiovascular disease;
- Type 1 or 2 diabetes mellitus;
- Current use of GLP-1 receptor agonists or other prescription weight-loss medications within the past 3 months;
- Currently on a special or prescribed diet for other reasons;
- Currently receiving any psychological treatment for insomnia;
- Previously received CBTI;
Show all 9Show fewer
- Night shift workers;
- Breastfeeding, pregnant or trying to become pregnant;
- Smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Kwok Sports Building, The Chinese University of Hong Kong
Hong Kong, 00000
Angus Pak-hung YU, PhD, (852) 39435253
About this study
Official title: Effects of Cognitive Behavioral Therapy for Insomnia (CBTI) as an Adjunct Intervention for Time-restricted Eating on Weight Loss in Adults With Overweight or Obesity and Chronic Insomnia
Obesity (being overweight due to excess body fat) is a common health condition that increases the risk of developing problems such as diabetes, high blood pressure, and heart disease. Time-restricted eating (TRE), which involves eating all meals within a set period each day, has become a popular and simple approach for weight management. However, not everyone achieves the same results from TRE. Research suggests that poor sleep and chronic insomnia can increase hunger, affect food choices, and lead to higher calorie intake, which may make weight loss more difficult.
This study aims to examine whether improving sleep can enhance the effectiveness of flexible time-restricted eating (FTRE) for weight loss. Participants will receive either FTRE alone or FTRE combined with Cognitive Behavioural Therapy for Insomnia (CBTI), a well-established treatment for chronic insomnia. By comparing these two approaches, this study will help determine whether addressing sleep problems can improve weight management outcomes in individuals with overweight or obesity and chronic insomnia. The findings may contribute to the development of more effective and comprehensive lifestyle programmes for improving both sleep and weight-related health.
Read the detailed description
This study aims to investigate whether CBTI can enhance the effectiveness of TRE for weight control in adults with chronic insomnia and overweight or obesity. This assessor-blinded, two-arm, parallel-group randomized controlled pilot trial plans to recruit 50 Chinese adults aged 18 years or older with chronic insomnia and overweight or obesity (BMI ≥23 kg/m²) in Hong Kong. Participants will be randomized (1:1) to a flexible time-restricted eating group (FTRE, n=25) or a flexible time-restricted eating plus CBTI group (CBTI+FTRE, n=25). Both groups will follow a 16:8 time-restricted eating schedule for 12 weeks, while participants in the CBTI+FTRE group will additionally receive a 12-week group-based CBTI program consisting of biweekly 90-minute sessions. Assessments will be conducted at baseline, post-intervention (week 12), and follow-up (week 24). The primary outcome is body weight. Secondary outcomes include body mass index, waist and neck circumferences, body composition, insomnia severity, sleep quality, objective and subjective sleep parameters, physical activity, blood pressure, appetite, food intake, eating window, and exercise habits. We hypothesize that the addition of CBTI to TRE will result in greater weight loss and improved sleep outcomes compared with TRE alone
- Conditions
- Chronic Insomnia, Overweight/Obesity
- Being tested
- Flexible Time-restricted eating group (FTRE), Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE)
- Keywords
- Chronic insomnia, Time-restricted eating, Cognitive Behavioural Therapy of Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Time-restricted eating group (FTRE)Behavioural
Participants assigned to the FTRE group will be instructed to follow a 16:8 time-restricted eating schedule, consuming food ad libitum within an 8-hour eating window and fasting for the remaining 16 hours of the day. No restrictions will be placed on the type or quantity of foods consumed during the eating window, and participants will not be required to track their energy intake. During fasting periods, participants will be encouraged to maintain adequate hydration by drinking water and may also consume non-caloric beverages, such as plain tea or black coffee. Participants will be allowed to select their preferred 8-hour eating window, provided it begins between 8:00 AM and 12:00 PM and ends between 4:00 PM and 8:00 PM.
Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE)Behavioural
In addition to following the TRE instruction in the TRE group, participants in the CBTI+TRE group will also participate in a 12-week group-based CBTI intervention with biweekly 90-minute sessions. The intervention comprises all CBTI elements, including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and stress and relaxation techniques. Intervention will be delivered by trained research personnel.
| Study group | Role | What they receive |
|---|---|---|
| FTRE | Active comparator | Flexible Time-restricted Eating Receives: Behavioral: Flexible Time-restricted eating group (FTRE) |
| CBTI+FTRE | Experimental | Flexible Time-restricted Eating plus Cognitive Behavioural Therapy for Insomnia Receives: Behavioral: Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Body weight will be measured using a bioelectrical impedance analyzer (BIA) to the nearest 0.1 kg following a minimum 4-hour fast. Participants will be instructed to void their bladder immediately before the assessment, remove their shoes and heavy clothing, and stand upright on the analyzer platform during the measurement.
