Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Change in total volume of structured PA
研究概览
简要总结
We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 50-64
- •BMI 25-40
- •Sedentary or low-active, defined as participating in < 60 min/week of structured exercise
- •Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app
排除标准
- •Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):
- •Past 3-month overnight hospitalization
- •Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm
- •Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
- •Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
- •Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
- •Past 6-month seizure
- •Past 6-month overnight hospitalization due to respiratory disease
- •Past 6-month lightheadedness, vertigo, dizziness, or fainting
- •Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
- •Takes insulin and/or medication that affects the secretion of insulin
- •Exercise-induced asthma that prevents brisk walking
- •Takes anticonvulsant medication or medication to treat/control seizures
- •Diagnosed with cystic fibrosis
- •Bone or joint problems that make you unable to walk for at least 30 minutes
- •Physician has said not to exercise because of bone or joint problems
- •Physician has said a hip or knee replacement will be needed in the next 12 months
- •Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes
- •Currently taking or planning on taking medications that affect HR, such as beta or calcium channel blockers or digoxin, as HR will be used to determine the moderate intensity range for participants assigned to that condition
- •Past 12-month overnight psychiatric hospitalization
- •Currently pregnant or planning to become pregnant in the next year
- •Currently participating in any exercise or weight-loss research studies
- •Household member is participating in this study
- •Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
- •Unable to receive materials in the mail at residential mailing address
- •Does not plan to live in Rhode Island for the next 12 months
- •Unable to speak, read, and/or write fluently in English
- •Smokers will be eligible, but smoking status will be included as a covariate in analyses
研究组 & 干预措施
Self-Paced Intensity Physical Activity
干预措施: Self-Paced Intensity Physical Activity (Behavioral)
Prescribed Moderate Intensity Physical Activity
干预措施: Prescribed Moderate Intensity Physical Activity (Behavioral)
结局指标
主要结局
Change in total volume of structured PA
时间窗: Measured at baseline, and months 3, 6, 9, and 12.
Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Minutes per week of PA
时间窗: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
次要结局
- Changes in Body Weight(Measured at baseline, and months 3, 6, 9, and 12.)
研究者
David M. Williams
Professor
Brown University