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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04875091

Collaborator

(none)

Enrollment

Location

Arm

13.1

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Weight Change, Body Overweight or Obesity	Behavioral: Ready SET Health	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts 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