Childhood ObesityTRECONCT06583447
Time Restricted Eating in Childhood Obesity (TRECO)
A study testing Calorie-restricted diet (CRD) and Time-restricted eating (TRE) in people with Childhood Obesity, run by Xiaoyan Shi at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Calorie-restricted diet (CRD) and Time-restricted eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- 28 Sep 2024to Apr 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 8-17 years.
- Childhood obesity: BMI-z score \> 2.
- Agree to participate in this study and signed an informed consent form.
Who cannot join
- Individuals who have been actively fasting for more than 12 hours/day.
- Diabetic patients on hypoglycemic medications.
- Individuals undergoing weight loss interventions or previous bariatric surgery.
- Individuals with psychiatric, intellectual developmental disorders, or aphasia.
- Individuals on appetite or weight-suppressing medications within the last three months (e.g., antipsychotics, hypnotics, weight-loss drugs, insulin).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Children's Hopital of Soochow University
Suzhou, Jiangsu, 215123
Hao Peng, PhD, +86 051265880079, penghao@suda.edu.cn
Xiaoyan Shi, PhD, +86 51280693533, xyshi@suda.edu.cn
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215123
Mengxuan Ye, MBBS, 18801542468, 624442531@qq.com
Xiaoyan Shi, PhD, +86 51280693533, xyshi@suda.edu.cn
About this study
Official title: Time Restricted Eating in Childhood Obesity: An Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. It will also learn about the safety and long-term adherence of 12-hour TRE, in comparison to calory restricted diet (CRD) . The main questions it aims to answer are:
- Is the weight-losing effect of 12-hour TRE better than CRD?
- Is 12-hour TRE easier to adhere to than CRD?
Read more
Researchers will compare 12-hour TRE to CRD (the primary treatment for obesity) to see if 12-hour TRE works to treat childhood obesity.
Participants will:
- Follow the 12-hour TRE or CRD diet every day for 48 weeks;
- Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests;
- Keep a diary of their diet, physical activity, and symptoms
Read the detailed description
Childhood obesity is a major metabolic disorder affecting approximately 20% of children and adolescents. Calory-restricted diet (CRD) is the primary treatment for obesity, but adherence to CRD typically declines over time and many individuals who lose weight with this strategy regain it. Accumulating evidence suggests that time-restricted eating (TRE), an alternative method of reducing energy intake that has gained popularity in recent years, has a significant weight-losing effect on adult obesity. However, its weight-losing effect on childhood obesity is still lacking trial evidence.
The overall objective of this study is to test the effectiveness of 12-hour TRE on weight loss for childhood obesity in comparison with CRD. The secondary objective is to compare the long-term adherence and weight-losing effect between the two dietary interventions.
The TRECO study is an open-label, blinded endpoint, parallel design, randomized controlled trial planned to enroll 128 patients with childhood obesity (8-17 years old, BMI-Z value \>2), randomized by sex and age (12 years old) into zonal groups, and on the basis of the conventional non-pharmacological interventions, TRE was given to the intervention group, and CRD was given to the control group, and the short-term effect of TRE was observed after 12 weeks of intervention The short-term effect of TRE was observed after 12 weeks of intervention, i.e., to compare the difference in the magnitude of BMI-Z reduction between the two groups. The intervention was extended to 48 weeks to observe the long-term effect of TRE by comparing the difference in the reduction of BMI-Z between the two groups.
- Conditions
- Childhood Obesity
- Being tested
- Calorie-restricted diet (CRD), Time-restricted eating (TRE)
- Keywords
- Childhood Obesity, Calory-restricted diet, time-restricted eating
- Medical subject headings
- Pediatric Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie-restricted diet (CRD)Behavioural
Standardized lifestyle interventions for all obese children and their parents will be constructed by endocrinologists and dietitians to increase physical activity and healthy eating habits. Physical activity interventions include decreasing time spent in sedentary activities, increasing the amount of physical activity, and recommending at least 60 minutes of moderate-intensity exercise per day. Individualized dietary counseling is provided to address the comorbidities in obese children.
