ObesityNCT03840733
Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes
An observational study of Obesity and Weight Change, Body, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Weight Change, Body
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to Jan 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants previously enrolled in an 18-month behavioral weight loss intervention at the University of Colorado Anschutz Medical Campus. (NCT01985568)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Obesity, Weight Change, Body
- Keywords
- physical activity, sleep, eating patterns, energy expenditure
- Medical subject headings
- Obesity, Body Weight Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants from NCT01985568 or NCT03411356 | All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Change in body weight (kg)
Measured: Baseline to 54 months
Weight Maintenance
Change in body weight (kg)
Measured: 18 months to 54 months
Fat Mass Change
Change in Fat Mass (kg)
Measured: Baseline to 54 months
Fat Free Mass Change
Change in Fat Free Mass (kg)
Measured: Baseline to 54 months
Fat Mass Maintenance
Change in Fat Mass (kg)
Measured: 18 months to 54 months
Fat Free Mass Maintenance
Change in Fat Free Mass (kg)
Measured: 18 months to 54 months
Secondary outcomes (9)
Change in Physical Activity Patterns
Physical activity patterns as measured by SenseWear armband (min/day)
Measured: 0, 6, 12, 18, 24, 54 month
Physical Activity Patterns
Physical activity patterns as measured by ActivPAL, Actigraph (min/day)
Measured: 54 month
Change in Sleep
Sleep patterns as measured by SenseWear armband (h/day)
Measured: 0, 6, 12, 18, 24, 54 month
Sleep Patterns
Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)
Measured: 54 month
Change in Energy Intake
Energy Intake patterns as measured by 3 day food record (kcal/day
Measured: 0, 6, 12, 18, 54 month
Energy Intake Patterns
Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)
Measured: 54 month
Resting Metabolic Rate
Resting metabolic rate as measured using indirect calorimetry (kcal/day)
Measured: 54 month
Total Daily Energy Expenditure
Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)
Measured: 54 month
Physical Activity Energy Expenditure
Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)
Measured: 54 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Jan 2019
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Seth A Creasy, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840733
- Sponsor's protocol ID
- 18-1319
- Other IDs
- K01HL145023
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes
- ClinicalTrials.gov ID
- NCT03840733
- Acronym / sponsor ID
- 18-1319
- Conditions
- Obesity, Weight Change, Body
- Keywords
- physical activity, sleep, eating patterns, energy expenditure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants from NCT01985568 or NCT03411356 | – | –All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants previously enrolled in an 18-month behavioral weight loss intervention at the University of Colorado Anschutz Medical Campus. (NCT01985568)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight Change
Time frame: Baseline to 54 months
Change in body weight (kg)
Weight Maintenance
Time frame: 18 months to 54 months
Change in body weight (kg)
Fat Mass Change
Time frame: Baseline to 54 months
Change in Fat Mass (kg)
Fat Free Mass Change
Time frame: Baseline to 54 months
Change in Fat Free Mass (kg)
Fat Mass Maintenance
Time frame: 18 months to 54 months
Change in Fat Mass (kg)
Fat Free Mass Maintenance
Time frame: 18 months to 54 months
Change in Fat Free Mass (kg)
9 secondary outcomes
Change in Physical Activity Patterns
Time frame: 0, 6, 12, 18, 24, 54 month
Physical Activity Patterns
Time frame: 54 month
Change in Sleep
Time frame: 0, 6, 12, 18, 24, 54 month
Sleep Patterns
Time frame: 54 month
Change in Energy Intake
Time frame: 0, 6, 12, 18, 54 month
Energy Intake Patterns
Time frame: 54 month
Resting Metabolic Rate
Time frame: 54 month
Total Daily Energy Expenditure
Time frame: 54 month
Physical Activity Energy Expenditure
Time frame: 54 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seth A Creasy, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Weight Change, Body, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: Baseline to 54 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.