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临床试验/NCT03418701
NCT03418701已完成不适用

Culturally Sensitive Primary Care Clinic-based Interventions by Community Health Workers and Trained Physicians to Promote and Sustain Weight Loss Among Obese Black Women Patients

University of Florida2 个研究点 分布在 1 个国家目标入组 683 人开始时间: 2018年4月1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
683
试验地点
2
主要终点
Weight Loss

研究概览

简要总结

The study will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program is being implemented by Community Health Workers at the primary care centers and followed by either of two physician-implemented behavioral counseling programs to prevent weight gain--programs that are implemented quarterly over 12 months.

详细描述

Objectives: Aim 1 was to evaluate the effectiveness of the community health worker (CHW)-implemented, clinic-located, evidence-based, 6-month Health-Smart Weight Loss (HSWL) Program, as indicated by participants' mean weight loss. Aim 2 was to compare the outcomes of the following two 12-month, clinic-based weight loss maintenance programs implemented by patients' physicians after these patients completed the 6-month weight loss intervention: the physician-implemented Patient-Centered, Culturally Sensitive Weight Loss Maintenance (PCCS-WLM) intervention, and the Standard Behavioral Weight Loss Maintenance (SB-WLM) intervention. These two weight loss maintenance interventions differ in that the physicians who implemented the PCCS-WLM intervention were trained to display patient-identified, culturally sensitive behaviors and attitudes when talking with patients about their weight and to support patients' engagement in health promoting (health-smart) behaviors in order to promote patients' weight loss maintenance, whereas physicians in the SB-WLM intervention were trained to use behavioral change principles and skills as well as motivational interviewing approaches to behavior change in order to promote patients' weight loss maintenance. Aim 3 was to implement and evaluate a medical assistant-led program to integrate CHWs into health care teams.

Methods: Participants were recruited from 21 primary care practices operated by an academic medical center. Participants' eligibility criteria were: Black women ages 21 years or older with a BMI of 30 kg/m2 or higher who had at least 2 clinic visits in the previous 24 months and were ready to change their diet and physical activity level.

All participants received the 6-month CHW-implemented HSWL Program to address Aim 1. Therefore, results from baseline to 6 months are presented as one group. The study was constructed as a cluster-randomized trial to address Aim 2; thus, after the HSWL Program involving all participants was completed, clinics were randomized to the either the SB-WLM group or the PCCS-WLM group. Consequently, results after 6 months are presented separately for the two groups. Clinics were randomized with patients nested within clinic.

To address Aim 1, a paired samples t-test and confidence interval of the proportion of the sample that achieved 5% or more weight loss by 6 months were used. To address Aim 2, a logistic regression with participants nested within clinics and Aim 2 study group as the independent variable was used. To address Aim 3, which was to evaluate integration of CHWs into the health care team, a virtual meeting was held with the CHWs who remained at the end of the study (n=8) for the purpose of asking exploratory semi-structured questions about the clinical staff behaviors that helped them feel or not feel integrated into the clinical team and to identify what would improve and/or sustain integration of CHWs into the clinical team. Content analysis using the constant comparison method was applied to the responses of the CHWs to the semi-structured questions asked. The communications and follow-through subscale of the TeamSTEPPS Assessment Tool was used to assess communication among the clinic staff as viewed by the participating clinic staff as a group and CHWs as a group. Mean ratings of responses to this subscale for each of these groups were calculated.

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
21 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • African American/black
  • Age 21 years or older
  • BMI range ≥ 30kg/m2 (5) active patient of a participating clinic (i.e., at least 2 clinic visits in the last 24 months)
  • Willing and ready to change one's diet and physical activity level
  • Willing to be randomized to either of the two weight-loss maintenance intervention groups

排除标准

  • Any serious medical condition that likely affects weight, such as end stage renal disease or cancer
  • Prior bariatric surgery within the last 5 years or plans for this surgery in the next 2 years
  • Use of prescription or over-the-counter weight-loss medication within the last 6 months
  • Pregnant or plan to get pregnant within the next 2 years
  • Plan to relocate from the area within the next 2 years
  • Having had unintentional weight loss (>or = to 5% of body weight) within 6 months prior to enrollment
  • Taking a daily dose of oral corticosteroid antipsychotic (clozapine, olanzapine, or risperidone) for less than 6 months

结局指标

主要结局

Weight Loss

时间窗: 6 months

percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)

Weight Loss Maintenance

时间窗: 18 months

percentage of participants will maintain initial weight loss or show continued weight loss

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Health-Smart for Weight Loss at UF Jax Clinics | 临床试验