Overweight , ObesityRCSOGRABCICSNCT07818005
Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students
An observational study of Overweight , Obesity and Weight Loss, run by He Eye Hospital at 1 site in China.
Trial summary
This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Overweight , Obesity, Weight Loss
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2026to 15 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Overweight and obese university students (aged 18-25 years) at He University, Shenyang, Liaoning, China, whose records are contained in the archived dataset of a randomized controlled trial of a 4-week continuous glucose monitoring (CGM)-guided personalized dietary intervention. Participants had a body mass index (BMI) ≥ 24 kg/m² or elevated body fat percentage (≥ 25% in men, ≥ 32% in women) and self-reported at least two unhealthy eating behaviors. Of the 60 participants enrolled in the parent trial (30 per group), 59 were included in this retrospective analysis (30 exposed, 29 non-exposed); one non-exposed participant was excluded for missing primary outcome data. All participants were free of diabetes, prediabetes, and other exclusion conditions defined in the study protocol.
Who may be able to join
- University students aged 18 to 25 years
- Body mass index (BMI) ≥ 24.0 kg/m², or body fat percentage ≥ 25% (male) / ≥ 32% (female)
- Self-reported presence of at least two unhealthy eating behaviors
- Written informed consent
- Exclusion Criteria:• Obesity due to endocrine diseases (e.g., Cushing's syndrome, hypothyroidism, hypothalamic obesity) or genetic syndromes
- Polycystic ovary syndrome (PCOS)
Show all 16Show fewer
- Weight gain or glycemic abnormality induced by medications (e.g., glucocorticoids, antipsychotics, insulin secretagogues)
- Diagnosed diabetes (type 1 or type 2) or prediabetes (fasting glucose ≥ 6.1 mmol/L or glycated hemoglobin (HbA1c)≥ 5.7%)
- Diagnosed dyslipidemia with lipid-lowering medication
- High risk of eating disorders identified by the Eating Disorder Diagnostic Scale (EDDS)
- Severe psychiatric disorders or psychotropic medication use
- Pregnancy, lactation, or planned pregnancy within 6 months
- Allergy to CGM adhesive or hydrogel, or active skin disease affecting sensor wear
- Professional athletes (high-intensity physical activity ≥ 5 times/week, ≥ 60 min/session)
- Weight change > 5% of initial body weight within the past 3 months
- Participation in other commercial or clinical weight-loss programs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of Individual Glycemic Response Based on CGM Wearable Devices in Weight and Body Composition Management Among College Students
This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students. All data for this analysis were retrospectively retrieved from the archived records of a randomized controlled trial conducted at He University, in which 60 students (body mass index [BMI] ≥ 24 kg/m² or elevated body fat percentage) had worn CGM sensors for 4 weeks. The archived records show that the exposed group (n = 30) had received individualized dietary guidance generated from their own glucose responses, including structured CGM reports, meal composition and eating-order advice, and standardized feedback, whereas the non-exposed group (n = 30) had worn CGM without receiving any dietary guidance. One non-exposed participant was excluded from this retrospective analysis for missing primary outcome data, leaving 59 participants for analysis. The archived dataset contains body composition (weight, body mass index [BMI], body fat mass, percent body fat, skeletal muscle mass, visceral fat level) and eating behavior records at Day 0, Day 28, and Day 90. This analysis examines whether the 4-week intervention produced sustained, fat-mass-driven improvements in body composition and whether changes in eating behavior mediated these effects.
Read the detailed description
Background: continuous glucose monitoring (CGM) technology is expanding from diabetes care to weight management in healthy populations. Individualized glycemic response-guided dietary management may improve weight loss efficiency, but whether a brief 4-week intervention produces sustained body composition benefits remains unclear.
