Trial Outcomes & Findings for Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults (NCT NCT02427100)
NCT ID: NCT02427100
Last Updated: 2019-05-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
4 weeks post-enrollment
Results posted on
2019-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
Intervention Group
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 Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Intervention Group
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 Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults
Baseline characteristics by cohort
| Measure |
Control Group
n=15 Participants
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
n=17 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47.27 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
49.35 years
STANDARD_DEVIATION 6.34 • n=7 Participants
|
48.38 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
BMI, Mean (SD)
|
29.38 kg/m²
STANDARD_DEVIATION 7.27 • n=5 Participants
|
30.20 kg/m²
STANDARD_DEVIATION 7.62 • n=7 Participants
|
29.82 kg/m²
STANDARD_DEVIATION 7.35 • n=5 Participants
|
|
Fruit/Vegetables, cups (past 24 hours)
|
2.60 cups
STANDARD_DEVIATION 1.61 • n=5 Participants
|
3.10 cups
STANDARD_DEVIATION 2.10 • n=7 Participants
|
2.87 cups
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Physical Activity Guidelines, n (based on self-report)
Not Meeting Guidelines
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Physical Activity Guidelines, n (based on self-report)
Meeting Guidelines
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-enrollmentPopulation: 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).
Outcome measures
| Measure |
Control Group
n=14 Participants
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
n=14 Participants
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
|
|---|---|---|
|
Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups
|
2.08 cups
Standard Error .74
|
3.56 cups
Standard Error .74
|
PRIMARY outcome
Timeframe: Daily over 4 weeks (repeated measures analysis; day 15 excluded because accelerometers were replaced with newly charged accelerometers)Population: All participants included.
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).
Outcome measures
| Measure |
Control Group
n=15 Participants
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
n=17 Participants
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
|
|---|---|---|
|
Accelerometer-Measured Physical Activity: Moderate to Vigorous Intensity Physical Activity
|
41 daily minutes
Interval 11.0 to 64.0
|
60 daily minutes
Interval 28.0 to 107.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Darla Kendzor, Associate Professor
The University of Oklahoma Health Sciences Center
Phone: (405) 271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place