Based on the standardized lifestyle intervention, the study subjects in the control group will be treated with CRD. Total daily energy intake will be restricted to 80% of the energy requirement for each age group in the Dietary Reference Intakes of Nutrients for Chinese Residents DRIs 2013. A daily food diary will be kept for at least one weekday and one weekend per week.
Time-restricted eating (TRE)Behavioural
Based on the standardized lifestyle intervention mentioned by the calorie-restricted diet (CRD) intervention, TRE is administered to the study subjects in the intervention group. The eating window is limited to 12 hours per day, with the last meal no later than 7:00 p.m., and the study subjects are free to choose their eating window. Energy intake is not restricted during the eating period, and calorie-free, sugar-free beverages (water, tea, coffee) are allowed during the fasting period. A daily food diary will be kept for at least one weekday and one weekend per week.
| Study group | Role | What they receive |
|---|---|---|
| CRD group | Active comparator | Based on the standardized lifestyle intervention, the study subjects in the control group will be treated with CRD. Total daily energy intake will be restricted to 80% of the energy requirement for each age group in the Dietary Reference Intakes of Nutrients for Chinese Residents DRIs 2013. A daily food diary will be kept at least one weekday and one weekend per week. Receives: Behavioral: Calorie-restricted diet (CRD) |
| TRE group | Experimental | Based on the standardized lifestyle intervention, TRE is administered to the study subjects in the intervention group. The eating window is limited to 12 hours per day, with the last meal no later than 7:00 p.m., and the study subjects are free to choose their eating window. Energy intake is not restricted during the eating period, and calorie-free, sugar-free beverages (water, tea, coffee) are allowed during the fasting period. A daily food diary will be kept for at least one weekday and one weekend per week. Receives: Behavioral: Time-restricted eating (TRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI-Z score
Weight and height are monitored at all-time points with an electronic scale and stadiometer and combined to calculate BMI-Z score based on the WHO growth charts. Participants will wear minimal clothing during the height and weight measurements.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Secondary outcomes (10)
Weight attainment rate
Weight and height are monitored at all-time points with an electronic scale and stadiometer and combined to calculate BMI-Z score based on the WHO growth charts. Participants will wear minimal clothing during the height and weight measurements. Weight attainment is defined as a BMI-Z score <2.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in body composition
Body composition is assessed by bioimpedance with a Tanita MC-780 BC instrument, available at the Hospital's Endocrinology department. We are monitoring the absolute amount and percentage of both total body fat and lean mass as well as abdominal fat mass at all time points.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Quality of life
Quality of life scale for children and adolescents (QLSCA), a multi-dimensional self-evaluation scale for learning and life, covering physical, psychological, social function and living environment, is suitable for primary and middle school students aged 7 to 18.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Sleep quality
Sleep quality was assessed by a total score of the Pittsburgh Sleep Quality Index (PSQI).
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Eating behavior
Children eating behavior questionnaire (Children's Eating Behavior Questionnaire, CEBQ) using 35 items, 8 subscale to assess children's eating behavior habits. CEBQ measures food "close" (food response, food enjoyment, emotional overeating, drink desire) and food "avoidance" (satiety reaction, eating slowly, picky, and emotional deficiency) eating behavior.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Adherence
Leveraging dietary diary, the compliance will be assessed by days when study subjects completed the dietary intervention program.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Energy intake
24 hour meal review through the whole study
Measured: Every week from enrollment to the end of treatment at 48 weeks
Change in hemoglobin A1c
Blood biochemical analyzer was used to detect hemoglobin A1c as the indicator of glucose metabolism.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in low density lipoprotein cholesterol
Blood biochemical analyzer was used to detect low density lipoprotein cholesterol to assess lipids metabolism.
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in systolic blood pressure
Sitting blood pressure was measured three times at resting state, with the mean as blood pressure. Systolic blood pressure was used to assess the blood pressure control..
Measured: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start28 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoyan Shi
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Sponsor-investigator, Xiaoyan Shi, Children's Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583447
- Sponsor's protocol ID
- TRECO-suzhou
- Other IDs
- ChiCTR2400088243
- Acronym
- TRECO
- Status last verified
- May 2026
- First submitted
- 29 Aug 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol of this study will be published in open peer-reviewed journals very soon.
