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临床试验/NCT03160755
NCT03160755已完成不适用

Developing a Group-based Positive Psychology and Physical Activity Intervention in Patients With Metabolic Syndrome: Qualitative Research Phase

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Qualitative Data

研究概览

简要总结

Specific Aim #1: To identify, through qualitative research, deficits in positive emotional states (e.g., positive affect, optimism) and associated barriers to completing health behaviors, like physical activity and healthy eating, in patients with metabolic syndrome (MetS).

Hypothesis: Participants will be able to complete semi-structured interviews, providing information about their positive emotional states, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, motivational) to completing such behaviors.

详细描述

This qualitative interview study will focus on the development of a novel positive psychology (PP) and motivational interviewing (MI) intervention that is adapted for patients with MetS. For this phase, participants will be primary care patients recruited through Massachusetts General Hospital's research opt-in program (Research Options Direct to You [RODY]). We will complete phone interviews with patients (n=20) with MetS within two weeks of enrollment in the study.

In this project, we hope to do the following:

  1. Identify, through qualitative research, deficits in positive emotional states in primary care patients with MetS.
  2. Examine potential links between positive emotional deficits and impaired health behaviors (low physical activity, unhealthy dietary patterns), as well as links between positive emotional states and successful health behaviors.
  3. Identify other barriers to health behavior completion, such as social support and neighborhood resources.
  4. Explore strategies to enhance positive emotional states in MetS patients and inquire about the utility of potential PP exercises in these patients.
  5. Ask participants for feedback about intervention delivery preferences (e.g., session length, time of day, duration of intervention).
  6. Develop a preliminary PP-MI based group intervention using the above information.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both of the two MetS components most strongly related to MetS outcomes and most sensitive to lifestyle change:
  • elevated abdominal obesity (waist circumference >102 cm in men or >88 cm in women)
  • If waist circumference is not available, body mass index (BMI) will be used as a surrogate measure based on prior research (BMI ≥29.1 kg/m2 for men and 27.2 kg/m2 for women).
  • elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg or be on blood pressure medication).
  • Plus ≥1 additional MetS component:
  • Serum triglycerides ≥150 mg/dL
  • High-density lipoprotein (HDL) cholesterol <40 mg/dL in men or <50 mg/dL in women
  • Fasting plasma glucose >100mg/dL.
  • Suboptimal physical activity defined as <150 minutes/week moderate intensity activity, which represents less than national-level recommendations.

排除标准

  • Inability to speak/read English
  • Cognitive deficits impeding ability to participate or provide informed consent (measured by a 6-item screen)
  • Illness likely to lead to death in the next 6 months per PCP
  • Current treatment for cancer, liver, or renal disease
  • Pregnancy
  • Documented severe mental illness (e.g., psychosis, suicidality)
  • No telephone access
  • Inability to be physically active
  • Diabetes or known or suggested cardiac disease, given that this is a primary prevention study.

结局指标

主要结局

Qualitative Data

时间窗: Baseline

Themes related to: health behaviors, barriers to completing health behaviors, positive emotional/cognitive experiences and how these may impact adherence to the MetS health behaviors of interest (primarily physical activity).

次要结局

  • Dispositional Optimism(Baseline)
  • Barriers to Physical Activity(Baseline)
  • Positive Affect(Baseline)
  • Depression(Baseline)
  • Environmental Barriers and Resources(Baseline)
  • Health Related Quality of Life(Baseline)
  • Anxiety(Baseline)
  • Physical Activity(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Millstein

Assistant in Psychology

Massachusetts General Hospital

研究点 (1)

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