Measured: 12 weeks, and 24 weeks
Secondary outcomes (31)
Body mass index (BMI)
BMI will be calculated as weight in kilograms divided by the square of height in meters.
Measured: 12 weeks, and 24 weeks
Waist circumference
Waist circumference will be measured using the protocol of World Health Organisation (i.e. the circumference at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest). Waist circumference will be measured to the nearest 0.1cm.
Measured: 12 weeks, and 24 weeks
Fat percentage
Fat percentage will be measured using a bioelectrical impedance analyzer (BIA).
Measured: 12 weeks, and 24 weeks
Fat mass
Fat mass will be calculated as weight multiplied by fat percentage.
Measured: 12 weeks, and 24 weeks
Fat free mass
Fat free mass will be calculated as weight subtracted by fat mass.
Measured: 12 weeks, and 24 weeks
Insomnia Severity Index (ISI)
The ISI, a commonly used instrument in clinical settings, will be used to assess the perceived insomnia severity. It consists of seven items to evaluate sleep onset, sleep maintenance, early awakening, satisfaction with the current sleep pattern, impairment of daily functioning due to sleep, noticeable impairment due to sleep problems, degree of distress and concerns caused by sleep problems. Each item is rated on a "0-4" Likert scale, resulting in a range of scores between 0 and 28. The higher the score, the higher the perceived severity.
Measured: 12 weeks, and 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Subjective sleep quality will be evaluated using the PSQI. The PSQI assesses 7 components of subjective sleep quality, including self-reported sleep quantity, use of sleep medication, and disturbances of sleep, and is considered one of the most frequently used assessments of subjective sleep quality. The total score of the PSQI ranges from 0 to 21, where lower values indicate better sleep.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated sleep onset latency
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. sleep onset latency) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated total sleep time
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. total sleep time) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated wake time after sleep onset
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. wake time after sleep onset) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated sleep efficiency
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. sleep efficiency) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated number of awakenings
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. number of awakenings) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Actigraphy-estimated average awaken time
Participants will be instructed to wear a wrist actigraph device (wGT3X-BT, ActiGraph) on their non-dominant wrists 24 hours for 7 days to measure objective sleep. This device is a 3-axis accelerometer that estimates wakefulness and sleep based on detected movements. The 7-day average of objective sleep parameters (i.e. average awaken time) will be estimated by the data in the actigraphy record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated sleep onset latency
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. sleep onset latency) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated total sleep time
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. total sleep time) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated wake time after sleep onset
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. wake time after sleep onset) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated sleep efficiency
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. sleep efficiency) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated number of awakenings
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. number of awakenings) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Sleep diary-estimated average awaken time
Participants will be instructed to record their sleep pattern, including on-bed time, leave bed time, total sleep time and the number of awakenings, for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. average awaken time) will be estimated by the sleep diary record.
Measured: 12 weeks, and 24 weeks
Habitual physical activity (Total volume of physical activity, MET-minutes/week)
The Chinese version of the International Physical Activity Questionnaire, Long Form (IPAQ-LC), will be used to assess the activity levels of the participants.
Measured: 12 weeks, and 24 weeks
Habitual physical activity (Total sedentary time, hours/week)
The Chinese version of the International Physical Activity Questionnaire, Long Form (IPAQ-LC), will be used to assess the activity levels of the participants.
Measured: 12 weeks, and 24 weeks
Systolic blood pressure
Blood pressure will be measured in accordance with the American Heart Association's scientific statement on blood pressure assessment in humans. Participants will be instructed to sit quietly with their back supported, feet flat on the floor, and legs uncrossed. After resting in this position for 5 minutes, measurements will be taken using an electronic blood pressure monitor. During the procedure, the participant's right upper arm will be supported at heart level on a flat surface, and they will be asked to refrain from talking throughout both the resting period and the measurement. Two readings of systolic blood pressure will be obtained, spaced 2 minutes apart, and the average of the two measurements will be recorded as the final blood pressure reading. If the difference between the two measurements exceeds 5 mmHg, an additional reading will be taken, and the average of all three readings will be used as the final measurement.
Measured: 12 weeks, and 24 weeks
Diastolic blood pressure
Blood pressure will be measured in accordance with the American Heart Association's scientific statement on blood pressure assessment in humans. Participants will be instructed to sit quietly with their back supported, feet flat on the floor, and legs uncrossed. After resting in this position for 5 minutes, measurements will be taken using an electronic blood pressure monitor. During the procedure, the participant's right upper arm will be supported at heart level on a flat surface, and they will be asked to refrain from talking throughout both the resting period and the measurement. Two readings of diastolic blood pressure will be obtained, spaced 2 minutes apart, and the average of the two measurements will be recorded as the final blood pressure reading. If the difference between the two measurements exceeds 5 mmHg, an additional reading will be taken, and the average of all three readings will be used as the final measurement.
