An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- body mass index as measured by height and weight
研究概览
简要总结
The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.
详细描述
The investigators have developed a new model for the treatment of obesity, which emphasizes the role of memory on food consumption in an overweight population.The pilot study will be an open label trial of a memory+behavioral weight loss (M+BWL) group treatment. The treatment will be administered in 14 group sessions over 16 weeks. The investigators will recruit adults with overweight and obesity and will assess them at baseline (prior to treatment), during treatment, post-treatment (immediately following treatment), and follow-up (3 months after treatment). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be overweight (BMI between 25-45)
- •Participant must be between the ages of 18-65
- •Participant can read at a minimum of an 5th grade level in English
- •Participant is willing to participate and to commit to 16 weeks of treatment and attendance at assessments
- •Participants must consent to audio-taping of assessment interviews and treatment group sessions.
- •Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.
排除标准
- •Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
- •Participants will not be moving out of the San Diego area for the duration of their study enrollment (7 months).
- •Participants will not be pregnant, planning to get pregnant during the 7-month study period or lactating.
- •Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
- •Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous, or would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status will not be included.
- •Participants cannot have a history of bariatric surgery
- •Participants cannot currently be enrolled in an organized weight control program.
研究组 & 干预措施
Memory + Behavioral Weight Loss (M+BWL)
The M+BWL program will integrate memory interventions to the BWL program. The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
干预措施: Memory + Behavioral Weight Loss (Behavioral)
结局指标
主要结局
body mass index as measured by height and weight
时间窗: Change from baseline at an average of 4 months and 7 months
kg/m\^2
次要结局
未报告次要终点
研究者
Kerri Boutelle
Prinicipal Investigator
University of California, San Diego