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Healthy Babies Through Infant Centered Feeding (HB)

30 maggio 2014 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

546

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Feeding Styles assessed at different times (6 months and 12 months)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mildred Horodynski, PhD, RN, Michigan State University

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2010

Completamento primario (Effettivo)

1 febbraio 2014

Completamento dello studio (Effettivo)

1 febbraio 2014

Date di iscrizione allo studio

Primo inviato

18 marzo 2013

Primo inviato che soddisfa i criteri di controllo qualità

19 marzo 2013

Primo Inserito (Stima)

22 marzo 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 giugno 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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