Clinical trial NCT04875091: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Change, Body
Overweight or Obesity
Keywords: emerging adults
women
weight loss barriers
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Weight change
timeFrame: 4-months (post-intervention)
Secondary outcomes:
measure: Weekly weight change
timeFrame: 4-months (throughout intervention)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jessica G LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References: