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Healthy Babies Through Infant Centered Feeding (HB)

2014년 5월 30일 업데이트: Mildred Horodynski, Michigan State University
Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. The goal of the project is to provide an educational intervention that fosters appropriate maternal responsiveness, feeding styles, and feeding practices via infant-centered feeding.

연구 개요

상세 설명

The long-term goal of this integrated project is to contribute to curbing the rising rates of childhood obesity through an effective, multi-component, relationship skill-building and educational intervention that fosters infant-centered feeding to promote appropriate maternal responsiveness, feeding styles, and feeding practices as infants transition to solid foods.

Research Objectives: To evaluate effectiveness of Healthy Babies (HB) compared to the Expanded Food and Nutrition Education Program (EFNEP) at two points in time (when the infant is 6 and 12 months of age) for mothers of infants on maternal responsiveness, feeding style, and feeding practices as infants' transition to solid foods, and to compare infant feeding self-regulation and growth pattern of infants at 6 and 12 months of age between the two groups, HB and EFNEP.

Hypothesis: Compared to mothers of infants who receive traditional EFNEP lessons, mothers who receive HB lessons will achieve an improvement (when the infant is 6 months old that is sustained over time when the infant is 12 months of age) on:

  • Maternal responsiveness (measured by appropriately interpreting and responding to infant cues when transitioning their infants to solid foods on the Parent-Child Interaction-Feeding Scale [PCI-F]).
  • Maternal feeding styles (measured by feeding beliefs and behaviors on the Infant Feeding Styles Questionnaire).
  • Feeding practices (measured by use of appropriate feeding practices when transitioning their infants to solid foods on the PCI-F).

Research Question: How do infants in the HB (intervention) group compare to the infants in the traditional EFNEP group when the infant is 6 and 12 months old on:

  • Infant feeding self-regulation (measured by clarity of cues and feeding responsiveness on the PCI-F).
  • Infant growth patterns (measured by growth charts).

Extension Objective: To evaluate feasibility, fidelity, and educational effectiveness of the HB intervention. (Process Evaluation)

Research Question: What is the feasibility of integration within Extension by paraprofessionals who deliver HB and for mothers of infants' who receive the HB lessons, related to:

  • Paraprofessionals' training, ability to deliver the intervention (fidelity), and satisfaction with the intervention; and
  • Mothers' acceptance (recruitment), completion (retention), and satisfaction with the intervention.

Research Question: What is the educational effect of the intervention on maternal knowledge, attitudes, and self-efficacy related to infant feeding?

Research Design. The study will use a randomized clinical trial design in which participants from Michigan (MI) and Colorado (CO) will be randomly assigned to the HB intervention or control (EFNEP) group. The HB intervention, delivered by paraprofessionals (educators), is designed to foster appropriate maternal responsiveness, feeding style, and feeding practices. Participants will be blinded to their group assignment. Data will be collected at three time points by a separate data collection team (not educators): baseline (before the first lesson), follow-up (when infant is six months old), and post follow-up (when infant is 12 months old). These time points have been selected based on the infant's age, such that when an infant is six months old, this is the usual time frame when introducing solid food is recommended to be initiated for all infants, and at 12 months, infants should have an established eating pattern of solid foods. Thus, these points in time were selected rather than immediately following the lessons for consistency in infant age. The age of the infant at time of enrollment will be standardized for timing of the intervention, such that the intervention will begin for all infants between 1 and 4 months of age. Three time points are included to make statistical comparisons and assess the sustainability of changes. Process data will be collected throughout the study.

Participant Recruitment. A total of 546 mother-infant were recruited through community agencies providing services to pregnant women and mothers of infants in Michigan and Colorado (i.e., EFNEP, Breast Feeding Initiative, and Women, Infants and Children's Special Supplemental Nutrition Program for Women, Infants, and Children). Given each state's demographics, Michigan is has a higher proportion of Black minority dyads and Colorado a higher proportion of Hispanic/Latina dyads. Though race/ethnicity/culture is not a specific focus of the study, the sample size will allow us to examine race/ethnic/cultural similarities and differences.

The investigators have recruited of 546 eligible families in MI and CO which will allow for 25% attrition (at each data collection), leaving 278 families at post follow-up (when infant is 12 months old) available for data analysis.

