NCT03336411

A Personalized Diet Study to Reduce Glycemic Exposure

Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study.

Conditions

• Pre-diabetes
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	mHealth	Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.
BEHAVIORAL	Personalized mHealth	Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.

Timeline

• Start date: 2017-12-12
• Primary completion: 2021-04-01
• Completion: 2021-10-27
• First posted: 2017-11-08
• Last updated: 2022-03-10

Locations

1 site across 1 country: United States