Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition program with in-person parental feeding content
Nutrition program with online parental feeding content
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood focused on measuring preschool, eating behaviors, family
Eligibility Criteria
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.
Sites / Locations
- Colorado State University
- Washington State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
In-person
Online
Arm Description
Participants will receive a nutrition program without parental feeding content. They will attend the nutrition program (Eating Smart • Being Active).
Nutrition program with in-person parental feeding content.
Nutrition program with online parental feeding content.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Parental Knowledge Questionnaire
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
Child Eating Behaviors
Parental report of child eating behaviors
Full Information
NCT ID
NCT03170700
First Posted
May 8, 2017
Last Updated
May 20, 2022
Sponsor
Baylor College of Medicine
Collaborators
Washington State University, Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03170700
Brief Title
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Official Title
Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Washington State University, Colorado State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
preschool, eating behaviors, family
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of three conditions: 1) Nutrition Program (Eating Smart • Being Active) alone (control); 2) Nutrition program with parental feeding content (In-person); or 3) Nutrition program with parental feeding content (online).
Masking
Outcomes Assessor
Masking Description
Assessments will be conducted by staff blind to group membership.
Allocation
Randomized
Enrollment
543 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive a nutrition program without parental feeding content. They will attend the nutrition program (Eating Smart • Being Active).
Arm Title
In-person
Arm Type
Experimental
Arm Description
Nutrition program with in-person parental feeding content.
Arm Title
Online
Arm Type
Experimental
Arm Description
Nutrition program with online parental feeding content.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition program with in-person parental feeding content
Intervention Description
Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition program with online parental feeding content
Intervention Description
Participants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online.
Primary Outcome Measure Information:
Title
Responsive Feeding from the modified Child Feeding Questionnaire
Description
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.
Time Frame
Up to 12-month follow up
Title
Providing Structure from the modified Child Feeding Questionnaire
Description
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.
Time Frame
Up to 12-month follow up
Title
Novel Foods from the modified Child Feeding Questionnaire
Description
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.
Time Frame
Up to 12-month follow up
Secondary Outcome Measure Information:
Title
Parental Knowledge Questionnaire
Description
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
Time Frame
Up to 12-month follow up
Title
Child Eating Behaviors
Description
Parental report of child eating behaviors
Time Frame
Up to 12-month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheryl O Hughes, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
Washington State University
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35708621
Citation
Hughes SO, Power TG, Baker SS, Barale KV, Aragon MC, Lanigan JD, Parker L, Silva Garcia K, Auld G, Johnston CA, Micheli N. Short-Term Efficacy of a Childhood Obesity Prevention Program Designed to Pair Feeding Content With Nutrition Education. Child Obes. 2023 Jun;19(4):239-248. doi: 10.1089/chi.2022.0030. Epub 2022 Jun 16.
Results Reference
derived
Learn more about this trial
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
We'll reach out to this number within 24 hrs