Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in weight from baseline
研究概览
简要总结
This study seeks to answer the fundamental questions of which initial, first-line weight loss intervention should be offered to older adults with obesity and multiple chronic conditions and how to address the high non-response rates observed with most conventional strategies. A sequential, multiple assignment, randomized trial (SMART) design will permit the evaluation of treatment combinations that maximize weight loss and will provide data on constructing a future tailored, adaptive intervention. If successful, these findings will identify interventions that could markedly improve health and quality of life of these older adults, reduce long-term disability, and lower healthcare costs
详细描述
Purpose: Consistent with the research priorities of the National Institute on Aging, this research protocol will investigate the optimal intervention sequence to achieve weight loss in older adults with obesity and more than 2 chronic conditions, termed multiple chronic conditions (MCC). To this end, the specific aims are to: 1) test the superiority of an initial prescriptive or behavioral intervention using an adaptive strategy for early non-responders; 2) assess the patterns of initial weight loss and compare strategies for non-responders using an adaptive strategy; and 3) examine the cost-effectiveness from a societal perspective for maintaining weight loss of the proposed sequences at 52 weeks.
Procedures (methods): The investigators will conduct a 52-week, two-stage, Sequential, Multiple Assignment, Randomized Trial (SMART) enrolling 180 older adults with obesity and MCC to compare two weight loss interventions: 1) a prescriptively-focused, medically-tailored, weight loss intervention (prescriptive), or 2) a behaviorally-focused, health coaching intervention (behavioral). Consistent with a SMART design, at 8 weeks, the investigators will randomize early non-responders (weight loss of < 2.5%) to (a) a combination of prescriptive and behavioral interventions; or (b) switching to either a prescriptive, medically-tailored model (or vice versa).
Aim 1 - Efficacy Test the superiority of an initial prescriptive vs. behavioral intervention on the differences in weight loss (primary outcome) and secondary outcomes, using an adaptive strategy for early non-responders in a 52-week, telehealth-based SMART. At 52-weeks, percent weight loss (primary outcome) will be greater among patients initially randomized to a prescriptive intervention, as will global health and physical function, anthropometry, behavioral treatment targets and risk factors, and clinical indices (secondary outcomes).
Aim 2 - Precision Medicine Assess the patterns of initial weight loss and compare strategies for non-responders to weight loss (combined prescriptive and behavioral, or switching initial treatment strategies [prescriptive to behavioral, or behavioral to prescriptive]). The investigators will estimate an adaptive strategy (dynamic treatment regime) to give the right intervention to the right participant. The investigators hypothesize that this dynamic regime will lead to a better outcome, on average, compared to the best non-adaptive (fixed) regime
Aim 3 - Cost-Effectiveness Examine the cost-effectiveness from a societal perspective at 52-weeks. For the initial, first-line interventions, the investigators will estimate the incremental cost per percent weight change and assess secondary outcomes of the incremental cost for maintaining at least a 5% weight loss, and quality-adjusted life years. The investigators will also model the cost-effectiveness of the precision medicine approach predicted to have the greatest individualized likelihood of weight loss response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
This trial will have a single-masked design, so the team assessing study outcomes is masked to intervention assignment. Participants will be asked not to reveal their assignment. Arm assignment cannot be blinded due to the study's design. The assessment team will schedule assessments to minimize contact with the intervention team to maintain separation. Data entry and analysis will be blinded to the study investigators, besides Kosorok and team. Assessments will be done at different times and in separate areas at the study site. The intervention setting for participants will be in their homes. To enhance continued masking, participants will be asked not to disclose their assigned group and not to discuss their intervention arms during assessment sessions. Assessment of compliance to the intervention will be performed by the intervention team and not by the outcome assessment team. The investigators will be blinded to data analysis, collection, and study arms.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria based on chart review at the time of screening (within 8 weeks of randomization):
- •Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);
- •Aged 65-85 years (unclear benefits of weight loss if >85 years)
- •Obesity (body mass index: ≥30 kg/m2);
- •English-speaking;
- •≥2 chronic medical conditions that require ongoing care (excluding dementia and osteoporosis as a chronic condition) - these are based on Medicare' MCC (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, Human Immunodeficiency Virus / Acquired Immunodeficiency Disease Syndrome, hyperlipidemia, hypertension, ischemic heart disease, schizophrenia/other psychotic disorders, stroke). We acknowledge that there are no fully defined definitions and hence we will be assessing MCC (or multimorbidity) in different manners;
- •medical clearance by PCP (Primary Care Provider)
- •Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent);
- •OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability)
- •Readiness to change score of ≥6/10;
排除标准
- •Any individual who meets one or more of the following criteria will be excluded from participation based on chart review at the time of screening (within 8 weeks of randomization):
- •documented diagnosis in the electronic health record of dementia of any type;
- •documented diagnosis in the electronic health record of weight loss surgery in the past;
- •untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review;
- •life-threatening illness;
- •terminal illness (e.g., palliative care, hospice patient) based on medical record review whose life expectancy is <12 months as determined by a physician;
- •nursing home or hospital admission in past three months;
- •advanced comorbidities based on medical record review;
- •heart - recent hospital admission for heart failure, myocardial infarction, stroke in past 3 months, unstable disease (new york class III or IV congestive heart failure);
- •chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR [glomerular filtration rate] <30ml/min);
- •non-skin cancer - history of requiring active treatment in the past year;
- •liver failure or cirrhosis;
- •chronic obstructive pulmonary disease - on oxygen or requiring steroids;
- •weight loss contraindication as noted by the PCP;
- •instability of weight loss, which is greater than 5% weight loss in the past 12 weeks;
- •anti-obesity medications including orlistat, semaglutide, liraglutide, tirzepetide, naltrexone-bupropion and phentermine prior to initiation of study procedures;
- •current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, Parathyroid Hormone Analogues (PTH-analogues [e.g., teriparatide, abaloparatide], sclerostin) inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years;
- •osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures;
- •elective surgery in next 12 months;
- •recent (<1 mo) COVID-19 infection;
- •current or past participation (in the past 12 months) in another weight-loss study;
- •Planning on moving out of the area in the next 18 months.
