Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Obesity Clinical Trial

Official title:

Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03840733
• Other study ID #: 18-1319
• Secondary ID: K01HL145023
• Status: Enrolling by invitation
• Start date: January 7, 2019
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Obesity
• Weight Change, Body
• Weight Loss

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Change in body weight (kg)	Baseline to 54 months
Primary	Weight Maintenance	Change in body weight (kg)	18 months to 54 months
Primary	Fat Mass Change	Change in Fat Mass (kg)	Baseline to 54 months
Primary	Fat Free Mass Change	Change in Fat Free Mass (kg)	Baseline to 54 months
Primary	Fat Mass Maintenance	Change in Fat Mass (kg)	18 months to 54 months
Primary	Fat Free Mass Maintenance	Change in Fat Free Mass (kg)	18 months to 54 months
Secondary	Change in Physical Activity Patterns	Physical activity patterns as measured by SenseWear armband (min/day)	0, 6, 12, 18, 24, 54 month
Secondary	Physical Activity Patterns	Physical activity patterns as measured by ActivPAL, Actigraph (min/day)	54 month
Secondary	Change in Sleep	Sleep patterns as measured by SenseWear armband (h/day)	0, 6, 12, 18, 24, 54 month
Secondary	Sleep Patterns	Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)	54 month
Secondary	Change in Energy Intake	Energy Intake patterns as measured by 3 day food record (kcal/day	0, 6, 12, 18, 54 month
Secondary	Energy Intake Patterns	Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)	54 month
Secondary	Resting Metabolic Rate	Resting metabolic rate as measured using indirect calorimetry (kcal/day)	54 month
Secondary	Total Daily Energy Expenditure	Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)	54 month
Secondary	Physical Activity Energy Expenditure	Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)	54 month