We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Online Videos and New Feeding Content to Enhance a Current EFNEP Program

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: NCT03170700
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : May 23, 2022
Sponsor:
Collaborators:
Washington State University
Colorado State University
Information provided by (Responsible Party):
Sheryl Hughes, Baylor College of Medicine

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).

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Nutrition program with in-person parental feeding content Behavioral: Nutrition program with online parental feeding content Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Assessments will be conducted by staff blind to group membership.
Primary Purpose: Prevention
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
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

Arm Intervention/treatment
No Intervention: Control
Participants will receive a nutrition program without parental feeding content. They will attend the nutrition program (Eating Smart • Being Active).
Experimental: In-person
Nutrition program with in-person parental feeding content.
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.

Experimental: Online
Nutrition program with online parental feeding content.
Behavioral: Nutrition program with online parental feeding content
Participants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online.




Primary Outcome Measures :
  1. Responsive Feeding from the modified Child Feeding Questionnaire [ Time Frame: Up to 12-month follow up ]
    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.

  2. Providing Structure from the modified Child Feeding Questionnaire [ Time Frame: Up to 12-month follow up ]
    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.

  3. Novel Foods from the modified Child Feeding Questionnaire [ Time Frame: Up to 12-month follow up ]
    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 :
  1. Parental Knowledge Questionnaire [ Time Frame: Up to 12-month follow up ]
    A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.

  2. Child Eating Behaviors [ Time Frame: Up to 12-month follow up ]
    Parental report of child eating behaviors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170700


Locations
Layout table for location information
United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80523
United States, Washington
Washington State University
Pullman, Washington, United States, 99164
Sponsors and Collaborators
Baylor College of Medicine
Washington State University
Colorado State University
Investigators
Layout table for investigator information
Principal Investigator: Sheryl O Hughes, PhD Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sheryl Hughes, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03170700    
Other Study ID Numbers: H-36455
2015-68001-23311 ( Other Identifier: USDA )
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheryl Hughes, Baylor College of Medicine:
preschool
eating behaviors
family
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight