Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03170700 |
Other study ID # |
H-36455 |
Secondary ID |
2015-68001-23311 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 11, 2017 |
Est. completion date |
October 30, 2020 |
Study information
Verified date |
May 2022 |
Source |
Baylor College of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to further increase the impact of a validated and widely-used
Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices
resulting in the development of healthier patterns of child eating behavior and food intake.
Additionally, the effectiveness of two delivery strategies for adding feeding video-based
content will be examined (in-person versus online lessons).
Description:
During Phase I of the project (first two years), the leadership team composed of both
research and extension investigators will work with the media production team to edit the
SEEDS videotapes to meet the needs of the current project and to develop the website and
activities for use in the online condition. Phase II (second three years) will be a large
scale evaluation of this program. In this phase, classes of EFNEP participants in Colorado
and Washington will be randomly assigned to one of three conditions: 1) Eating Smart • Being
Active alone (control); 2) Eating Smart • Being Active plus feeding videos at the weekly
EFNEP sessions, plus facilitated group discussion (in-person); or 3) Eating Smart • Being
Active plus online videos and activities, (online). Pre- and post-program assessments, 6- and
12-month follow ups will be conducted to assess responsive feeding, providing structure, food
exploration, child eating behaviors, parent knowledge, and child dietary intake. Child
dietary intake will be obtained on a sub-sample of 90 participants. In Phase III, the
investigators will begin dissemination.
A total of 543 participants were recruited in five locations to participate in the project:
262 from three counties in Colorado and 281 from three counties in Washington (English and
Spanish participants). A total of 4 to 10 mothers were recruited for each group. After
recruitment, groups were randomly assigned to the three conditions ensuring a relatively
equal number of participants per condition.
Data from children who have any kind of food allergies or diabetes or are on special diet
will be excluded from the analyses.
To ensure program fidelity, program educators will complete implementation checklists, and
20% of the sessions will be attended by an additional grant staff member to conduct
implementation observations and assess participant engagement. Detailed records of
participant attendance will be collected to assess dosage effects and attrition. All
assessments will be conducted by grant project staff blind to the group status of the
participants. Retention of participants will be maximized using strategies such as obtaining
multiple phone numbers for each family; obtaining external contact information for siblings
and close friends; sending interim reminders with the goal of fostering contact should the
family move; and phone calls, emails or letters between data collection points to each
family.