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

Not Applicable

Completed

• Conditions: Weight Change, Body; Overweight or Obesity; Weight Loss
• Interventions: Behavioral: Ready SET Health

• Registration Number: NCT04875091
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-06
• Study Start: 2021-07-28
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Ready SET Health	-

Primary Outcome Measures

Name	Time	Method
Weight change	4-months (post-intervention)	Percent weight change (fasting weight in kg, measured in-person by trained assessors)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States