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临床试验/NCT03500640
NCT03500640已完成不适用

Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2018年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
314
试验地点
2
主要终点
Change in Bodyweight

研究概览

简要总结

Obesity and pre-diabetes threatens the overall health and functional independence of older adults but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare, can reduce this burden. The current 24-month study will enroll adults, ages 60 and older, through senior community centers and research registries. The investigators will study how two long term weight loss maintenance programs, both using group telephone sessions to support health behavior change, impact meaningful health outcomes. If successful, this project will provide a sustainable intervention model for healthy aging services that can benefit older adults and society.

详细描述

The confluence of obesity and pre-diabetes in older adults increases the risk of diabetes, and accelerates functional decline, chronic disease, disability, and death. More research is needed to refine and extend preventive interventions to reduce burden for vulnerable individuals and society. For over a decade efficacious 6- and 12-month Diabetes Prevention Program (DPP) lifestyle interventions have been translated successfully and shown positive impact. However, efforts to develop and evaluate scalable programs conforming to current guidelines for longer term DPP interventions (up to 24 months), which are consistent with a chronic care model, and help a greater proportion of enrollees sustain the recommended weight loss target of ≥ 5% are lacking. The scientific premise is that evaluation of translational DPP interventions, which has centered largely on strategies for weight loss induction, must be extended to include scalable longer-term interventions that show meaningful weight, cardiometabolic and functional health benefits for vulnerable older adults in community-based settings. A previous DPP-based study from this group of investigators documented the utility of telephone follow-up after 12-weeks of DPP weight loss induction and demonstrated that 63% of the 65-80-year-old volunteer sample with obesity and other risk factors were able to sustain ≥ 5% weight loss at 12-months. Despite good evidence that longer duration lifestyle interventions yield better outcomes (reflected in the latest Medicare ruling) there are no translational studies of 24-month long DPP-based interventions for older adults exclusively. The investigators will recruit participants from a broad array of community settings and examine how best to sustain the impact of a healthy lifestyle-healthy aging focused DPP with scalable treatment components over a 24-month period. The Sustain-DPP study will recruit and enroll adults 60 years of age and older, with overweight/obesity (BMI >= 27) and pre-diabetes (either HbA1c of 5.7 to 6.4% inclusive or fasting glucose >=100 but less than 126 mg/dL) (N = 360) from a network of community centers that offer healthy aging services and from community research registries. The intervention program sequence has been designed to align with current Medicare guidelines. First, from 0-6 months, experienced lifestyle coaches will administer a combination of in-person, video and telephone coaching sessions for all participants, at least 25% from ethnic/racial minority groups. Next, individual participants will be randomized (N = 180 per arm; stratified by weight loss of < or ≥ 5% and other demographic factors) to one of two 18-month follow-up conditions delivered as once-a-month telephone sessions only from 6-24 months. The investigators will compare the effects of (1) 30-minute behavioral intervention sessions, which include a Medicare-DPP and healthy lifestyle for healthy aging focus, and (2) 15-minute social support sessions, on measures of weight (the primary outcome) at 12-, 18-, and 24-months. In addition, data will be collected on cardiometabolic, physical activity, physical function, psychosocial, behavioral and other age-sensitive quality of life measures at 12- and 18- and 24-months. Finally, Medicare claims data will be examined for a proportion of the sample regarding medication use, outpatient, inpatient, and emergency visits and enrollment/participation in elder-focused activity programs. This work, if successful, will have immediate potential for DPP-sustainable lifestyle interventions that benefit vulnerable aging individuals and society.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • Ages 60 and older
  • Body mass index (BMI) >= 27 kg/m2
  • Prediabetes defined as Hemoglobin (HbA1c) >= 5.7 % and <= 6.4 % or fasting glucose of >= 100 mg/dL and less than 126 mg/dL (at either screening or baseline visit)
  • Access to a telephone (for group calls) and to video-player or computer with Internet (to watch session videos and activity videos)
  • Able to travel to one of the community clinics in Southwestern Pennsylvania to participate in the first four in-person intervention sessions and five health assessments at 0, 6, 12, 18, and 24 months
  • Has health care provider permission to participate

排除标准

  • Currently diagnosed with diabetes (defined as HbA1c of >= 6.5% at either screening or baseline visit)
  • Currently taking glucose lowering medications or weight loss medications
  • Weight loss of 9 pounds or more in the last six months
  • History of bariatric surgery within the last 2 years
  • Permanently confined to wheelchair
  • Significant cognitive or psychiatric disability that would preclude participation in normal community-based educational activities

结局指标

主要结局

Change in Bodyweight

时间窗: 24-month change from baseline bodyweight

Percent bodyweight change (clinic measured) of participant.

次要结局

  • Change in High-density Lipoprotein (HDL)(24-month change from baseline fasting HDL)
  • Change in Triglycerides(24-month change from baseline fasting triglycerides at 24 months)
  • Change in Fasting Insulin(24-month change from baseline fasting insulin)
  • Change in Physical Function(24-month change from baseline total score)
  • Change in Hemoglobin (HbA1c)(24-month change from baseline fasting HbA1c)
  • Change in Total Cholesterol(24-month change from baseline fasting total cholesterol)
  • Change in Low-density Lipoprotein (LDL)(24-month change from baseline fasting LDL)
  • Change in Systolic Blood Pressure (SBP)(24-month change from baseline SBP)
  • Change in Waist Circumference(24-month change from baseline waist circumference)
  • Change in Fasting Glucose(24-month change from baseline fasting glucose)
  • Change in Diastolic Blood Pressure (DBP)(24-month change from baseline DBP.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Venditti

Associate Professor of Psychiatry and Epidemiology

University of Pittsburgh

研究点 (2)

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