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临床试验/NCT07284108
NCT07284108Enrolling By Invitation不适用

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.

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Participant Retention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Months 至 21 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Control

No Intervention

Participants randomized into this arm will not receive the study intervention. They will continue to receive standard home visiting services through Every Child Succeeds.

Intervention

Experimental

Participants randomized into this arm will receive the Healthy Eating for My Infant Intervention (HEMI).

干预措施: Healthy Eating for My Infant (HEMI) (Behavioral)

结局指标

主要结局

Participant Retention

时间窗: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit)

Participant retention is defined as the percentage of participants that complete each study visit. The percentage of participants completing the post-treatment measurement visit and the 6-month follow-up visit will be calculated, and separate percentages will be calculated for each arm of the study (i.e., control, intervention). This will be measured by tracking yes or no for whether each study visit is completed for each participant.

Treatment Session Completion

时间窗: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program).

The percentage of treatment sessions completed within the designated completion windows will be monitored.

Treatment Acceptability

时间窗: 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)

Families, peer counselors, and health behavior coaches delivering the program will evaluate program acceptability, utilizing the theoretical framework of acceptability. Families will complete an established questionnaire assessing components of the TFA: affective attitude and effectiveness, coherence and understanding, and perceived burden. The established questionnaire will also be modified to be completed by peer counselors and health behavior coaches to report their perception of acceptability of the program for families. Qualitative interviews will also be conducted with families, peer counselors, and health behavior coaches to identify any modifications to the HEMI program to improve acceptability.

Body Mass Index

时间窗: 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).

Anthropometrics will be measured in triplicate using a calibrated mobile digital SECA baby scale and portable infant length board. Infants will be weighed in a clean diaper without clothes to the nearest 1 gram. The length board has a stable headboard and a moveable foot piece and will be placed on a flat, hard surface. All length measurements will be performed by two team members, with one holding the infant's head straight and flush against the headboard, while the other places one hand across the knees to fully straighten and extend the legs so that heels are at a 90-degree angle against the foot piece and reads the measurement. If holding both legs is not possible, the measurement can be taken with only the right leg extended.

Diet Variety

时间窗: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).

Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. Data from dietary recalls will be used to calculate diet variety using the minimum dietary diversity (MDD) approach.

Diet Quality

时间窗: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).

Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. The Nutrition Data Systems for Research (NDSR; Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess total daily energy and macronutrient intake as well as food group servings consumed. Data from dietary recalls will be used to calculate diet quality using the Healthy Eating Index (HEI-Toddlers-2020) for children under age 2 years.

Food Security

时间窗: Baseline, 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 will be reported using the U.S. Household Food Security Survey Module: Short Form.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cathy Stough

Associate Professor

University of Cincinnati

研究点 (1)

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