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NCT Number: NCT06668259

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

Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program

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Key information

Conditions

Individual Stress and Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fairway North, Fairway, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Cortisol (mg/mL)

    Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks

    Collected via salivary collection methods

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Kracht

CONTACT

[email protected]

913-588-1655

Taylor Gatson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Acronym: INSTANT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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