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A Personalized Diet Study to Reduce Glycemic Exposure

NCT03336411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2022-03-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Mary Ann Sevick, ScD · NYU Langone Medical Center, Department of Population Health

  • Eran Segal, PhD · Weizmann Institute of Science, Department of Computer Science and Applied Mathematics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2021-04-01
Completion
2021-10-27

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336411 on ClinicalTrials.gov