Design: This is a retrospective analysis of data collected in a two-arm, parallel-group randomized controlled trial conducted at He University, Shenyang, China. No new intervention was administered and no new measurements were performed in the present study; all data were retrospectively extracted from existing archived records. Participants were classified into two cohorts according to the exposure documented in the archived data of the parent trial. The archived records document that 60 overweight or obese university students (aged 18-25 years) had been randomized 1:1 by a random number table in the parent trial, and that both groups had worn the GX-01S continuous glucose monitoring system for 4 weeks (28 days). The archived records show that the exposed group had received an individualized glycemic response-guided dietary intervention: weeks 1-2 served as a dietary behavior observation period (CGM glucose profiles and electronic food diaries), and weeks 3-4 comprised the individualized intervention, including structured CGM reports (glucose trend graphs, traffic-light food lists, individually glucose-sensitive time windows), dietary guidance on meal composition and eating order, and standardized researcher feedback. The archived records show that the non-exposed group had worn CGM without dietary guidance; CGM data were visible during weeks 1-2 and blinded during weeks 3-4.
Assessments: The archived dataset contains body composition measurements recorded with the InBody 120 bioelectrical impedance analyzer at Day 0 (baseline), Day 28 (end of the 4-week period), and Day 90 (follow-up), together with Dutch Eating Behavior Questionnaire (DEBQ) records at the same three timepoints. All values were retrospectively extracted; no additional measurement was performed for this study.
Outcomes: Primary outcomes of the parent study were time above range (TAR) change and body weight change, both derived from the archived records. This analysis focuses on body composition outcomes: weight, body mass index (BMI), percent body fat, body fat mass, skeletal muscle mass, visceral fat level, and segmental body fat across five body compartments, together with exploratory mediation analyses testing whether DEBQ subscale changes (restrained, emotional, and external eating) mediated the intervention effect.
Ethics: The parent study was approved by the Institutional Ethics Committee of He University, and all participants provided written informed consent. For this retrospective analysis of anonymized data, the ethics committee approved a waiver of renewed informed consent.
- Conditions
- Overweight , Obesity, Weight Loss
- Keywords
- continuous glucose monitoring, personalized nutrition, body composition, eating behavior, university students, retrospective study
- Medical subject headings
- Overweight, Obesity, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed (n=30) | Participants whose archived records from the parent trial indicate that they had received a 4-week individualized glycemic response-guided dietary intervention based on continuous glucose monitoring (CGM) data: dietary behavior observation during weeks 1-2, followed by structured CGM reports, dietary guidance on meal composition and eating order, and standardized researcher feedback during weeks 3-4. | |
| Non-exposed (n=29) | Participants whose archived records from the parent trial indicate that they had worn the CGM system for 4 weeks without receiving dietary guidance or feedback. CGM data were visible during weeks 1-2 and blinded during weeks 3-4. Participants maintained their usual diet and lifestyle. One of the 30 non-exposed participants enrolled in the parent trial was excluded from this retrospective analysis for missing primary outcome data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time above range (TAR)
Change in the percentage of time above the target glucose range recorded in the archived CGM dataset. Unit of Measure: Percent of time (%).
Measured: Data recorded at baseline, Day 14, and Day 28
Body weight
Change in body weight recorded in the archived InBody 120 dataset. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Secondary outcomes (31)
Body fat mass
Change in total body fat mass derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Body mass index (BMI)
Change in body mass index, calculated as body weight in kilograms divided by the square of body height in meters, derived from the archived InBody 120 records. Unit of Measure: Kilogram per square meter (kg/m²).
Measured: Data recorded at Day 0, Day 28, and Day 90
Percent body fat
Change in body fat percentage, calculated as body fat mass divided by total body weight, derived from the archived InBody 120 records. Unit of Measure: Percent (%).
Measured: Data recorded at Day 0, Day 28, and Day 90
Skeletal muscle mass
Change in skeletal muscle mass derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Visceral fat level
Change in visceral fat level derived from the archived InBody 120 records. Scale range: minimum 1, maximum 20; higher levels indicate greater visceral adiposity (worse). Unit of Measure: InBody visceral fat level (unitless scale, 1-20).
Measured: Data recorded at Day 0, Day 28, and Day 90
Waist circumference
Change in waist circumference derived from the archived anthropometric records. Unit of Measure: Centimeter (cm).
Measured: Data recorded at Day 0, Day 28, and Day 90
Hip circumference
Change in hip circumference derived from the archived anthropometric records. Unit of Measure: Centimeter (cm).
