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Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427100
Recruitment Status : Completed
First Posted : April 27, 2015
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
The University of Texas Health Science Center, Houston
American Cancer Society, Inc.
Simmons Cancer Center
Information provided by (Responsible Party):
Darla Elizabeth Kendzor, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE December 17, 2014
First Posted Date  ICMJE April 27, 2015
Results First Submitted Date  ICMJE September 7, 2016
Results First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Study Start Date  ICMJE April 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups [ Time Frame: 4 weeks post-enrollment ]
  • Accelerometer-Measured Physical Activity: Moderate to Vigorous Intensity Physical Activity [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
  • Automated Self-Administered 24-Hour Dietary Recall [ Time Frame: 4 weeks post-enrollment ]
  • Accelerometer-Measured Physical Activity [ Time Frame: 4 weeks post-enrollment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults
Official Title  ICMJE Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults: A Pilot Study
Brief Summary 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.
Detailed Description

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.

Fruit/Vegetable Snacks. We will provide transitional shelter residents assigned to the intervention group with two pieces of fruit and/or vegetables each weekday. We will offers fruits/vegetables that are easy to distribute and do not require preparation other than washing or packaging in a bag (e.g., apples, bananas, oranges, baby carrots, broccoli, cauliflower). Foods will be purchased by study staff, stored at The Bridge in the cafeteria refrigerator, and offered to participants assigned to the intervention group in the cafeteria at specified times twice daily as mid-morning and mid-afternoon snacks. Note that because the snacks will be offered between regular mealtimes, only intervention participants will be in the cafeteria to receive the fruit/vegetable snacks. In addition, snacks will be consumed in the cafeteria during specified snack times because the shelter does not allow food in other areas of the building. Study staff will follow all relevant shelter food safety practices. It is hypothesized that study participants will consume more fruit and vegetables and eat fewer meals/snacks from fast food restaurants and convenience stores than individuals assigned to the control group. This is a practical, simple, and direct approach to increasing fruit/vegetable consumption, as shelter residents obtain most of their meals from the shelter and offering snacks may discourage residents from seeking less healthful foods elsewhere.

Pedometers. Walking is a practical way to achieve physical activity recommendations among individuals experiencing homelessness, as it does not require any specific equipment and may be a common activity and means of transportation in this population. Pedometers are small and inexpensive devices that measure steps walked per day. All study participants will be provided with a New Lifestyles NL-1000 pedometer/ accelerometer, which measures steps, distance, and activity minutes and is equipped with a 7-day memory and clock. Those randomly assigned to the intervention will be instructed to aim for 10,000 steps per day, but to focus on gradually increasing their steps each day (rather than achieving 10,000 steps right away) if they are currently very sedentary. In addition, intervention participants will be provided with information about the Back on My Feet program, which is offered at the Bridge shelter. Program members meet for a group run/walk 3 times per week on Monday, Wednesday, and Friday mornings. Intervention participants will be instructed to wear their pedometer during waking hours each day, and asked to return each week over a 4-week period (4 visits total) so that study staff may record the daily step counts. We will additionally ask participants to return for a 4-week post-intervention follow-up (we will remind participants to wear their pedometer the week prior to the assessment). Individuals assigned to the control group will provided with a pedometer and step goals after the final follow-up visit. All participants may keep their pedometer after their participation in the study is completed. Note that intervention and control group participants will be provided with accelerometers at the beginning of the study to provide an objective measure of physical activity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dietary Modification
  • Physical Activity
Intervention  ICMJE Behavioral: Diet/Physical Activity
Diet/Physical Activity Intervention
Study Arms  ICMJE
  • No Intervention: Control Group
    Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.
  • Active Comparator: Intervention Group
    Intervention participants will receive 4 weekly newsletters, a pedometer with walking advice, and twice daily fruit/vegetable snacks during weekdays.
    Intervention: Behavioral: Diet/Physical Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2015)
50
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. < 18 years of age,
  2. unwilling or unable to attend all study visits,
  3. earn a score < 4 on the REALM-SF indicating ≤ 6th grade literacy level,
  4. unable to participate in the walking/running component of the intervention (i.e., mobility impairments),
  5. are not residents of the transitional shelter (or does not have a Bridge ID badge) or
  6. have been living in the shelter for > 2 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427100
Other Study ID Numbers  ICMJE STU 062014-031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Darla Elizabeth Kendzor, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • The University of Texas Health Science Center, Houston
  • American Cancer Society, Inc.
  • Simmons Cancer Center
Investigators  ICMJE
Principal Investigator: Darla E. Kendzor, Ph.D. The University of Texas Health Science Center
PRS Account University of Texas Southwestern Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP