Recruiting NCT06668259
Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Individual Stress and Weight Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study
Overview
Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program
Primary outcome measures
- Weight (kg) [Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks]
- Physical Activity [Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks]
- Sleep [Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks]
- Stress-related Concepts (EMA) [Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks]
Secondary outcome measures (1)
- Cortisol (mg/mL) [Time frame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Fairway North — Fairway
- Kirmayer Fitness Center — Kansas City
Identifiers
NCT: NCT06668259 · STUDY00160436 · 5P20GM144269-03