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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06668259
Acronym
INSTANT
Enrollment
52
Registered
2024-10-31
Start date
2025-06-20
Completion date
2027-02-28
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individual Stress and Weight Loss

Keywords

stress, weight loss, EMA, weight gain, cortisol, surveys

Brief 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

Interventions

None listed

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Weight (kg)0 Weeks, 6 Weeks, 12 Weeks, and 26 WeeksWeight will be measured using a digital scale in kg to the nearest 0.1 kg.
Physical Activity0 Weeks, 6 Weeks, 12 Weeks, and 26 WeeksPhysical 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.
Sleep0 Weeks, 6 Weeks, 12 Weeks, and 26 WeeksSleep will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive nights.
Stress-related Concepts (EMA)0 Weeks, 6 Weeks, 12 Weeks, and 26 WeeksStress-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.

Secondary

MeasureTime frameDescription
Cortisol (mg/mL)0 Weeks, 6 Weeks, 12 Weeks, and 26 WeeksCollected via salivary collection methods

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026