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

NCT02427100 | Completed Results

• 1 other identifier: STU 062014-031
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dietary Modification; Physical Activity

Keywords

Homeless; Randomized Controlled Trial; Diet; Physical Activity

Outcome Measures

Primary Outcomes (2)

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

  4 weeks post-enrollment

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

  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).

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

Study Arms (2)

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.

Behavioral: Diet/Physical Activity

Interventions

Diet/Physical Activity BEHAVIORAL

Diet/Physical Activity Intervention

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• The University of Texas Health Science Center, Houston: collaborator
• American Cancer Society, Inc.: collaborator
• Simmons Cancer Center: collaborator

Related Links

• Link to publication

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Darla Kendzor, Associate Professor
• Organization: The University of Oklahoma Health Sciences Center

Darla-Kendzor@ouhsc.edu

(405) 271-8001

Study Officials

• Darla E. Kendzor, Ph.D.

  The University of Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: April 27, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share