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Enrolling by invitationNCT03840733Updated Dec 19, 2025

Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

An observational study in Obesity and Weight Change, Body, sponsored by University of Colorado, Denver. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

A total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.In this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. Only participants who completed the behavioral weight loss intervention will be enrolled in this study. Participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.

02

Conditions studied

  • Obesity
  • Weight Change, Body

Keywords

  • physical activity
  • sleep
  • eating patterns
  • energy expenditure
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 60 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Browse University of Colorado, Denver studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Participants from NCT01985568 or NCT03411356

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

06

What researchers measure

Primary outcomes

  1. Weight Change

    Change in body weight (kg)

    Time frame: Baseline to 54 months

  2. Weight Maintenance

    Change in body weight (kg)

    Time frame: 18 months to 54 months

  3. Fat Mass Change

    Change in Fat Mass (kg)

    Time frame: Baseline to 54 months

  4. Fat Free Mass Change

    Change in Fat Free Mass (kg)

    Time frame: Baseline to 54 months

  5. Fat Mass Maintenance

    Change in Fat Mass (kg)

    Time frame: 18 months to 54 months

  6. Fat Free Mass Maintenance

    Change in Fat Free Mass (kg)

    Time frame: 18 months to 54 months

Secondary outcomes

  1. Change in Physical Activity Patterns

    Physical activity patterns as measured by SenseWear armband (min/day)

    Time frame: 0, 6, 12, 18, 24, 54 month

  2. Physical Activity Patterns

    Physical activity patterns as measured by ActivPAL, Actigraph (min/day)

    Time frame: 54 month

  3. Change in Sleep

    Sleep patterns as measured by SenseWear armband (h/day)

    Time frame: 0, 6, 12, 18, 24, 54 month

  4. Sleep Patterns

    Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)

    Time frame: 54 month

  5. Change in Energy Intake

    Energy Intake patterns as measured by 3 day food record (kcal/day

    Time frame: 0, 6, 12, 18, 54 month

  6. Energy Intake Patterns

    Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)

    Time frame: 54 month

  7. Resting Metabolic Rate

    Resting metabolic rate as measured using indirect calorimetry (kcal/day)

    Time frame: 54 month

  8. Total Daily Energy Expenditure

    Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)

    Time frame: 54 month

  9. Physical Activity Energy Expenditure

    Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)

    Time frame: 54 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Jan 2026, 84 months after the start.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 84 months is above that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2019
First posted
Feb 15, 2019
StartActual
Jan 7, 2019
Primary completionEst.
Jan 2026
CompletionEst.
Jan 2026
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03840733
Lead sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Jan 7, 2019
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Dec 19, 2025

Study contacts

Seth A Creasy, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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