Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults with Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
优化对患有多种慢性病的老年人进行远程医疗的减肥干预:一项序贯、多项分配、随机试验
基本信息
- 批准号:10583917
- 负责人:
- 金额:$ 77.39万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-02-15 至 2028-01-31
- 项目状态:未结题
- 来源:
- 关键词:AddressAnthropometryArthritisBehavior TherapyBehavioralBody Weight ChangesBody Weight decreasedCessation of lifeCharacteristicsChronicClinicalClinical TrialsCollaborationsCombined Modality TherapyComplexCost AnalysisDataDiabetes MellitusDietitianElderlyEnrollmentEvaluationEvidence based interventionFutureGeriatricsGoalsHealthHealth Care CostsHealth PromotionHealth behavior changeHypertensionIndividualInstitute of Medicine (U.S.)InterventionLicensingLife StyleMedicalMedicareModelingMotivationNational Institute on AgingNursing HomesNutritional StudyObesityOutcomeParticipantPatientsPatternPersonsPhysical FunctionPilot ProjectsPoliciesPositioning AttributePrecision HealthPrevalenceProblem SolvingQuality of lifeQuality-Adjusted Life YearsRandomizedResearchResearch PriorityRiskRisk FactorsScienceSequential Multiple Assignment Randomized TrialStrategic PlanningTelemedicineTestingTimeTrainingUnited States National Institutes of HealthWeightWeight GainWorkadaptive interventionadult obesityadverse outcomearmclinical decision-makingclinical heterogeneityclinically significantcomparative effectiveness trialcost effective interventioncost effectivenessdiet and exercisedisabilitydisability riskefficacy evaluationexercise prescriptionfunctional declineglobal healthhealth traininghigh riskhigh risk populationimprovedincremental costindexingindividualized medicineinnovationmortalitymultiple chronic conditionsmuscle formpersonalized approachpersonalized carephysical therapistpilot testpost interventionprecision medicineprimary care providerprimary outcomerandomized trialremote monitoringresponsesecondary outcomeskillssuccesstelehealthtreatment responsetreatment strategytrial designweight loss intervention
项目摘要
PROJECT SUMMARY
Consistent with the research priorities of the National Institute on Aging, this R01 application will investigate the
optimal intervention sequence to achieve weight loss in older adults with obesity and ≥ 2 Medicare-defined
multiple chronic conditions (MCC). The growing prevalence of obesity in older adults, particularly in those with
common chronic conditions such as diabetes, hypertension, or arthritis, increases the risk of functional decline,
nursing home placement, and early mortality. Weight loss interventions can mitigate such adverse outcomes;
however, differential response to treatment is often observed due to a patient’s clinical heterogeneity. Clinicians
lack guidance on the most effective lifestyle-based intervention, and which intervention to try if the first one fails.
An innovative Sequential, Multiple Assignment, Randomized Trial (SMART) design will be conducted to identify
optimal intervention approaches for weight loss in older adults with MCC, tailoring strategies for non-responders
to weight loss. During the 52-week, two-stage trial, 180 older adults with obesity and MCC will be enrolled to
compare two weight loss interventions: a prescriptively focused, medically tailored, weight loss intervention
(prescriptive), and a behaviorally focused, health coaching intervention (behavioral). Consistent with a SMART
design, at 8-weeks, early non-responders (weight loss of <2.5%) will be randomized to: (a) more sessions of the
original assignment; (b) a combination of prescriptive and behavioral interventions; or (c) a switch to a
prescriptive, medically tailored strategy (initial, first-line behavioral arm participants) or to a behaviorally focused
health coach-delivered strategy (initial prescriptive arm participants). The SMART will enable the identification
of the treatment combinations that maximize weight loss at 52-weeks. To this end, the proposal aims to: 1) test
the superiority of an initial (first-line) 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; and 3)
examine the cost-effectiveness from a societal perspective for maintaining weight loss of the proposed treatment
sequences at 78-weeks (26-weeks post-intervention completion). The primary outcome is percent weight loss at
52-weeks; secondary outcomes include global health and physical function, anthropometry, behavioral treatment
targets and risk factors, and clinical indices. Based on preliminary data, it is hypothesized that older adults with
obesity and MCC will achieve greater weight loss with a prescriptive, medically tailored intervention, and the
estimated adaptive intervention strategy tailored to a patient’s characteristics will lead to better outcomes than a
fixed intervention. If the trial is successful, the adaptive strategy will be compared to a fixed prescriptive or
behavioral strategy in a future comparative effectiveness trial. The proposed approach should benefit patients
facing competing and complex medical issues who are underrepresented in clinical trials. This study aligns with
the NIH Strategic Plans for Obesity, Nutrition Research, and Precision Health, and is responsive to the Institute
of Medicine’s call for telehealth research that may influence policy by advancing health delivery science.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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John A. Batsis其他文献
Central venous catheter thrombosis complicated by paradoxical embolism in a patient with diabetic ketoacidosis and respiratory failure
- DOI:
10.1385/ncc:2:2:185 - 发表时间:
2005-01-01 - 期刊:
- 影响因子:3.600
- 作者:
John A. Batsis;Iasmina M. Craici;David A. Froehling - 通讯作者:
David A. Froehling
Sarcopenic Obesity and Cardiovascular Disease: An Overlooked but High-Risk Syndrome
- DOI:
10.1007/s13679-024-00571-2 - 发表时间:
2024-05-16 - 期刊:
- 影响因子:11.000
- 作者:
Saeid Mirzai;Salvatore Carbone;John A. Batsis;Stephen B. Kritchevsky;Dalane W. Kitzman;Michael D. Shapiro - 通讯作者:
Michael D. Shapiro
Changes in Weight or Body Composition by Frailty Status: A Pilot Study.
