Designing With Dissemination in Mind: Development of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy; Aim 1, Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS)
研究概览
简要总结
The objective of this study is to design and refine an activity support program for overweight or obese adults called Move. The primary outcomes are feasibility and acceptability of the Move physical activity support program.
详细描述
The purpose of this study is to design and refine a physical activity support program called Move, designed for adults with overweight or obesity. Participants will receive a 12-week, virtual physical activity support program called Move. Move includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) mental guided imagery sessions. Participants will be asked to build their physical activity levels up to 150 minutes/week. The primary outcome is to evaluate the program's acceptability and feasibility from both the participant and the provider perspectives.
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
- 是
入选标准
- •For both participant partners and the provider partner:
- •Have access to a computer and/or smart phone, and Wi-Fi
- •Speak English
- •For the participant partners only:
- •Body Mass Index 25-45 kg/m2
- •Insufficiently active (defined as <150 min/week of voluntary exercise at moderate intensity over the past 3 months)
- •Willing not to enroll in any other formal weight loss, physical activity program, or fitness center membership over the next 5 months.
- •Have a primary care physician (or has access to a healthcare professional and/or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
- •Capable and willing to give informed consent, understand exclusion criteria, attend the Move+ program sessions, and complete outcome measures.
- •For the provider partners only:
- •>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
排除标准
- •For participant partners:
- •Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription60 (i.e. have CVD symptoms or known CVD, diabetes, or end-stage renal disease).
- •Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 5 months will also be excluded
- •Self-reported cardiovascular disease:
- •Cardiac, peripheral vascular, or cerebrovascular disease
- •Self-reported symptoms suggestive of cardiovascular disease:
- •pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from cardiac ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication.
- •Self-reported end-stage renal disease
- •Self-reported diabetes (history of type 1 or type 2 diabetes)
- •Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate at the screening visit after 5 minutes of rest in a seated position.
- •Self-reported pulmonary disease requiring chronic oxygen supplementation; severe asthma or chronic obstructive pulmonary disease requiring hospitalization in past year.
- •Plans to relocate in the next 4 months
- •Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials.
- •Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
- •History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the exercise intervention.
- •History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
- •Current alcohol or substance abuse
- •Nicotine use (current or past 6 months)
- •Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants)
- •Regular use of obesity pharmacotherapeutic agents within the last 6 months.
- •Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening.
- •For provider partners:
结局指标
主要结局
Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS)
时间窗: 12 weeks
Acceptability of the Move physical activity support program will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. The score is calculated as a composite score from responders. Each responder rates the program between 0 and 10. Each responder is categorized as promotors (scores 9-10), passives (scores 7-8), or detractors (scores 0-6). The NPS is then calculated by the \[% of promoters (scores 9 or 10) minus % detractors (scores 6 or lower)\] multiplied by 100. Possible scores ranges from -100 to +100. Scores \>0 indicate the component is acceptable. Negative scores indicate that a higher percentage of respondents were classified as detractors (scores 6 or lower) compared to promoters (scores 9 or 10). Only one score is calculated per support program type. There is no measure of central tendency for this outcome. See https://www.netpromoter.com/know/ for more information in how this score is calculated.
Feasibility of the Move Physical Activity Support Program - Quantitative
时间窗: 12 weeks
Feasibility of the Move physical activity support program will be assessed using the Perceived Characteristics of Intervention Scale (PCIS) collected only at the level of the provider. Scores range from 0 to 4, with higher scores indicating a better outcome.
Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM)
时间窗: 12 weeks
Scores from the Feasibility of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability.
Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM)
时间窗: 12 weeks
Scores from the Acceptability of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability.
次要结局
未报告次要终点