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

Recruiting

• Conditions: Individual Stress and Weight Loss

• Registration Number: NCT06668259
• Lead Sponsor: University of Kansas Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Status Verified: 2025-03
• Study Start: 2025-03-07
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2028-03-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Enrolled in a KUMC 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 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.
• Clinically diagnosed depression.
• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight (kg)	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	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	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)	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 Outcome Measures

Name	Time	Method
Cortisol (mg/mL)	0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks	Collected via salivary collection methods

Trial Locations

Locations (2)

Fairway North; 🇺🇸 Fairway, Kansas, United States

Kirmayer Fitness Center; 🇺🇸 Kansas City, Kansas, United States