Understanding Drivers of Variability in Treatment Response Among Emerging Adults in Behavioral Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-25 years of age
- •BMI (body mass index) 25-45 kg/m2
- •Female gender identity
排除标准
- •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
研究组 & 干预措施
Intervention
干预措施: Ready SET Health (Behavioral)
结局指标
主要结局
Weight change
时间窗: 4-months (post-intervention)
Percent weight change (fasting weight in kg, measured in-person by trained assessors)
次要结局
- Weekly weight change(4-months (throughout intervention))