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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

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.

Condition or disease Intervention/treatment Phase
Dietary Modification Physical Activity Behavioral: Diet/Physical Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults: A Pilot Study
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Diet/Physical Activity
Diet/Physical Activity Intervention




Primary Outcome Measures :
  1. Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups [ Time Frame: 4 weeks post-enrollment ]
  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427100


Sponsors and Collaborators
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
American Cancer Society, Inc.
Simmons Cancer Center
Investigators
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Principal Investigator: Darla E. Kendzor, Ph.D. The University of Texas Health Science Center
Additional Information:
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Responsible Party: Darla Elizabeth Kendzor, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02427100    
Other Study ID Numbers: STU 062014-031
First Posted: April 27, 2015    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Darla Elizabeth Kendzor, The University of Texas Health Science Center, Houston:
Homeless
Randomized Controlled Trial
Diet
Physical Activity