Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Dietary Modification
Physical Activity
Intervention Behavioral: Diet/Physical Activity
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

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

Diet/Physical Activity: Diet/Physical Activity Intervention

Period Title: Overall Study
Started 15 17
Completed 15 15
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
Arm/Group Title Control Group Intervention Group Total
Hide Arm/Group Description Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

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

Diet/Physical Activity: Diet/Physical Activity Intervention

Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
47.27  (9.88) 49.35  (6.34) 48.38  (8.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
6
  40.0%
2
  11.8%
8
  25.0%
Male
9
  60.0%
15
  88.2%
24
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
American Indian or Alaska Native
1
   6.7%
0
   0.0%
1
   3.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  80.0%
15
  88.2%
27
  84.4%
White
1
   6.7%
2
  11.8%
3
   9.4%
More than one race
1
   6.7%
0
   0.0%
1
   3.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 32 participants
15 17 32
BMI, Mean (SD)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 15 participants 17 participants 32 participants
29.38  (7.27) 30.20  (7.62) 29.82  (7.35)
Fruit/Vegetables, cups (past 24 hours)  
Mean (Standard Deviation)
Unit of measure:  Cups
Number Analyzed 15 participants 17 participants 32 participants
2.60  (1.61) 3.10  (2.10) 2.87  (1.87)
Physical Activity Guidelines, n (based on self-report)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Not Meeting Guidelines 8 6 14
Meeting Guidelines 7 11 18
1.Primary Outcome
Title Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups
Hide Description [Not Specified]
Time Frame 4 weeks post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
In the control group (n = 15), 1 participant who attended the visit did not complete a dietary recall (leaving a total of 14 participants). In the intervention group, 2 participants did not attend the visit, and 1 who attended did not complete a dietary recall (leaving a total of 14 participants).
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

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

Diet/Physical Activity: Diet/Physical Activity Intervention

Overall Number of Participants Analyzed 14 14
Least Squares Mean (Standard Error)
Unit of Measure: cups
2.08  (.74) 3.56  (.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Accelerometer-Measured Physical Activity: Moderate to Vigorous Intensity Physical Activity
Hide Description 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).
Time Frame Daily over 4 weeks (repeated measures analysis; day 15 excluded because accelerometers were replaced with newly charged accelerometers)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included.
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

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

Diet/Physical Activity: Diet/Physical Activity Intervention

Overall Number of Participants Analyzed 15 17
Median (Inter-Quartile Range)
Unit of Measure: daily minutes
41
(11 to 64)
60
(28 to 107)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .00036
Comments The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.
Method Mixed Models Analysis
Comments A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Control participants will be paid for assessments. They will receive study newsletters and a pedometer with advice after the final follow-up visit.

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

Diet/Physical Activity: Diet/Physical Activity Intervention

All-Cause Mortality
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Darla Kendzor, Associate Professor
Organization: The University of Oklahoma Health Sciences Center
Phone: (405) 271-8001 ext 50478
EMail: Darla-Kendzor@ouhsc.edu
Layout table for additonal information
Responsible Party: Darla Elizabeth Kendzor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02427100    
Other Study ID Numbers: STU 062014-031
First Submitted: December 17, 2014
First Posted: April 27, 2015
Results First Submitted: September 7, 2016
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019