Publications
Varady KA, Cienfuegos S, Ezpeleta M, Gabel K. Clinical application of intermittent fasting for weight loss: progress and future directions. Nat Rev Endocrinol. 2022 May;18(5):309-321. doi: 10.1038/s41574-022-00638-x. Epub 2022 Feb 22.
PubMed 35194176de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.
PubMed 31881139Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112.
PubMed 22087679Bjerregaard LG, Jensen BW, Angquist L, Osler M, Sorensen TIA, Baker JL. Change in Overweight from Childhood to Early Adulthood and Risk of Type 2 Diabetes. N Engl J Med. 2018 Apr 5;378(14):1302-1312. doi: 10.1056/NEJMoa1713231.
PubMed 29617589Shi X, Jiang P, Wang P, Guo X, Ye M, Jiang Z, Chen Y, Fan T, Mao G, Zhou C, Zhao L, Zhang M, Wu L, Wang J, Peng H. Study protocol for a randomized clinical trial to reduce weight among youth with obesity using time-restricted eating: the TRECO study. BMC Pediatr. 2025 Dec 3;26(1):21. doi: 10.1186/s12887-025-06298-w.
PubMed 41340042
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating in Childhood Obesity: An Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06583447
- Acronym / sponsor ID
- TRECO / TRECO-suzhou
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Calory-restricted diet, time-restricted eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xiaoyan ShiUniversity, hospital or other
- Collaborators
- Soochow University
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Sep 2024 (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.
The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. It will also learn about the safety and long-term adherence of 12-hour TRE, in comparison to calory restricted diet (CRD) . The main questions it aims to answer are:
- Is the weight-losing effect of 12-hour TRE better than CRD?
- Is 12-hour TRE easier to adhere to than CRD?
Researchers will compare 12-hour TRE to CRD (the primary treatment for obesity) to see if 12-hour TRE works to treat childhood obesity.
Participants will:
- Follow the 12-hour TRE or CRD diet every day for 48 weeks;
- Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests;
- Keep a diary of their diet, physical activity, and symptoms
Detailed description
Childhood obesity is a major metabolic disorder affecting approximately 20% of children and adolescents. Calory-restricted diet (CRD) is the primary treatment for obesity, but adherence to CRD typically declines over time and many individuals who lose weight with this strategy regain it. Accumulating evidence suggests that time-restricted eating (TRE), an alternative method of reducing energy intake that has gained popularity in recent years, has a significant weight-losing effect on adult obesity. However, its weight-losing effect on childhood obesity is still lacking trial evidence.
The overall objective of this study is to test the effectiveness of 12-hour TRE on weight loss for childhood obesity in comparison with CRD. The secondary objective is to compare the long-term adherence and weight-losing effect between the two dietary interventions.
The TRECO study is an open-label, blinded endpoint, parallel design, randomized controlled trial planned to enroll 128 patients with childhood obesity (8-17 years old, BMI-Z value \>2), randomized by sex and age (12 years old) into zonal groups, and on the basis of the conventional non-pharmacological interventions, TRE was given to the intervention group, and CRD was given to the control group, and the short-term effect of TRE was observed after 12 weeks of intervention The short-term effect of TRE was observed after 12 weeks of intervention, i.e., to compare the difference in the magnitude of BMI-Z reduction between the two groups. The intervention was extended to 48 weeks to observe the long-term effect of TRE by comparing the difference in the reduction of BMI-Z between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRD group | Active comparator | Behavioral: Calorie-restricted diet (CRD)Based on the standardized lifestyle intervention, the study subjects in the control group will be treated with CRD. Total daily energy intake will be restricted to 80% of the energy requirement for each age group in the Dietary Reference Intakes of Nutrients for Chinese Residents DRIs 2013. A daily food diary will be kept at least one weekday and one weekend per week. |
| TRE group | Experimental | Behavioral: Time-restricted eating (TRE)Based on the standardized lifestyle intervention, TRE is administered to the study subjects in the intervention group. The eating window is limited to 12 hours per day, with the last meal no later than 7:00 p.m., and the study subjects are free to choose their eating window. Energy intake is not restricted during the eating period, and calorie-free, sugar-free beverages (water, tea, coffee) are allowed during the fasting period. A daily food diary will be kept for at least one weekday and one weekend per week. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 8-17 years.