Measured: 12 weeks, and 24 weeks
Appetite (Hunger)
Subjective hunger will be assessed using validated 100-mm Visual Analogue Scales (VAS) administered upon waking, before and 30 minutes after the first and last meals, and before bedtime. Higher scores will indicate greater perceived hunger.
Measured: 12 weeks, and 24 weeks
Appetite (Satiety)
Subjective satiety will be assessed using validated 100-mm Visual Analogue Scales (VAS) administered upon waking, before and 30 minutes after the first and last meals, and before bedtime. Higher scores will indicate greater perceived fullness.
Measured: 12 weeks, and 24 weeks
Food intake (Total energy intake)
Participants will be instructed to complete a consecutive 3-day food diary, including 2 weekdays and 1 weekend day. Total energy intake will be estimated based on the dietary records.
Measured: 12 weeks, and 24 weeks
Food intake (Carbohydrate consumption)
Participants will be instructed to complete a consecutive 3-day food diary, including 2 weekdays and 1 weekend day. Carbohydrate consumption will be estimated based on the dietary records.
Measured: 12 weeks, and 24 weeks
Food intake (Protein consumption)
Participants will be instructed to complete a consecutive 3-day food diary, including 2 weekdays and 1 weekend day. Protein consumption will be estimated based on the dietary records.
Measured: 12 weeks, and 24 weeks
Food intake (Fat consumption)
Participants will be instructed to complete a consecutive 3-day food diary, including 2 weekdays and 1 weekend day. Fat consumption will be estimated based on the dietary records.
Measured: 12 weeks, and 24 weeks
Eating window
Participants will be required to record the start time of their first caloric intake and the end time of their last caloric intake in the seven-day log. The eating window will be calculated as the time interval between the first and last eating occasions of the day.
Measured: 12 weeks, and 24 weeks
Exercise habit
Participants will be instructed to complete a 7-day exercise log. The log will capture information on all exercise activities undertaken during the weeks, including the date, start and end times, exercise type, and exercise intensity.
Measured: 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angus Pak-Hung Yu, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770516
- Sponsor's protocol ID
- TRE_CBTI_1
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavioral Therapy for Insomnia (CBTI) as an Adjunct Intervention for Time-restricted Eating on Weight Loss in Adults With Overweight or Obesity and Chronic Insomnia
- ClinicalTrials.gov ID
- NCT07770516
- Acronym / sponsor ID
- TRE_CBTI_1
- Conditions
- Chronic Insomnia, Overweight/Obesity
- Keywords
- Chronic insomnia, Time-restricted eating, Cognitive Behavioural Therapy of Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity (being overweight due to excess body fat) is a common health condition that increases the risk of developing problems such as diabetes, high blood pressure, and heart disease. Time-restricted eating (TRE), which involves eating all meals within a set period each day, has become a popular and simple approach for weight management. However, not everyone achieves the same results from TRE. Research suggests that poor sleep and chronic insomnia can increase hunger, affect food choices, and lead to higher calorie intake, which may make weight loss more difficult.
This study aims to examine whether improving sleep can enhance the effectiveness of flexible time-restricted eating (FTRE) for weight loss. Participants will receive either FTRE alone or FTRE combined with Cognitive Behavioural Therapy for Insomnia (CBTI), a well-established treatment for chronic insomnia. By comparing these two approaches, this study will help determine whether addressing sleep problems can improve weight management outcomes in individuals with overweight or obesity and chronic insomnia. The findings may contribute to the development of more effective and comprehensive lifestyle programmes for improving both sleep and weight-related health.
