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OpenTrials
Enrolling by Invitation

NCT Number: NCT03840733

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Change, Body

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weight Change

    Time frame: Baseline to 54 months

    Change in body weight (kg)

  2. Weight Maintenance

    Time frame: 18 months to 54 months

    Change in body weight (kg)

  3. Fat Mass Change

    Time frame: Baseline to 54 months

    Change in Fat Mass (kg)

  4. Fat Free Mass Change

    Time frame: Baseline to 54 months

    Change in Fat Free Mass (kg)

  5. Fat Mass Maintenance

    Time frame: 18 months to 54 months

    Change in Fat Mass (kg)

  6. Fat Free Mass Maintenance

    Time frame: 18 months to 54 months

    Change in Fat Free Mass (kg)

Secondary outcomes

  1. Change in Physical Activity Patterns

    Time frame: 0, 6, 12, 18, 24, 54 month

    Physical activity patterns as measured by SenseWear armband (min/day)

  2. Physical Activity Patterns

    Time frame: 54 month

    Physical activity patterns as measured by ActivPAL, Actigraph (min/day)

  3. Change in Sleep

    Time frame: 0, 6, 12, 18, 24, 54 month

    Sleep patterns as measured by SenseWear armband (h/day)

  4. Sleep Patterns

    Time frame: 54 month

    Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)

  5. Change in Energy Intake

    Time frame: 0, 6, 12, 18, 54 month

    Energy Intake patterns as measured by 3 day food record (kcal/day

  6. Energy Intake Patterns

    Time frame: 54 month

    Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)

  7. Resting Metabolic Rate

    Time frame: 54 month

    Resting metabolic rate as measured using indirect calorimetry (kcal/day)

  8. Total Daily Energy Expenditure

    Time frame: 54 month

    Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)

  9. Physical Activity Energy Expenditure

    Time frame: 54 month

    Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2019
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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