Measured: Data recorded at Day 0, Day 28, and Day 90
Waist-hip ratio
Change in waist-hip ratio, calculated as waist circumference divided by hip circumference, derived from the archived anthropometric records. Unit of Measure: Ratio (unitless).
Measured: Data recorded at Day 0, Day 28, and Day 90
Time in range (TIR)
Change in the percentage of time within the target glucose range derived from the archived CGM records. Unit of Measure: Percent of time (%).
Measured: Data recorded from Day 0 to Day 28
Average glucose (AG)
Change in average glucose derived from the archived CGM records. Unit of Measure: Millimole per liter (mmol/L).
Measured: Data recorded from Day 0 to Day 28
Coefficient of variation (CV)
Change in the coefficient of variation of glucose derived from the archived CGM records. Unit of Measure: Percent (%).
Measured: Data recorded from Day 0 to Day 28
DEBQ restrained eating subscale
Change in the restrained eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency toward restrained eating; in this study, increases in this score were considered favorable (better dietary self-regulation). Unit of Measure: Subscale score (1-5).
Measured: Data recorded at Day 0, Day 28, and Day 90
DEBQ emotional eating subscale
Change in the emotional eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency to eat in response to negative emotions; in this weight-management context, higher scores are considered unfavorable (worse outcome). Unit of Measure: Subscale score (1-5).
Measured: Data recorded at Day 0, Day 28, and Day 90
DEBQ external eating subscale
Change in the external eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency to eat in response to external food cues; in this weight-management context, higher scores are considered unfavorable (worse outcome). Unit of Measure: Subscale score (1-5).
Measured: Data recorded at Day 0, Day 28, and Day 90
Eating Disorder Diagnostic Scale (EDDS) score
Change in the Eating Disorder Diagnostic Scale (EDDS) symptom composite score derived from the archived records. Scale range: minimum 0, maximum 227; higher scores indicate more severe eating disorder symptoms (worse outcome). Unit of Measure: Score (0-227).
Measured: Data recorded at Day 0, Day 28, and Day 90
Pittsburgh Sleep Quality Index (PSQI) score
Change in the Pittsburgh Sleep Quality Index (PSQI) global score derived from the archived records. Scale range: minimum 0, maximum 21; higher scores indicate poorer sleep quality (worse outcome). Unit of Measure: Score (0-21).
Measured: Data recorded at Day 0, Day 28, and Day 90
Perceived Stress Scale (PSS-10) score
Change in the Perceived Stress Scale (PSS-10) total score derived from the archived records. Scale range: minimum 0, maximum 40; higher scores indicate greater perceived stress (worse outcome). Unit of Measure: Score (0-40).
Measured: Data recorded at Day 0, Day 28, and Day 90
Traditional Chinese Medicine (TCM) balanced constitution score
Change in the balanced constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate a more balanced constitution (better outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM qi-deficiency constitution score
Change in the qi-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM yang-deficiency constitution score
Change in the yang-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM yin-deficiency constitution score
Change in the yin-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM phlegm-dampness constitution score
Change in the phlegm-dampness constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM damp-heat constitution score
Change in the damp-heat constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM blood-stasis constitution score
Change in the blood-stasis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM qi-stagnation constitution score
Change in the qi-stagnation constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
TCM special diathesis constitution score
Change in the special diathesis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Measured: Data recorded at Day 0, Day 28, and Day 90
Right arm fat mass
Change in body fat mass of the right arm derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Left arm fat mass
Change in body fat mass of the left arm derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Trunk fat mass
Change in body fat mass of the trunk derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Right leg fat mass
Change in body fat mass of the right leg derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Left leg fat mass
Change in body fat mass of the left leg derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Measured: Data recorded at Day 0, Day 28, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Jun 2026
- Primary completion30 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Li, MD, Principal investigator, He University, Shenyang, Liaoning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818005
- Sponsor's protocol ID
- IRB(2026)K005.01
- Acronym
- RCSOGRABCICS
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Individual Glycemic Response Based on CGM Wearable Devices in Weight and Body Composition Management Among College Students
- ClinicalTrials.gov ID
- NCT07818005
- Acronym / sponsor ID
- RCSOGRABCICS / IRB(2026)K005.01
- Conditions
- Overweight , Obesity, Weight Loss
- Keywords
- continuous glucose monitoring, personalized nutrition, body composition, eating behavior, university students, retrospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 27 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 14 Sep 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.
