NCT03129581

Brief Summary

The investigators are interested in how time-restricted feeding will impact weight, sleep duration and efficacy, and activity levels in obese adults. Significant advances in digital mobile technology allow detailed measures of an individual's habits, permitting the opportunity for personalized dietary and lifestyle recommendations. This is especially relevant as time-restricted feeding appears to promote weight loss independent of calorie intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to a time-based perspective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

April 17, 2017

Last Update Submit

September 21, 2022

Conditions

ObesityDiet Modification

Keywords

obesity, diet, sleep activity

Outcome Measures

Primary Outcomes (1)

  • Weight

    Change in weight (kg) from baseline to study conclusion

    12 weeks

Secondary Outcomes (1)

  • Body composition

    12 weeks

Study Arms (2)

Time Restricted

ACTIVE COMPARATOR

This group will receive dietary counseling.

Behavioral: Dietary Counseling

Time Unrestricted

NO INTERVENTION

This group will not receive dietary counseling.

Interventions

Dietary CounselingBEHAVIORAL

Counseling to only eat during a restricted amount of time.

Time Restricted

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • BMI ≥ 25
  • Stable sleep and work schedule
  • Owns a smart phone
  • Capable of giving informed consent

You may not qualify if:

  • Pregnant
  • Nursing
  • Anticipation of pregnancy during the course of the study
  • Clinically significant medical issues as determined by the study clinician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.

    PMID: 34282646DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lisa Chow, MD

    University of Minnesota, Division of Diabetes, Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, non-blinded, behavioral intervention pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 26, 2017

Study Start

September 1, 2017

Primary Completion

May 31, 2019

Study Completion

July 12, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)