연구 유형

중재적

등록 (실제)

546

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Colorado
      • Fort Collins, Colorado, 미국, 80523
        • Colorado State University
    • Michigan
      • East Lansing, Michigan, 미국, 48824
        • Michigan State University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Mothers aged 18 or older with one, two or three children
  • Infants of low-risk births aged birth to 4 months who have not been introduced to solid foods
  • Low income (those who qualify for EFNEP, income at or below 185% - 200% of the federal poverty level)
  • Infants born between 37 and 42 weeks gestational age with birth weight between 5 pounds 8 ounces and 8 pounds 13 ounces

Exclusion Criteria:

  • Male caregivers
  • Mothers and/or infants diagnosed with feeding or eating disorders

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Healthy Babies
Participants receive the Healthy Babies curriculum via 6 in home lessons and 3 follow up telephone calls delivered by Extension paraprofessionals.

Each lesson is designed to promote the development of healthy infant eating, and incorporates research-based information, opportunities for mothers to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques. During lessons, mothers engage in activities in support of lesson goals. Intervention strategies focusing on feeding practices will include modification of the feeding environment (e.g., television off during feeding).

The telephone contacts, 10 minutes in length, made at 6, 8, and 10 months, reinforce key concepts in the lessons after conclusion of the intervention to maintain effects.

활성 비교기: EFNEP
Participants receive the Expanded Food and Nutrition Education Program (EFNEP) curriculum via 6 in home lessons delivered by Extension paraprofessionals.
Core EFNEP concepts are United States Department of Agriculture (USDA) My Pyramid, fruits, vegetables, meats, whole grains, food safety, and food resource management. Educators for the EFNEP group will use the EFNEP lessons which address basic knowledge customized for families with infants. Mothers in the EFNEP group will receive a series of six lessons from the nutrition education program offered in each state; they provide a series of lessons focused on nutrition education for families and do not include extensive content on feeding infants.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)
기간: Change from Baseline in Maternal Responsiveness at 6 months
Change in maternal responsiveness is measured through an Observational measure (mother-infant feeding interaction): Maternal Responsiveness via Parent-Child Interaction-Feeding Scale (PCI-F) (Formerly Nursing Child Assessment of Feeding Scale)
Change from Baseline in Maternal Responsiveness at 6 months
Change in Baseline in Maternal Responsiveness at different time points (6 months and 12 months)
기간: Change in Baseline in Maternal Responsiveness at 12 months
Change in Baseline in maternal responsiveness at 12 months is measured via an observational tool: Parent-Child Interaction -Feeding Scale.
Change in Baseline in Maternal Responsiveness at 12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
기간: Change in Baseline in Feeding Practices at 6 months
Change in Feeding Practices is assessed via The Infant Feeding Scale (IFS)
Change in Baseline in Feeding Practices at 6 months
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
기간: Change in Baseline in feeding practices at 12 months
Change in Baseline in Feeding Practices at 12 months is assessed using the Infant Feeding Scale
Change in Baseline in feeding practices at 12 months

기타 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Feeding Styles assessed at different times (6 months and 12 months)
기간: Change in Baseline in Feeding Style at 6 months
Change from Baseline in Feeding Style at 6 months is assessed via the Infant Feeding Styles Questionnaire (IFSQ)
Change in Baseline in Feeding Style at 6 months
Change from Baseline in Infant Anthropometrics (infant weight and recumbent length) assessed at different time points (6 months and 12 months)
기간: Change in Baseline in infant weight and length in 6 months
Change from Baseline in Infant weight and recumbent length at 6 months measured using standardized Centers for Disease Control measurement protocol for in-home infant weight and recumbent length.
Change in Baseline in infant weight and length in 6 months
Change from Baseline in Feeding Style assessed at different time points (6 months and 12 months)
기간: Change in Baseline in Feeding Style at 12 months
Change from Baseline in Feeding Style at 12 months is assessed using the Infant Feeding Style Questionnaire.
Change in Baseline in Feeding Style at 12 months
Change from Baseline in infant anthropometrics (infant weight and recumbent length) assessed at different time points (6 months and 12 months)
기간: Change in Baseline in infant weight and recumbent length at 12 months
Change from Baseline in infant weight and recumbent length at 12 months is assessed using the standardized Centers for Disease Control in-home measurement protocol for infant weight and recumbent length.
Change in Baseline in infant weight and recumbent length at 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mildred Horodynski, PhD, RN, Michigan State University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 2월 1일

기본 완료 (실제)

2014년 2월 1일

연구 완료 (실제)

2014년 2월 1일

연구 등록 날짜

최초 제출

2013년 3월 18일

QC 기준을 충족하는 최초 제출

2013년 3월 19일

처음 게시됨 (추정)

2013년 3월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 5월 30일

마지막으로 확인됨

2014년 5월 1일

추가 정보

이 연구와 관련된 용어

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. .

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