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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.


Recruitment information / eligibility

Status Completed
Enrollment 543
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Parents who attend EFNEP programs in the states of WA and CO. Exclusion Criteria: - Parents with children younger than age 2 and older than age 8 will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutrition program with in-person parental feeding content
Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
Nutrition program with online parental feeding content
Participants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online.

Locations

Country Name City State
United States Colorado State University Fort Collins Colorado
United States Washington State University Pullman Washington

Sponsors (3)

Lead Sponsor Collaborator
Baylor College of Medicine Colorado State University, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Responsive Feeding from the modified Child Feeding Questionnaire Five subscales measuring responsiveness, restriction, use of food as reward, monitoring, and pressure to eat will be assessed using a 5-point Likert scale. Parents will report on these constructs that assess responsive feeding. Up to 12-month follow up
Primary Providing Structure from the modified Child Feeding Questionnaire Seven subscales measuring parent decides on portions, family meals, serves measured portions, child helps prepare, eat whenever, indulgent feeding, and eat at regular times will be assessed using a 5-point Likert scale. Parents will report on these constructs that assess responsive feeding. Up to 12-month follow up
Primary Novel Foods from the modified Child Feeding Questionnaire Four subscales measuring encouraging exploration, offering new foods, urging new foods, and low pressure strategies for encouragement will be assessed using a 5-point Likert scale. Parents will report on these constructs that assess responsive feeding. Up to 12-month follow up
Secondary Parental Knowledge Questionnaire A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed. Up to 12-month follow up
Secondary Child Eating Behaviors Parental report of child eating behaviors Up to 12-month follow up
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