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

Sponsor
Shifa International Hospital
Study ID
NCT07618663
Status
Recruiting
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Conditions

  • Prediabetes
  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
  • Prediabetes or Diabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Phenotype-Guided Meal Timing and Postprandial Walking — BEHAVIORAL
    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.
  • Sleep Hygiene and Step-Count Advice — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Phenotype-Guided Meal Timing and Postprandial Walking
    Participants will receive personalized lifestyle guidance based on their CGM-derived circadian glycemic vulnerability phenotype. They will be advised to shift their highest glycemic-load meal away from their highest-vulnerability window and toward their lowest-vulnerability window, and to perform a 10-minute brisk walk within 30 minutes after the meal occurring in their highest-vulnerability window.
  • Active Comparator: Attention-Matched Sleep Hygiene and Step-Count Advice
    Participants will receive standardized sleep hygiene advice and general step-count guidance matched for contact time with the intervention group. They will not receive meal-timing advice, carbohydrate-timing advice, or postprandial walking instructions.

Primary Outcome Measure

Change in Vulnerable-Window Postprandial Glucose Incremental Area Under the Curve [ Time Frame: Baseline run-in period to Week 4, unit of measure: mg/dL·min ]

Central Contacts

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