Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants Completing Objective Physical Activity Measurement
研究概览
简要总结
Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the positive psychology (PP)-motivational interviewing (MI) group-based physical activity intervention and outcome assessments in patients with metabolic syndrome (MetS).
Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/8 exercises/sessions. Furthermore, we will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at 8 weeks.
Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP and MI exercise.
Hypothesis: The intervention will be acceptable: participants will rate each PP and MI exercise with a mean score of at least 7 out of 10 on ratings of ease of completion and helpfulness.
Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), and psychological well-being (optimism, positive affect, anxiety, depression).
Hypothesis: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, and reductions in depression and anxiety at 8 weeks compared to baseline.
详细描述
In this proof-of-concept study, investigators will run two 8-week PP-MI groups (complete n=8 each, n=16 total) for primary care patients with MetS. Investigators will use ratings of feasibility and acceptability for each of the sessions and obtain objective physical activity measures pre- and post- group. Investigators will also obtain questionnaire-based information related to health behavior adherence and psychological and physical health to ensure the feasibility of these methods prior to further testing. Investigators may gather exit interview data to assess participant liking, utility, and additional needs, to allow for further refinement of the intervention.
Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of the population. This information will include medical data related to MetS (e.g., blood sugar, blood pressure, body mass index, triglycerides, cholesterol), current medications, and sociodemographic data (age, gender, race/ethnicity, education, marital status).
Participants will attend 90-minute groups sessions that will be held at two primary care clinics (MGH Healthcare Centers). The overall structure of each session will be: 30 minutes for positive psychology exercise review/discussion, 30 minutes for physical activity goal setting, education, and discussion, and 30 minutes for a group walk or indoor exercises in inclement weather.
Participants will be asked to wear an Actigraph GT3x+ accelerometer for 1 week at baseline and 1 week at follow-up to assess the feasibility of doing so. Accelerometers such as this one are considered to be the standard for measuring habitual physical activity. They are pedometer-size devices that attach to a belt and are worn at the waist. Participants will also be given a Fitbit Zip to keep, which they will be asked to wear daily for the duration of the study in order to track their activity (steps).
Upon beginning the groups, participants will be provided with a treatment manual with weekly PP exercises, information about the importance of physical activity and related health behaviors, and how to set goals to improve these behaviors. The PI will lead all groups.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Number of Participants Completing Objective Physical Activity Measurement
时间窗: 8 weeks of group sessions
Feasibility will be measured by examining the number of participants who wore Actigraphs with sufficient wear time both at baseline and at follow-up
Number of PP-MI-Based Health Behavior Intervention Exercises Completed
时间窗: 8 weeks of group sessions
Feasibility will be measured by examining the number of completed exercises.
次要结局
- Acceptability of Intervention(8 weeks)
- Change in SF-12 Scores - Mental Composite Score(Change in score from Baseline to 8 weeks)
- Changes in The Medical Outcomes Study Short Form-12 Scores - Physical Composite Score(Change in score from Baseline to 8 weeks)
- Change in HADS-D Scores(Change in score from Baseline to 8 weeks)
- Change in BRFSS- Vegetable Module(Change in # of vegetables consumed/day from Baseline to 8 weeks)
- Physical Activity Adherence (Actigraph)(Change in physical activity level from baseline to 8 weeks)
- Changes in Positive and Negative Affect Schedule Scores(Change in score from Baseline to 8 weeks)
- Changes in The Neighborhood Environment Walkability Scale-Abbreviated Scores(Change in score from Baseline to 8 weeks)
- Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module - Fruit Category(Change in # of fruits consumed/day from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score- Lack of Willpower(Change in score from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score - Lack of Skill(Change in score from Baseline to 8 weeks)
- Changes in Life Orientation Test- Revised Scores(Change in dispositional optimism from baseline to 8 weeks)
- Changes in The HADS-A Scores(Change in score from Baseline to 8 weeks)
- Changes in Barriers to Being Active Quiz- Lack of Time Scores(Baseline and 8 weeks)
- Changes in The Community Healthy Activities Model Program for Seniors Scores(Change in score from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score - Lack of Resources(Change in score from Baseline to 8 weeks)
- Changes in National Cancer Institute's Percentage Energy From Fat Screener Scores(Change in number of times fat is consumed per day from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score- Lack of Energy(Change in score from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score- Social Influence(Change in score from Baseline to 8 weeks)
- Change in Barriers to Being Active Quiz Score - Fear of Injury(Change in score from Baseline to 8 weeks)
研究者
Rachel Millstein
Assistant in Psychology
Massachusetts General Hospital