Glucose, Activity, Diet, & Sleep Assessment Study (GLADS)

September 18, 2023 updated by: Blandine Laferrere, Columbia University

GLADS Study: Glucose, Activity, Diet, & Sleep Assessment Study

GLADS is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. New technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. The study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Russ Berrie Medical Science Pavilion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult men and women willing to record food intake with their smartphone, complete online questionnaires, and wear body sensors to measure physical activity, sleep, and glucose.

Description

Inclusion Criteria:

  • Age: 18-75 y old
  • In possession of a smartphone
  • English speaking
  • Live in New York City metro area

Exclusion Criteria:

  • Active food intake disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 2 weeks
Mean, fasting, post-prandial measured by continuous glucose monitoring
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration
Time Frame: 2 weeks
Measured by actigraphy
2 weeks
Sleep fragmentation
Time Frame: 2 weeks
Measured by actigraphy
2 weeks
Diet composition
Time Frame: 2 weeks
Carbohydrates, fats, proteins assessed by dietary recall
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Blandine Laferrere, MD, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT6779

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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