Individual Stress and Weight LossINSTANTNCT06668259
Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention
An observational study of Individual Stress and Weight Loss, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individual Stress and Weight Loss
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2025to 28 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state will be eligible to participate
Who may be able to join
- Enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity.
- Must own a smart phone and be willing to download the mobile application to receive text messages
Who cannot join
- Report a current medical condition or treatment for a medical condition that could affect body weight.
- Current psychological condition (including clinically diagnosed depression) that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- Is not fluent in writing or speaking the English language.
- Mobility limitations so they are unable to perform physical activity.
- Family member currently enrolled in the study or has a family member that previously participated in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fairway North
Fairway, Kansas, 66205
Kirmayer Fitness Center
Kansas City, Kansas, 66103
About this study
Official title: Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study
Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program
- Conditions
- Individual Stress and Weight Loss
- Keywords
- stress, weight loss, EMA, weight gain, cortisol, surveys
- Medical subject headings
- Weight Loss, Weight Gain
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
Weight will be measured using a digital scale in kg to the nearest 0.1 kg.
Measured: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Physical Activity
Physical activity will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive days. Accelerometer will only be removed for water-based activities.
Measured: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Sleep
Sleep will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive nights.
Measured: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Stress-related Concepts (EMA)
Stress-related concepts are measured by surveys of daily coping ability, stress, and affect assessed by Ecological Momentary Assessments (EMA). For daily coping, participants will be asked about their ability to cope with stress, on a scale from 0-10 with 10 indicating completely able to cope. For stress participants will be asked about their current stress level, on a scale from 0-10 with 10 indicating the highest stress. Affect will be assessed through 5 questions related to their current feeling of happiness, frustration, stress, anger, sadness, and calm/relaxed.
Measured: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Secondary outcomes (1)
Cortisol (mg/mL)
Collected via salivary collection methods
Measured: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start20 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Individual Stress and Weight LossStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Chelsea L. Kracht, PhD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668259
- Sponsor's protocol ID
- STUDY00160436
- Other IDs
- 5P20GM144269-03
- Acronym
- INSTANT
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data will be shared with controlled access in NIDDK Central Repository for general research use
Publications
Kracht CL, Davis AM, Apte U, Snodgrass M, Collier TY, Honas JJ, Jakicic JM. Intensive longitudinal assessment of stress and stress-related concepts across a weight loss program: Protocol for a longitudinal ecological momentary assessment study. PLoS One. 2026 Sep 10;21(9):e0357572. doi: 10.1371/journal.pone.0357572. eCollection 2026.
PubMed 42721199
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study
- ClinicalTrials.gov ID
- NCT06668259
- Acronym / sponsor ID
- INSTANT / STUDY00160436
- Conditions
- Individual Stress and Weight Loss
- Keywords
- stress, weight loss, EMA, weight gain, cortisol, surveys
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 31 Oct 2024 (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.
Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state will be eligible to participate
Key inclusion criteria (2 listed)
- Enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity.
- Must own a smart phone and be willing to download the mobile application to receive text messages
Key exclusion criteria (5 listed)
- Report a current medical condition or treatment for a medical condition that could affect body weight.
- Current psychological condition (including clinically diagnosed depression) that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- Is not fluent in writing or speaking the English language.
- Mobility limitations so they are unable to perform physical activity.
- Family member currently enrolled in the study or has a family member that previously participated in the study.
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 (kg)
Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Weight will be measured using a digital scale in kg to the nearest 0.1 kg.
Physical Activity
Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Physical activity will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive days. Accelerometer will only be removed for water-based activities.
Sleep
Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Sleep will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive nights.
Stress-related Concepts (EMA)
Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Stress-related concepts are measured by surveys of daily coping ability, stress, and affect assessed by Ecological Momentary Assessments (EMA). For daily coping, participants will be asked about their ability to cope with stress, on a scale from 0-10 with 10 indicating completely able to cope. For stress participants will be asked about their current stress level, on a scale from 0-10 with 10 indicating the highest stress. Affect will be assessed through 5 questions related to their current feeling of happiness, frustration, stress, anger, sadness, and calm/relaxed.
1 secondary outcome
Cortisol (mg/mL)
Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
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 13 Aug 2026.
- Derived from this study: PubMed 42721199Kracht CL, Davis AM, Apte U, Snodgrass M, Collier TY, Honas JJ, Jakicic JM. Intensive longitudinal assessment of stress and stress-related concepts across a weight loss program: Protocol for a longitudinal ecological momentary assessment study. PLoS One. 2026 Sep 10;21(9):e0357572. doi: 10.1371/journal.pone.0357572. eCollection 2026.
- Individual participant dataSharing planned: Yes. Clinical data will be shared with controlled access in NIDDK Central Repository for general research use
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Individual Stress and Weight Loss, run by University of Kansas Medical Center at 2 sites 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (kg) (time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668259, which also lists 1 linked publication.
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 13 Aug 2026.