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

Primary Purpose

Weight Loss, Weight Change, Body, Overweight or Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ready SET Health
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring emerging adults, women, weight loss barriers

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Weight change
Percent weight change (fasting weight in kg, measured in-person by trained assessors)

Secondary Outcome Measures

Weekly weight change
Weekly weight change (weight in lbs obtained through participants' Bluetooth-/wireless-connected study scale; converted to kg for analyses)

Full Information

First Posted
April 30, 2021
Last Updated
July 5, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04875091
Brief Title
Understanding Variability in Behavioral Weight Loss Treatment Response in Young Women (Ready SET Health)
Official Title
Understanding Drivers of Variability in Treatment Response Among Emerging Adults in Behavioral Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Change, Body, Overweight or Obesity
Keywords
emerging adults, women, weight loss barriers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Ready SET Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Description
Percent weight change (fasting weight in kg, measured in-person by trained assessors)
Time Frame
4-months (post-intervention)
Secondary Outcome Measure Information:
Title
Weekly weight change
Description
Weekly weight change (weight in lbs obtained through participants' Bluetooth-/wireless-connected study scale; converted to kg for analyses)
Time Frame
4-months (throughout intervention)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica G LaRose, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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