Understanding Variability in Behavioral Weight Loss Treatment Response in Young Women (Ready SET Health)

Study Overview
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Brief Summary
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This study is a single-arm behavioral weight loss intervention for emerging adult women with in-person assessments at 0 (baseline) and 4 months (post-treatment) in addition to EMA data collection regarding risk factors known to interfere with program engagement and weight loss in this high-risk population (e.g., sleep, psychological distress, life events).

Detailed Description
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This study will implement a 4-month Internet-based behavioral weight loss intervention in order to collect ecological momentary assessment (EMA) data that will shed light on real-time barriers to weight management. The intervention is evidence-based and adapted with respect to content and delivery mode in order to meet the needs of emerging adult women. Consenting and eligible participants will receive 1 virtual group session led by a trained interventionist followed by weekly emails directing them to an intervention website housing video and .pdf content, weekly text messages, emailed tailored feedback regarding their weight loss behaviors and progress, and a closed Facebook group to facilitate social support. All participants will be followed for 4 months with hybrid in-person/virtual assessments at 0 and 4 months; in addition, all participants will be asked to respond to EMA prompts throughout the 4-month intervention period (Week 2, Week 4, Week 7, and Week 13).

Official Title
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Understanding Drivers of Variability in Treatment Response Among Emerging Adults in Behavioral Obesity Treatment

Conditions
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Weight Loss, Weight Change, Body, Overweight or Obesity

Intervention / Treatment
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* Behavioral: Ready SET Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-25 years of age BMI (body mass index) 25-45 kg/m2 Female gender identity Exclusion Criteria: Report of uncontrolled medical condition that may pose a safety issue given the recommendations for the diet and unsupervised physical activity Diagnosed cardiovascular or metabolic disease Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness Recent change in use of medications that may impact weight or metabolic function Cancer in the past 5 years, except non-melanoma skin cancers or early-stage cervical cancer Current symptoms of alcohol or other substance dependence Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months Hospitalization for depression or other psychiatric disorder within the past 12 months Lifetime history of bipolar disorder or psychotic disorder Planning to move from the area within the study period Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 6 months Current involvement in a weight loss program or current use of weight loss medication Recent significant weight loss Inability to read or speak English Lack of a smartphone or unwillingness to use it for study components

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Ready SET Health<br>* This behavioral weight loss intervention will span 16 weeks. The first session (Week 1) will be a virtual Weight Loss 101 group kick-off followed by 15 weeks of a technology-mediated program consisting of the following: weekly emailed content (videos and readings explaining key skills and strategies to produce weight loss) and weekly emailed tailored feedback (based on self-monitoring data from participants). A trained interventionist (coach) will lead the group session, provide weekly tailored feedback, and monitor participant progress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Percent weight change (fasting weight in kg, measured in-person by trained assessors) | 4-months (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly weight change | Weekly weight change (weight in lbs obtained through participants' Bluetooth-/wireless-connected study scale; converted to kg for analyses) | 4-months (throughout intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emerging adults, women, weight loss barriers