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RECRUITING
NCT07618663
NA

Personalized Meal Timing and Walking Based on Glucose Patterns in Adults With Prediabetes

Sponsor: Shifa International Hospital

View on ClinicalTrials.gov

Summary

This study will test whether glucose sensor data can be used to identify the time of day when adults with prediabetes are most likely to have high blood sugar after meals. Participants will first wear a continuous glucose monitor and wrist activity monitor and record meal times for 10 days. These data will be used to classify each participant's personal "glycemic vulnerability window," such as morning, evening, or generally variable patterns. Participants will then be randomly assigned to either personalized meal timing plus a short walk after their most vulnerable meal, or to an attention-matched control group receiving sleep hygiene and general step-count advice. The main outcome will be the change in post-meal glucose exposure during each participant's vulnerable window after 4 weeks.

Official title: CGM-Phenotyped Circadian Glycemic Vulnerability Windows to Personalize Meal Timing and Postprandial Activity in Prediabetes : A Randomized Controlled Trial

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-06-01

Completion Date

2026-07-15

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

Phenotype-Guided Meal Timing and Postprandial Walking

Participants randomized to this arm will receive personalized lifestyle guidance based on their CGM-derived circadian glycemic vulnerability phenotype. During the 10-day run-in period, continuous glucose monitoring, wrist actigraphy, and timestamped meal-photo logs will be used to identify the time window in which each participant has the greatest postprandial glucose exposure. Participants will be advised to shift their highest glycemic-load meal away from their highest-vulnerability window and toward their lowest-vulnerability window where feasible. They will also be instructed to perform a 10-minute brisk walk within 30 minutes after the meal occurring in their highest-vulnerability window on at least 5 days per week. The intervention will be delivered through structured dietitian counseling sessions and brief weekly check-in calls. No calorie restriction, prescribed macronutrient diet, or weight-loss target will be imposed.

BEHAVIORAL

Sleep Hygiene and Step-Count Advice

Participants randomized to the active comparator arm will receive standardized sleep hygiene and general physical activity guidance matched for contact time with the intervention arm. Sleep hygiene advice will include maintaining regular sleep and wake times, aiming for adequate sleep duration, and reducing screen exposure before bedtime. Participants will also be advised to increase their average daily step count by approximately 10% above their run-in baseline, with steps distributed freely throughout the day. This arm will not include any advice on meal timing, carbohydrate timing, glycemic vulnerability windows, or postprandial walking. The intervention will be delivered through structured dietitian counseling sessions and brief weekly check-in calls.

Locations (1)

Shifa International hospital

Lahore, Shaikhupura, Pakistan