研究组 & 干预措施
Prescriptive
A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals- Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapy: 40 min).
干预措施: Prescriptive (Other)
Behavioral
Health coaches have a bachelor's degree and take a 6-8-week certification program. Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine.
Conceptual model targets include:
- barrier identification: problem-solving to identify and address barriers to meet goals
- self-regulation: a focus on self-monitoring and behavior goals with feedback
- autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.
干预措施: Behavioral (Behavioral)
Responders to Prescriptive- Continue Prescriptive
The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.
干预措施: Prescriptive (Other)
Non-responders to Prescriptive- Switch to Behavioral
Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.
干预措施: Behavioral (Behavioral)
Non-responders to Prescriptive- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
干预措施: Prescriptive (Other)
Non-responders to Prescriptive- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
干预措施: Behavioral (Behavioral)
Responders to Behavioral- Continue Behavioral
The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.
干预措施: Behavioral (Behavioral)
Non-responders to Behavioral- Switch to Prescriptive
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants switch first-line treatment strategy to the alternative (prescriptive) as participants may need knowledge to support adherence.
干预措施: Prescriptive (Other)
Non-responders to Behavioral- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
干预措施: Prescriptive (Other)
Non-responders to Behavioral- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
干预措施: Behavioral (Behavioral)
结局指标
主要结局
Change in weight from baseline
时间窗: 8, 26, 52 weeks
Absolute change in weight percentage (%) over time from baseline to 52-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.
次要结局
- Change in appendicular lean mass from baseline(0, 26, 52 weeks)
- Change in volume of visceral fat from baseline(0, 26, 52 weeks)
- Change in % body fat from baseline(0, 26, 52 weeks)
- Telehealth usability survey(52 weeks)
- Change in Patient reported outcomes measurement information systems (PROMIS)- Global health(0, 8, 16, 26, 52 weeks)
- Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function(0, 8, 16, 26, 52 weeks)
- Change in 30-second sit-to-stand from baseline(0, 8, 26, 52 weeks)
- Change in grip strength from baseline(0, 8, 26, 52 weeks)
- Change in gait speed from baseline(0, 8, 26, 52 weeks)
- Change in 6-minute walk from baseline(0, 8, 26, 52 weeks)
- Change in waist circumference from baseline(0, 8, 26, 52 weeks)
- Change in hip circumference from baseline(0, 8, 26, 52 weeks)
- Proportion with greater than or equal to 5% weight loss(8, 26, 52 weeks)
- Late-life function and disability instrument(0, 8, 16, 26, 52)
- Change in Pittsburgh Fatigability questionnaire(0, 8, 16, 26, 52 weeks)
- Change in Self-efficacy- exercise(0, 8, 16, 26, 52 weeks)
- Change in Self-efficacy- nutrition(0, 8, 16, 26, 52 weeks)
- Change in Self-efficacy- technology(0, 8, 16, 26, 52 weeks)
- Change in Goal setting- exercise(0, 8, 16, 26, 52 weeks)
- Change in Goal setting- nutrition(0, 8, 16, 26, 52 weeks)
- Change in Goal setting- technology(0, 8, 16, 26, 52 weeks)
- Change in social support for diet(0, 8, 16, 26, 52 weeks)
- Change in social support for exercise(0, 8, 16, 26, 52 weeks)
- Treatment self-regulation: diet(0, 8, 16, 26, 52 weeks)
- Treatment self-regulation: exercise(0, 8, 16, 26, 52 weeks)
- Change in caloric intake(0, 8, 16, 26, 52 weeks)
- Physical activity: community healthy activities model program for seniors(0, 8, 16, 26, 52 weeks)
- Patient activation measure(0, 8, 16, 26, 52 weeks)
- Fitbit use- Wear/non-wear time(0, 8, 16, 26, 52 weeks)
- Fitbit use- activity/steps(0, 8, 16, 26, 52 weeks)
- Attendance(52 weeks)
- Acceptability of Study Intervention(52 weeks)
- Percent of participants rating the intervention as acceptable(52 weeks)
- Telehealth satisfaction(52 weeks)
- Change in systolic blood pressure(0, 8, 26, 52 weeks)
- Change in diastolic blood pressure(0, 8, 26, 52 weeks)
- Change in low density lipoprotein blood levels(0, 52 weeks)
- Change in high density lipoprotein blood levels(0, 52 weeks)
- Change in total cholesterol blood levels(0, 52 weeks)
- Change in glucose blood levels(0, 52 weeks)
- Change in calf circumference from baseline(0, 8, 26, 52 weeks)
- Change in arm circumference from baseline(0, 8, 26, 52 weeks)