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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875091
• Other study ID #: HM20018520
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Obesity
• Overweight
• Overweight or Obesity
• Weight Change, Body
• Weight Loss

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Percent weight change (fasting weight in kg, measured in-person by trained assessors)	4-months (post-intervention)
Secondary	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)