Healthy Eating for My Infant: A Community- Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding

Официальное название

Feasibility, Acceptability, and Preliminary Phase II Efficacy Testing of a Community-Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding.

Обзор

Infants from low-income families are at increased risk for obesity, but obesity prevention programs tailored specifically to the needs of these infants are lacking. Our team developed Healthy Eating for My Infant (HEMI) to address the specific obesity risk factors, barriers to health behaviors, and needs articulated by community members and low-income families (e.g., maternal mental health, realistic feeding options within the context of food insecurity). The current study will examine the feasibility and acceptability of HEMI delivered via home visiting, as well as preliminary efficacy for improving infant growth trajectories, diet, and parenting/feeding factors related to future obesity risk among infants from low-income families.

Вмешательства

• Поведенческое Healthy Eating for My Infant (HEMI)
  Our team developed an obesity prevention program, Healthy Eating for My Infant (HEMI), to address the unique factors influencing obesity risk and health behaviors among low-income families and their infants and to be delivered in conjunction with an existing evidence-based home visiting program. HEMI targets healthy feeding with children 3-14 months old through twice monthly behavioral and educational sessions alongside sessions with a peer counselor with similar lived experience to mothers in t

Первичные конечные точки

• Participant Retention [Срок оценки: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit)]
• Treatment Session Completion [Срок оценки: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program).]
• Treatment Acceptability [Срок оценки: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit)]
• Body Mass Index [Срок оценки: Between child ages 3-14 months (when the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).]
• Diet Variety [Срок оценки: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).]
• Diet Quality [Срок оценки: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).]
• Food Security [Срок оценки: Baseline, immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).]

Критерии участия

Критерии включения

• Child age 2 months 0 days to 2 months 30 days at baseline.
• Child is a singleton.
• Mom's must be fluent in English or Spanish.
• Mom must be 18 years or older.

Критерии исключения

• Child has major congenital abnormalities or medical conditions requiring specialized feeding.
• Family is currently enrolled in home grocery delivery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Cincinnati — Cincinnati

Идентификаторы

NCT: NCT07284108 · 1R01DK142998-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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