Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Conditions
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Obesity, Weight Change, Body

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants from NCT01985568 or NCT03411356<br>All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356). | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, sleep, eating patterns, energy expenditure