虚弱状态导致的体重或身体成分变化:一项试点研究。
- DOI:
10.1080/21551197.2024.2326807 - 发表时间:
2024 - 期刊:
- 影响因子:0
- 作者:
Hillary B Spangler;D. Lynch;Danae C Gross;S. Cook;John A. Batsis - 通讯作者:
John A. Batsis
Sarcopenic obesity in older adults: a clinical overview
老年人肌少症性肥胖:临床综述
- DOI:
10.1038/s41574-023-00943-z - 发表时间:
2024-02-06 - 期刊:
- 影响因子:40.000
- 作者:
Carla M. Prado;John A. Batsis;Lorenzo M. Donini;M. Cristina Gonzalez;Mario Siervo - 通讯作者:
Mario Siervo
Normal Weight-Central Obesity Is Associated with the Highest Mortality Risk in Older Adults with Coronary Artery Disease*<sup>†</sup>
- DOI:
10.1016/j.jacl.2015.03.103 - 发表时间:
2015-05-01 - 期刊:
- 影响因子:
- 作者:
Saurabh Sharma;John A. Batsis;Thais Coutinho;Virend K. Somers;Charlotte Kragelund;Alka M. Kanaya;Francisco Lopez-Jimenez - 通讯作者:
Francisco Lopez-Jimenez
John A. Batsis的其他文献
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{{ truncateString('John A. Batsis', 18)}}的其他基金
Interdisciplinary Nutrition Sciences Symposium: Obesity and the Brain Across the Life Course
跨学科营养科学研讨会:整个生命过程中的肥胖与大脑
- 批准号:
10753871 - 财政年份:2023
- 资助金额:
$ 77.39万 - 项目类别:
COVID Extension: Mobile Health Obesity Wellness Intervention in Rural Adults
COVID 扩展:农村成人的移动健康肥胖健康干预
- 批准号:
10579010 - 财政年份:2022
- 资助金额:
$ 77.39万 - 项目类别:
Mobile Health Obesity Wellness Intervention in Rural Older Adults_Res1
农村老年人移动健康肥胖健康干预_Res1
- 批准号:
9927962 - 财政年份:2016
- 资助金额:
$ 77.39万 - 项目类别:
Mobile Health Obesity Wellness Intervention in Rural Older Adults_Res1
农村老年人移动健康肥胖健康干预_Res1
- 批准号:
9324117 - 财政年份:2016
- 资助金额:
$ 77.39万 - 项目类别:
Mobile Health Obesity Wellness Intervention in Rural Older Adults_Res1
农村老年人移动健康肥胖健康干预_Res1
- 批准号:
9485197 - 财政年份:2016
- 资助金额:
$ 77.39万 - 项目类别:
Mobile Health Obesity Wellness Intervention in Rural Adults
农村成年人的移动健康肥胖健康干预
- 批准号:
10250588 - 财政年份:2016
- 资助金额:
$ 77.39万 - 项目类别:
Mobile Health Obesity Wellness Intervention in Rural Older Adults_Res1
农村老年人移动健康肥胖健康干预_Res1
- 批准号:
9431763 - 财政年份:2016
- 资助金额:
$ 77.39万 - 项目类别:
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