Detailed description
This study aims to investigate whether CBTI can enhance the effectiveness of TRE for weight control in adults with chronic insomnia and overweight or obesity. This assessor-blinded, two-arm, parallel-group randomized controlled pilot trial plans to recruit 50 Chinese adults aged 18 years or older with chronic insomnia and overweight or obesity (BMI ≥23 kg/m²) in Hong Kong. Participants will be randomized (1:1) to a flexible time-restricted eating group (FTRE, n=25) or a flexible time-restricted eating plus CBTI group (CBTI+FTRE, n=25). Both groups will follow a 16:8 time-restricted eating schedule for 12 weeks, while participants in the CBTI+FTRE group will additionally receive a 12-week group-based CBTI program consisting of biweekly 90-minute sessions. Assessments will be conducted at baseline, post-intervention (week 12), and follow-up (week 24). The primary outcome is body weight. Secondary outcomes include body mass index, waist and neck circumferences, body composition, insomnia severity, sleep quality, objective and subjective sleep parameters, physical activity, blood pressure, appetite, food intake, eating window, and exercise habits. We hypothesize that the addition of CBTI to TRE will result in greater weight loss and improved sleep outcomes compared with TRE alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTRE | Active comparator | Behavioral: Flexible Time-restricted eating group (FTRE)Flexible Time-restricted Eating |
| CBTI+FTRE | Experimental | Behavioral: Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE)Flexible Time-restricted Eating plus Cognitive Behavioural Therapy for Insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ethnic Chinese;
- Age 18 years or older;
- Fulfill the criteria of chronic insomnia defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) , which are:
- With Overweight or obesity: BMI ≥ 23 kg/m2
- Weight stable for the past 3 months
Key exclusion criteria (9 listed)
- Known cardiovascular disease;
- Type 1 or 2 diabetes mellitus;
- Current use of GLP-1 receptor agonists or other prescription weight-loss medications within the past 3 months;
- Currently on a special or prescribed diet for other reasons;
- Currently receiving any psychological treatment for insomnia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Time-restricted eating group (FTRE)Participants assigned to the FTRE group will be instructed to follow a 16:8 time-restricted eating schedule, consuming food ad libitum within an 8-hour eating window and fasting for the remaining 16 hours of the day. No restrictions will be placed on the type or quantity of foods consumed during the eating window, and participants will not be required to track their energy intake. During fasting periods, participants will be encouraged to maintain adequate hydration by drinking water and may also consume non-caloric beverages, such as plain tea or black coffee. Participants will be allowed to select their preferred 8-hour eating window, provided it begins between 8:00 AM and 12:00 PM and ends between 4:00 PM and 8:00 PM. | Behavioural | FTRE |
| Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE)In addition to following the TRE instruction in the TRE group, participants in the CBTI+TRE group will also participate in a 12-week group-based CBTI intervention with biweekly 90-minute sessions. The intervention comprises all CBTI elements, including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and stress and relaxation techniques. Intervention will be delivered by trained research personnel. | Behavioural | CBTI+FTRE |
Primary outcome
Weight
Time frame: 12 weeks, and 24 weeks
Body weight will be measured using a bioelectrical impedance analyzer (BIA) to the nearest 0.1 kg following a minimum 4-hour fast. Participants will be instructed to void their bladder immediately before the assessment, remove their shoes and heavy clothing, and stand upright on the analyzer platform during the measurement.
31 secondary outcomes
Body mass index (BMI)
Time frame: 12 weeks, and 24 weeks
Waist circumference
Time frame: 12 weeks, and 24 weeks
Fat percentage
Time frame: 12 weeks, and 24 weeks
Fat mass
Time frame: 12 weeks, and 24 weeks
Fat free mass
Time frame: 12 weeks, and 24 weeks
Insomnia Severity Index (ISI)
Time frame: 12 weeks, and 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated sleep onset latency
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated total sleep time
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated wake time after sleep onset
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated sleep efficiency
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated number of awakenings
Time frame: 12 weeks, and 24 weeks
Actigraphy-estimated average awaken time
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated sleep onset latency
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated total sleep time
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated wake time after sleep onset
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated sleep efficiency
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated number of awakenings
Time frame: 12 weeks, and 24 weeks
Sleep diary-estimated average awaken time
Time frame: 12 weeks, and 24 weeks
Habitual physical activity (Total volume of physical activity, MET-minutes/week)
Time frame: 12 weeks, and 24 weeks
Habitual physical activity (Total sedentary time, hours/week)
Time frame: 12 weeks, and 24 weeks
Systolic blood pressure
Time frame: 12 weeks, and 24 weeks
Diastolic blood pressure
Time frame: 12 weeks, and 24 weeks
Appetite (Hunger)
Time frame: 12 weeks, and 24 weeks
Appetite (Satiety)
Time frame: 12 weeks, and 24 weeks
Food intake (Total energy intake)
Time frame: 12 weeks, and 24 weeks
Food intake (Carbohydrate consumption)
Time frame: 12 weeks, and 24 weeks
Food intake (Protein consumption)
Time frame: 12 weeks, and 24 weeks
Food intake (Fat consumption)
Time frame: 12 weeks, and 24 weeks
Eating window
Time frame: 12 weeks, and 24 weeks
Exercise habit
Time frame: 12 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Time-restricted eating group (FTRE) and Flexible Time-restricted eating plus cognitive behavioural therapy for insomnia group (CBTI+FTRE) in people with Chronic Insomnia and Overweight/Obesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angus Pak-hung YU, PhD ((852) 39435253, phayu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.