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临床试验/NCT02561221
NCT02561221已完成不适用

Promoting Successful Weight Loss in Primary Care in Louisiana

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 803 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
803
试验地点
2
主要终点
Body Weight (Percent Change)

研究概览

简要总结

The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Half of the clinics received a behavioral intervention delivered in a primary care setting and half of the clinics received usual care.

详细描述

This study is a cluster-randomized, two-arm controlled trial in primary care settings. A total of 18 primary care clinics inclusive of low income populations with a high percentage of African Americans from urban and rural areas across Louisiana were randomized to either 1) intervention or 2) usual care. The sample includes 803 patients with obesity (BMI 30-50 kg/m2) (18 clinics, median of 40.5 patients / clinic). The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Patients in the intervention arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the intervention arm received a series of webinars on obesity science to help them manage and treat obese patients. Patients assigned to the usual care arm will continue to interact with their Primary Care Practitioner according to their usual schedule, and will receive a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid Services (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure will be sent to the Primary Care Practitioners each year. Patients in both arms were assessed on primary and secondary outcome measures at baseline, and at 6, 12, 18 and 24 months of intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20.0 - 75.0 years
  • BMI 30.0 - 50.0 kg/m2
  • Able to provide written informed consent
  • Willing to change diet, physical activity and weight
  • Patient of a participating clinic
  • Able to participate in scheduled sessions

排除标准

  • Currently participating in a weight loss program
  • Current use of weight loss medication or recent weight loss (>10 lbs in last 6 months)
  • Plans to move from the area within 2 years
  • Given birth within the past year, is currently pregnant or plans to become pregnant within 2 years
  • Past bariatric surgery or plans for bariatric surgery within 2 years
  • Current major depression
  • History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia)
  • Hospitalization for mental disorder or substance abuse in the previous year
  • Active cancer (except prostate, skin and thyroid if approved by physician)
  • Serious arrhythmias or cardiomyopathy
  • Severe congestive heart failure
  • Stroke or heart attack in previous six months
  • Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease(i.e. Crohn's disease or ulcerative colitis)
  • Disease that is life threatening or that can interfere with or be aggravated by exercise or weight loss
  • Discretion of primary care physician or principal investigator

结局指标

主要结局

Body Weight (Percent Change)

时间窗: Percent (%) Change from Baseline to Month 24

Body weight is measured in light indoor clothes.

次要结局

  • Systolic Blood Pressure(Change from Baseline to Month 24)
  • Total Cholesterol(Change from Baseline to Month 24)
  • IWQOL-L Public Distress(Change from Baseline to Month 24)
  • PROMIS-29 Depression(Change from Baseline to Month 24)
  • PROMIS-29 Fatigue(Change from Baseline to Month 24)
  • IWQOL-L Sexual Life(Change from Baseline to Month 24)
  • Diastolic Blood Pressure(Change from Baseline to Month 24)
  • Fasting Plasma Glucose(Change from Baseline to Month 24)
  • PROMIS-29 Sleep Disturbance(Change from Baseline to Month 24)
  • PROMIS-29 Pain Interference(Change from Baseline to Month 24)
  • Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function(Change from Baseline to Month 24)
  • PROMIS-29 Anxiety(Change from Baseline to Month 24)
  • PROMIS-29 Pain Intensity(Change from Baseline to Month 24)
  • Waist Circumference(Change from Baseline to Month 24)
  • PROMIS-29 Social Functioning(Change from Baseline to Month 24)
  • IWQOL-L Physical Function(Change from Baseline to Month 24)
  • Body Weight (Absolute Change)(Absolute (kg) Change from Baseline to Month 24)
  • Triglycerides(Change from Baseline to Month 24)
  • Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score(Change from Baseline to Month 24)
  • IWQOL-L Self Esteem(Change from Baseline to Month 24)
  • IWQOL-L Work/Daily Activity(Change from Baseline to Month 24)
  • Low-density Lipoprotein Cholesterol(Change from Baseline to Month 24)
  • High-density Lipoprotein Cholesterol(Change from Baseline to Month 24)

研究者

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

Peter T. Katzmarzyk

Associate Executive Director for Population and Public Health Sciences

Pennington Biomedical Research Center

研究点 (2)

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