This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students. All data for this analysis were retrospectively retrieved from the archived records of a randomized controlled trial conducted at He University, in which 60 students (body mass index [BMI] ≥ 24 kg/m² or elevated body fat percentage) had worn CGM sensors for 4 weeks. The archived records show that the exposed group (n = 30) had received individualized dietary guidance generated from their own glucose responses, including structured CGM reports, meal composition and eating-order advice, and standardized feedback, whereas the non-exposed group (n = 30) had worn CGM without receiving any dietary guidance. One non-exposed participant was excluded from this retrospective analysis for missing primary outcome data, leaving 59 participants for analysis. The archived dataset contains body composition (weight, body mass index [BMI], body fat mass, percent body fat, skeletal muscle mass, visceral fat level) and eating behavior records at Day 0, Day 28, and Day 90. This analysis examines whether the 4-week intervention produced sustained, fat-mass-driven improvements in body composition and whether changes in eating behavior mediated these effects.
Detailed description
Background: continuous glucose monitoring (CGM) technology is expanding from diabetes care to weight management in healthy populations. Individualized glycemic response-guided dietary management may improve weight loss efficiency, but whether a brief 4-week intervention produces sustained body composition benefits remains unclear.
Design: This is a retrospective analysis of data collected in a two-arm, parallel-group randomized controlled trial conducted at He University, Shenyang, China. No new intervention was administered and no new measurements were performed in the present study; all data were retrospectively extracted from existing archived records. Participants were classified into two cohorts according to the exposure documented in the archived data of the parent trial. The archived records document that 60 overweight or obese university students (aged 18-25 years) had been randomized 1:1 by a random number table in the parent trial, and that both groups had worn the GX-01S continuous glucose monitoring system for 4 weeks (28 days). The archived records show that the exposed group had received an individualized glycemic response-guided dietary intervention: weeks 1-2 served as a dietary behavior observation period (CGM glucose profiles and electronic food diaries), and weeks 3-4 comprised the individualized intervention, including structured CGM reports (glucose trend graphs, traffic-light food lists, individually glucose-sensitive time windows), dietary guidance on meal composition and eating order, and standardized researcher feedback. The archived records show that the non-exposed group had worn CGM without dietary guidance; CGM data were visible during weeks 1-2 and blinded during weeks 3-4.
Assessments: The archived dataset contains body composition measurements recorded with the InBody 120 bioelectrical impedance analyzer at Day 0 (baseline), Day 28 (end of the 4-week period), and Day 90 (follow-up), together with Dutch Eating Behavior Questionnaire (DEBQ) records at the same three timepoints. All values were retrospectively extracted; no additional measurement was performed for this study.
Outcomes: Primary outcomes of the parent study were time above range (TAR) change and body weight change, both derived from the archived records. This analysis focuses on body composition outcomes: weight, body mass index (BMI), percent body fat, body fat mass, skeletal muscle mass, visceral fat level, and segmental body fat across five body compartments, together with exploratory mediation analyses testing whether DEBQ subscale changes (restrained, emotional, and external eating) mediated the intervention effect.
Ethics: The parent study was approved by the Institutional Ethics Committee of He University, and all participants provided written informed consent. For this retrospective analysis of anonymized data, the ethics committee approved a waiver of renewed informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed (n=30) | – | –Participants whose archived records from the parent trial indicate that they had received a 4-week individualized glycemic response-guided dietary intervention based on continuous glucose monitoring (CGM) data: dietary behavior observation during weeks 1-2, followed by structured CGM reports, dietary guidance on meal composition and eating order, and standardized researcher feedback during weeks 3-4. |
| Non-exposed (n=29) | – | –Participants whose archived records from the parent trial indicate that they had worn the CGM system for 4 weeks without receiving dietary guidance or feedback. CGM data were visible during weeks 1-2 and blinded during weeks 3-4. Participants maintained their usual diet and lifestyle. One of the 30 non-exposed participants enrolled in the parent trial was excluded from this retrospective analysis for missing primary outcome data. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overweight and obese university students (aged 18-25 years) at He University, Shenyang, Liaoning, China, whose records are contained in the archived dataset of a randomized controlled trial of a 4-week continuous glucose monitoring (CGM)-guided personalized dietary intervention. Participants had a body mass index (BMI) ≥ 24 kg/m² or elevated body fat percentage (≥ 25% in men, ≥ 32% in women) and self-reported at least two unhealthy eating behaviors. Of the 60 participants enrolled in the parent trial (30 per group), 59 were included in this retrospective analysis (30 exposed, 29 non-exposed); one non-exposed participant was excluded for missing primary outcome data. All participants were free of diabetes, prediabetes, and other exclusion conditions defined in the study protocol.
Key inclusion criteria (16 listed)
- University students aged 18 to 25 years
- Body mass index (BMI) ≥ 24.0 kg/m², or body fat percentage ≥ 25% (male) / ≥ 32% (female)
- Self-reported presence of at least two unhealthy eating behaviors
- Written informed consent
- Exclusion Criteria:• Obesity due to endocrine diseases (e.g., Cushing's syndrome, hypothyroidism, hypothalamic obesity) or genetic syndromes
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time above range (TAR)
Time frame: Data recorded at baseline, Day 14, and Day 28
Change in the percentage of time above the target glucose range recorded in the archived CGM dataset. Unit of Measure: Percent of time (%).
Body weight
Time frame: Data recorded at Day 0, Day 28, and Day 90
Change in body weight recorded in the archived InBody 120 dataset. Unit of Measure: Kilogram (kg).
31 secondary outcomes
Body fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Body mass index (BMI)
Time frame: Data recorded at Day 0, Day 28, and Day 90
Percent body fat
Time frame: Data recorded at Day 0, Day 28, and Day 90
Skeletal muscle mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Visceral fat level
Time frame: Data recorded at Day 0, Day 28, and Day 90
Waist circumference
Time frame: Data recorded at Day 0, Day 28, and Day 90
Hip circumference
Time frame: Data recorded at Day 0, Day 28, and Day 90
Waist-hip ratio
Time frame: Data recorded at Day 0, Day 28, and Day 90
Time in range (TIR)
Time frame: Data recorded from Day 0 to Day 28
Average glucose (AG)
Time frame: Data recorded from Day 0 to Day 28
Coefficient of variation (CV)
Time frame: Data recorded from Day 0 to Day 28
DEBQ restrained eating subscale
Time frame: Data recorded at Day 0, Day 28, and Day 90
DEBQ emotional eating subscale
Time frame: Data recorded at Day 0, Day 28, and Day 90
DEBQ external eating subscale
Time frame: Data recorded at Day 0, Day 28, and Day 90
Eating Disorder Diagnostic Scale (EDDS) score
Time frame: Data recorded at Day 0, Day 28, and Day 90
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Data recorded at Day 0, Day 28, and Day 90
Perceived Stress Scale (PSS-10) score
Time frame: Data recorded at Day 0, Day 28, and Day 90
Traditional Chinese Medicine (TCM) balanced constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM qi-deficiency constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM yang-deficiency constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM yin-deficiency constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM phlegm-dampness constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM damp-heat constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM blood-stasis constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM qi-stagnation constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
TCM special diathesis constitution score
Time frame: Data recorded at Day 0, Day 28, and Day 90
Right arm fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Left arm fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Trunk fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Right leg fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Left leg fat mass
Time frame: Data recorded at Day 0, Day 28, and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jun Li, MD principal investigator
He University, Shenyang, Liaoning, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight , Obesity and Weight Loss, run by He Eye Hospital at 1 site 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 16 inclusion and 0 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: finished, as of the sponsor's last update on 14 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time above range (TAR) (time frame: Data recorded at baseline, Day 14, and Day 28). The study lists 2 primary outcomes in all. 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 14 Sep 2026.