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A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

在初级保健中预防体重增加的数字健康干预的务实试验

基本信息

批准号：
9273523
负责人：
Gary G Bennett
金额：
$ 69.19万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-15 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9273523
关键词：
Adoption Adult Affect Attenuated Body Weight Changes Body Weight decreased Caring Clinic Clinical Clinical Practice Guideline Community Health Centers Computer software Diastolic blood pressure Dietitian Effectiveness Evidence based treatment Feedback Glucose Goals Guidelines Health Internet Intervention Lipids Low income Medical Monitor North Carolina Obesity Outcome Outcome Measure Overweight Participant Patient-Focused Outcomes Patients Population Premenopause Preventive Intervention Primary Health Care Randomized Readiness Resources Risk Risk Marker Rural Rural Community Sampling Schedule Shapes Site Surgeon System Telephone Testing Text United States Agency for Healthcare Research and Quality Update Variant Vision Voice Vulnerable Populations Weight Weight Gain Woman Writing base behavior change cardiometabolic risk clinical practice cost digital effectiveness trial ethnic diversity ethnic minority population experience improved incremental cost-effectiveness innovation interest mHealth obesity risk obesity treatment patient population pragmatic trial prevent primary outcome programs public health relevance racial and ethnic response rural setting skills training success treatment as usual trial design weight gain prevention weight maintenance

项目摘要

DESCRIPTION (provided by applicant): Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical practice guidelines clearly recommend that these patients avoid gaining weight. Doing so might contain, or even attenuate, the adverse cardiometabolic risks that will likely accrue with additional weight gain. However, despite the clinical benefits, weight gain prevention interventions are not available in primary care practice. This evidence gap disproportionately affects medically vulnerable populations -- those who are low income, often racial/ethnic minority, and may reside in rural settings. These patients have the highest rates of obesity and weight gain but the least interest in, readiness for, and success with weight loss. The implications for these patients are clear: without intervention, most will continue to gain weight and incur cardiometabolic risks. Our Shape Program trial was the first to evaluate a weight gain prevention intervention in primary practice. Shape's participants were medically vulnerable, overweight and obese Black women who were not explicitly interested in weight loss. The 12-month Shape intervention consisted of tailored behavior change goals, weekly self-monitoring and tailored feedback via interactive voice response and monthly coaching calls from a clinic-based registered dietitian. After 18 months, intervention participants were twice as likel to have maintained their weight, compared to those receiving usual care. Recent analyses show that Shape's weight gain prevention effects have persisted for up to four years. To make Shape consistent with the latest obesity treatment guidelines, a key translational priority is to show tht Shape has generalized effects in a population of impoverished, rural, racially/ethnically diverse adults who are at high cardiometabolic risk. We propose to evaluate the effectiveness of an updated "Shape 2" weight gain prevention intervention in a pragmatic trial conducted in a rural community health center system. We will randomize 442 overweight and obese adults to either: 1) usual care, or 2) a 12-month weight gain prevention intervention consisting of self-monitoring and feedback via interactive voice response and/or text messaging, tailored skills training, and responsive coaching from a clinic dietitian. The primary outcome is the prevention of weight gain over 24 months post-baseline. We will also compare the updated Shape 2 intervention to usual care with respect to 24-month changes in cardiometabolic risk markers. Finally, we will evaluate Shape 2's dissemination potential and incremental cost-effectiveness.