Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students

NCT07818005 | Completed

• 1 other identifier: IRB(2026)K005.01
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight , Obesity; Weight Loss

Keywords

continuous glucose monitoring; personalized nutrition; body composition; eating behavior; university students; retrospective study

Outcome Measures

Primary Outcomes (2)

• 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 (%).

  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).

  Data recorded at Day 0, Day 28, and Day 90

Secondary Outcomes (31)

• Body fat mass

  Data recorded at Day 0, Day 28, and Day 90

• Body mass index (BMI)

  Data recorded at Day 0, Day 28, and Day 90

• Percent body fat

  Data recorded at Day 0, Day 28, and Day 90

• Skeletal muscle mass

  Data recorded at Day 0, Day 28, and Day 90

• Visceral fat level

  Data recorded at Day 0, Day 28, and Day 90

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Polycystic ovary syndrome (PCOS)
• 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

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He University, Shenyang, Liaoning, China

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

Study Officials

• Jun Li, MD

  He University, Shenyang, Liaoning, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 14, 2026
• Study Start: June 27, 2026
• Primary Completion: July 30, 2026
• Study Completion: August 15, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)