Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 13, 2019

Keywords

ClinConnect Summary

This is an observational follow-up study looking at people who previously completed an 18-month behavioral weight loss program. Researchers will track these participants for up to about 3 years after the end of that program to see how their weight, body fat, and lean body mass change, and how these changes relate to daily activities, sleep, and eating patterns. The main questions focus on how much weight people lose or keep off from the start of the follow-up to about 54 months, and how well they maintain their fat and lean mass over time. They will also measure resting metabolism and total energy use to see how these factors relate to weight maintenance.

Who can take part: adults roughly aged 18 to 60 who previously joined the parent weight loss study. Eligible participants should be willing to: use a smartphone app to track meal timing, wear activity and sleep monitors for about 28 days, and complete a detailed test of daily energy use that includes urine samples and drinking specially labeled water. Exclusion criteria include anything a clinician would consider unsafe for participation, new medical conditions affecting weight or metabolism, pregnancy after completing the parent trial, and recent use of medications that affect appetite, weight, or sleep. The study is conducted at the University of Colorado Anschutz Medical Campus in Colorado, is not testing a drug or device, and is led by the university with NHLBI support. It is currently enrolling by invitation, with primary completion expected in early 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or NCT03411356)
• • Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)
• • Capable and willing to give informed consent
• • Possess a smartphone to install and utilize the meal timing application
• • Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days
• • Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes
• Exclusion Criteria:
• • Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)
• • New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)
• • Women who became pregnant after completing the Parent Trial
• • Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep