跳至主要内容
临床试验/NCT02427100
NCT02427100已完成不适用

Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults: A Pilot Study

University of Texas Southwestern Medical Center0 个研究点目标入组 32 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups

研究概览

简要总结

The proposed study will utilize a randomized controlled trial design to pilot-test a 4-week shelter-based diet and physical activity intervention in a sample of homeless adults residing in the transitional shelter at The Bridge Homeless Assistance Center in Dallas, TX (N = 50). Participants will be randomly assigned to a diet/physical activity intervention group (n = 25) or a paid assessment-only control group (n = 25). Three intervention strategies will be employed: 1) computer-tailored newsletters adapted from a program supported for use in other populations, 2) the distribution of fruit and vegetable snacks directly to individuals, and 3) the provision of pedometers and walking goals. Thus, the primary aim of the proposed study is to 1) evaluate the feasibility and effectiveness (relative to an assessment-only control group) of a shelter-based intervention designed to improve dietary intake and increase physical activity among homeless individuals. The main study outcomes will be average daily fruit and vegetable consumption and objective pedometer/ accelerometer assessment of physical activity (assessed weekly) over the 4-week study period, and at a follow-up assessment 4 weeks after the conclusion of the intervention. Secondary aims will focus on: 2) identifying intervention-related differences (relative to the control group) in indicators of physical health including blood pressure, weight, body mass index (BMI), waist circumference, and other dietary variables (i.e., caloric intake, meals consumed outside of the shelter, daily fat and fiber intake) and 3) identifying psychosocial variables associated with dietary quality and physical activity.

详细描述

Study Overview. The proposed study will take place at "The Bridge" homeless shelter in Dallas, TX. The study intervention will use a randomized controlled trial design, and an additional 50 transitional shelter residents will be recruited to participate in the proposed 8-week study (4-week intervention; 4-week post-intervention follow-up visit). Transitional Shelter residents stay in "semi-private" rooms for an average of 5 months while staff works to secure more permanent housing. Interested and eligible participants will be randomized to either 1) a 4-week shelter-based diet or physical activity intervention, or 2) standard care (paid assessment only). Participants will be asked to complete weekly assessments of diet, physical activity, stress, readiness to change, and other relevant variables throughout the 4-week intervention period, in addition to a 4-week post-intervention follow-up. Participants will be compensated with gift cards for each of 6 visits. Participants assigned to the control group will receive tailored newsletters and pedometers with walking goals at the final follow-up visit. Laptop and tablet computers equipped with Questionnaire Development System software will be transported to the shelter for all intervention and assessment sessions.

Intervention Components Education. A series of four computer-tailored newsletters will be generated for each individual participant using TailorTool, a web-based program hosted and maintained at the University of North Carolina (described below; see also www.chaicore). Newsletter topics include healthy eating (especially the importance of fruit/vegetable consumption), physical activity, and weight management. Using information collected at baseline, newsletters will be tailored to individual participants based on demographic, psychosocial, behavioral, and community resource information. The program will be adapted to include graphics and testimonials relevant to the sheltered homeless population. Strategies for healthy food selection and community resources available to shelter residents will be provided.

The newsletters will include of a set of tailored "stories" in the following formats designed to appeal to the homeless shelter population: Testimonials (tailored to gender) by residents of the shelter who have made changes in weight and lifestyle. An advice column (tailored to behavior-specific barriers), that uses a "Dear Abby" format in which an expert (e.g., dietician) answers questions tailored to participant-selected barriers. Behavioral feedback (current behavior compared to recommendations) will be provided. Stage of change-based action plan (tailored to stage of change, current behavior) will offer a specific set of steps that are stage-matched to participant readiness to change related to each behavior. The importance of social support (tailored to behavior-specific social support/network characteristics) will be discussed by providing a targeted story about how social support (tailored to type of support and person most helpful to give support) has helped someone make healthy changes. The values section (tailored to participant-selected core values) discusses the participant-selected values and suggests possible ways that these values may be related to the target behavior. Community resources will provide information and tips tailored to the shelter, such as group session information, healthful choices in the cafeteria (and other common food sources), maximizing SNAP food benefits for optimal nutrition, good nutrition with a limited income, walking groups, contact information, and community resources. Participants assigned to standard care will receive the tailored newsletters after they complete the final follow-up assessment.

TailorTool is a software tool created by the UNC CHAI (Communication for Health Applications and Interventions) Core that enables the creation and delivery of tailored communications in a dynamically generated pdf newsletter format. The tool generates intervention material such as individual feedback on targeted behavior(s) and variables such as relevant demographics, psychosocial factors, and barriers. Templates of various page lay-out possibilities allow individualization of the look of the newsletters. Messages are drawn from a message library of text files of varying lengths depending on the needs of the research study. Graphics can be imported into the various template pages. Newsletters can vary in length and can be personalized with names of participants. Following completion of an online survey the newsletter(s) are created in a pdf format for reading, saving, and/or printing by the participant. Each subsequent newsletter can be available immediately or timed for release to fit the timeline of the intervention.

From a technical perspective, the web application for the automated web-to-print system is programmed to run under a Windows operating system, using open-source software and a MS SQL database. The core of the system is a server-side application, with the website consisting of ASP pages (Active Server Pages), which interface with the application using XML. The backend application is heavily database-driven with everything from survey questions and skip patterns (i.e. which survey answers can cause later questions to be disabled, as described above; the actual disabling takes place client-side, with dynamically-generated javascript code) to the newsletter content and tailoring logic stored in, and thus configurable via, XML files. Participants' survey-response data are stored in the database. The dynamic generation of the print newsletters in pdf format is done within the application using a dynamic-link library installed on the system.

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
None

入排标准

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

入选标准

  • at least 18 years of age,
  • willing and able to attend all study visits,
  • earn a score ≥ 4 on the REALM-SF indicating > 6th grade literacy level,
  • physically able to walk and/or run for physical activity,
  • resident of the transitional shelter (must show Bridge ID badge), and
  • have been living in the transitional shelter for ≤ 3 months.

排除标准

  • < 18 years of age,
  • unwilling or unable to attend all study visits,
  • earn a score < 4 on the REALM-SF indicating ≤ 6th grade literacy level,
  • unable to participate in the walking/running component of the intervention (i.e., mobility impairments),
  • are not residents of the transitional shelter (or does not have a Bridge ID badge) or
  • have been living in the shelter for > 2 months.

研究组 & 干预措施

Control Group

No Intervention

Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

Intervention Group

Active Comparator

Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.

干预措施: Diet/Physical Activity (Behavioral)

结局指标

主要结局

Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups

时间窗: 4 weeks post-enrollment

Accelerometer-Measured Physical Activity: Moderate to Vigorous Intensity Physical Activity

时间窗: Daily over 4 weeks (repeated measures analysis; day 15 excluded because accelerometers were replaced with newly charged accelerometers)

Linear Mixed Model (LMM) methods were used to evaluate differences in daily accelerometer-measured MVPA measured over a 28-day period using SAS version 9.4. Daily accelerometer measured activity was NOT averaged or summarized into a single variable. Rather, daily activity summaries over 28 days were compared between the intervention and control group (see Kendzor et al., 2017, Journal of Physical ACtivity and Health).

次要结局

未报告次要终点

研究者

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

Darla Elizabeth Kendzor

Assistant Professor

The University of Texas Health Science Center, Houston

相似试验