- Childhood obesity: BMI-z score \> 2.
- Agree to participate in this study and signed an informed consent form.
Key exclusion criteria (5 listed)
- Individuals who have been actively fasting for more than 12 hours/day.
- Diabetic patients on hypoglycemic medications.
- Individuals undergoing weight loss interventions or previous bariatric surgery.
- Individuals with psychiatric, intellectual developmental disorders, or aphasia.
- Individuals on appetite or weight-suppressing medications within the last three months (e.g., antipsychotics, hypnotics, weight-loss drugs, insulin).
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 |
|---|---|---|
| Calorie-restricted diet (CRD)Standardized lifestyle interventions for all obese children and their parents will be constructed by endocrinologists and dietitians to increase physical activity and healthy eating habits. Physical activity interventions include decreasing time spent in sedentary activities, increasing the amount of physical activity, and recommending at least 60 minutes of moderate-intensity exercise per day. Individualized dietary counseling is provided to address the comorbidities in obese children. Based on the standardized lifestyle intervention, the study subjects in the control group will be treated with CRD. Total daily energy intake will be restricted to 80% of the energy requirement for each age group in the Dietary Reference Intakes of Nutrients for Chinese Residents DRIs 2013. A daily food diary will be kept for at least one weekday and one weekend per week. | Behavioural | CRD group |
| Time-restricted eating (TRE)Based on the standardized lifestyle intervention mentioned by the calorie-restricted diet (CRD) intervention, TRE is administered to the study subjects in the intervention group. The eating window is limited to 12 hours per day, with the last meal no later than 7:00 p.m., and the study subjects are free to choose their eating window. Energy intake is not restricted during the eating period, and calorie-free, sugar-free beverages (water, tea, coffee) are allowed during the fasting period. A daily food diary will be kept for at least one weekday and one weekend per week. | Behavioural | TRE group |
Primary outcome
Change in BMI-Z score
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Weight and height are monitored at all-time points with an electronic scale and stadiometer and combined to calculate BMI-Z score based on the WHO growth charts. Participants will wear minimal clothing during the height and weight measurements.
10 secondary outcomes
Weight attainment rate
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in body composition
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Quality of life
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Sleep quality
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Eating behavior
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Adherence
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Energy intake
Time frame: Every week from enrollment to the end of treatment at 48 weeks
Change in hemoglobin A1c
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in low density lipoprotein cholesterol
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in systolic blood pressure
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
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 8 May 2026.
- Results publication: PubMed 35194176Varady KA, Cienfuegos S, Ezpeleta M, Gabel K. Clinical application of intermittent fasting for weight loss: progress and future directions. Nat Rev Endocrinol. 2022 May;18(5):309-321. doi: 10.1038/s41574-022-00638-x. Epub 2022 Feb 22.
- Results publication: PubMed 31881139de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.
- Results publication: PubMed 22087679Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112.
- Results publication: PubMed 29617589Bjerregaard LG, Jensen BW, Angquist L, Osler M, Sorensen TIA, Baker JL. Change in Overweight from Childhood to Early Adulthood and Risk of Type 2 Diabetes. N Engl J Med. 2018 Apr 5;378(14):1302-1312. doi: 10.1056/NEJMoa1713231.
- Derived from this study: PubMed 41340042Shi X, Jiang P, Wang P, Guo X, Ye M, Jiang Z, Chen Y, Fan T, Mao G, Zhou C, Zhao L, Zhang M, Wu L, Wang J, Peng H. Study protocol for a randomized clinical trial to reduce weight among youth with obesity using time-restricted eating: the TRECO study. BMC Pediatr. 2025 Dec 3;26(1):21. doi: 10.1186/s12887-025-06298-w.
- Individual participant dataSharing planned: No. The protocol of this study will be published in open peer-reviewed journals very soon.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie-restricted diet (CRD) and Time-restricted eating (TRE) in people with Childhood Obesity, run by Xiaoyan Shi at 2 sites in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Hao Peng, PhD (+86 051265880079, penghao@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI-Z score (time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06583447, which also lists 5 linked publications.
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 8 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.