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Enrolling by invitation NCT03840733

Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

— Observational Obesity Weight Change, Body

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: Obesity, Weight Change, Body. Basic parameters: 18 years — 60 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 →

Overview

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.

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.

Primary outcome measures

  • Weight Change [Time frame: Baseline to 54 months]
  • Weight Maintenance [Time frame: 18 months to 54 months]
  • Fat Mass Change [Time frame: Baseline to 54 months]
  • Fat Free Mass Change [Time frame: Baseline to 54 months]
  • Fat Mass Maintenance [Time frame: 18 months to 54 months]
  • Fat Free Mass Maintenance [Time frame: 18 months to 54 months]
Secondary outcome measures (9)
  • Change in Physical Activity Patterns [Time frame: 0, 6, 12, 18, 24, 54 month]
  • Physical Activity Patterns [Time frame: 54 month]
  • Change in Sleep [Time frame: 0, 6, 12, 18, 24, 54 month]
  • Sleep Patterns [Time frame: 54 month]
  • Change in Energy Intake [Time frame: 0, 6, 12, 18, 54 month]
  • Energy Intake Patterns [Time frame: 54 month]
  • Resting Metabolic Rate [Time frame: 54 month]
  • Total Daily Energy Expenditure [Time frame: 54 month]
  • Physical Activity Energy Expenditure [Time frame: 54 month]

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

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 · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT03840733 · 18-1319 · K01HL145023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