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

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

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).

Study Overview

• Status: Completed
• Conditions: Weight Loss; Overweight or Obesity; Weight Change, Body
• Intervention / Treatment: Behavioral: Ready SET Health

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

Behavioral: Ready SET Health; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jessica G LaRose, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: women; emerging adults; weight loss barriers
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Weight Loss; Overweight; Body Weight; Body Weight Changes
• Other Study ID Numbers: HM20018520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No