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

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Weight Loss

Overweight or Obesity

Weight Change, Body

Treatments

Behavioral: Ready SET Health

Study type

Interventional

Funder types

Other

Identifiers

NCT04875091

HM20018520

Details and patient eligibility

About

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).

Full 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).

Enrollment

48 patients

Sex

All

Ages

18 to 25 years old

Volunteers

No 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