Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Weight Change, Body

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants previously enrolled in an 18-month behavioral weight loss intervention at the University of Colorado Anschutz Medical Campus. (NCT01985568)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants from NCT01985568 or NCT03411356; All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Change in body weight (kg)	Baseline to 54 months
Weight Maintenance	Change in body weight (kg)	18 months to 54 months
Fat Mass Change	Change in Fat Mass (kg)	Baseline to 54 months
Fat Free Mass Change	Change in Fat Free Mass (kg)	Baseline to 54 months
Fat Mass Maintenance	Change in Fat Mass (kg)	18 months to 54 months
Fat Free Mass Maintenance	Change in Fat Free Mass (kg)	18 months to 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity Patterns	Physical activity patterns as measured by SenseWear armband (min/day)	0, 6, 12, 18, 24, 54 month
Physical Activity Patterns	Physical activity patterns as measured by ActivPAL, Actigraph (min/day)	54 month
Change in Sleep	Sleep patterns as measured by SenseWear armband (h/day)	0, 6, 12, 18, 24, 54 month
Sleep Patterns	Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)	54 month
Change in Energy Intake	Energy Intake patterns as measured by 3 day food record (kcal/day	0, 6, 12, 18, 54 month
Energy Intake Patterns	Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)	54 month
Resting Metabolic Rate	Resting metabolic rate as measured using indirect calorimetry (kcal/day)	54 month
Total Daily Energy Expenditure	Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)	54 month
Physical Activity Energy Expenditure	Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)	54 month

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Seth A Creasy, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; sleep; energy expenditure; eating patterns
• Additional Relevant MeSH Terms: Weight Loss; Body Weight; Body Weight Changes
• Other Study ID Numbers: 18-1319; K01HL145023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No