- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03170700
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Colorado
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Fort Collins, Colorado, 미국, 80523
- Colorado State University
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Washington
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Pullman, Washington, 미국, 99164
- Washington State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control
Participants will receive a nutrition program without parental feeding content.
They will attend the nutrition program (Eating Smart • Being Active).
|
|
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실험적: In-person
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.
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실험적: Online
Nutrition program with online parental feeding content.
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Participants will attend the nutrition program (Eating Smart • Being Active).
They will access parental feeding content online.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Responsive Feeding from the modified Child Feeding Questionnaire
기간: 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.
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Up to 12-month follow up
|
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Providing Structure from the modified Child Feeding Questionnaire
기간: 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.
|
Up to 12-month follow up
|
|
Novel Foods from the modified Child Feeding Questionnaire
기간: 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.
|
Up to 12-month follow up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parental Knowledge Questionnaire
기간: 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.
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Up to 12-month follow up
|
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Child Eating Behaviors
기간: Up to 12-month follow up
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Parental report of child eating behaviors
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Up to 12-month follow up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sheryl O Hughes, PhD, Baylor College of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .