Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Obesity; Weight Change, Body

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03840733

18-1319

K01HL145023 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is designed as an observational trial. The objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. Outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. In addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.

Full description

A total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.In this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. Only participants who completed the behavioral weight loss intervention will be enrolled in this study. Participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Participants from NCT01985568 or NCT03411356

Description:

All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356).