An observational study in Overweight , Obesity and Weight Loss, sponsored by He Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by He Eye Hospital · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 59 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →He Eye Hospital is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Inclusion Criteria:
Exclusion Criteria:• Obesity due to endocrine diseases (e.g., Cushing's syndrome, hypothyroidism, hypothalamic obesity) or genetic syndromes
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 (%).
Time frame: 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).
Time frame: Data recorded at Day 0, Day 28, and Day 90
Body fat mass
Change in total body fat mass derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Data recorded at Day 0, Day 28, and Day 90
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