Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention (INSTANT)

November 18, 2025 updated by: Chelsea L. Kracht, PhD, University of Kansas Medical Center

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Active, not recruiting
        • Fairway North
      • Kansas City, Kansas, United States, 66103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
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.
0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
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.
0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
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.
0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol (mg/mL)
Time Frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Collected via salivary collection methods
0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00160436
  • 5P20GM144269-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical data will be shared with controlled access in NIDDK Central Repository for general research use

IPD Sharing Time Frame

Beginning 1 year after publication with no end date.

IPD Sharing Access Criteria

Data will be stored in the NIDDK Central Repository data repository. Other requests for data and further information can be made to the PI, who will follow appropriate channels to distribute the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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