NCT03840733

Brief Summary

This study is designed as an observational trial. The objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. Outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. In addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

January 7, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

January 29, 2019

Last Update Submit

December 17, 2025

Conditions

Weight Change, BodyObesity

Keywords

physical activitysleepeating patternsenergy expenditure

Outcome Measures

Primary Outcomes (6)

  • Weight Change

    Change in body weight (kg)

    Baseline to 54 months

  • Weight Maintenance

    Change in body weight (kg)

    18 months to 54 months

  • Fat Mass Change

    Change in Fat Mass (kg)

    Baseline to 54 months

  • Fat Free Mass Change

    Change in Fat Free Mass (kg)

    Baseline to 54 months

  • Fat Mass Maintenance

    Change in Fat Mass (kg)

    18 months to 54 months

  • Fat Free Mass Maintenance

    Change in Fat Free Mass (kg)

    18 months to 54 months

Secondary Outcomes (9)

  • Change in Physical Activity Patterns

    0, 6, 12, 18, 24, 54 month

  • Physical Activity Patterns

    54 month

  • Change in Sleep

    0, 6, 12, 18, 24, 54 month

  • Sleep Patterns

    54 month

  • Change in Energy Intake

    0, 6, 12, 18, 54 month

  • +4 more secondary outcomes

Study Arms (1)

Participants from NCT01985568 or NCT03411356

All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356).

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants previously enrolled in an 18-month behavioral weight loss intervention at the University of Colorado Anschutz Medical Campus. (NCT01985568)

You may qualify if:

  • Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or NCT03411356)
  • Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)
  • Capable and willing to give informed consent
  • Possess a smartphone to install and utilize the meal timing application
  • Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days
  • Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes

You may not qualify if:

  • Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)
  • New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)
  • Women who became pregnant after completing the Parent Trial
  • Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

ObesityBody Weight ChangesMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Seth A Creasy, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 15, 2019

Study Start

January 7, 2019

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)