跳至主要内容
临床试验/NCT06051591
NCT06051591招募中不适用

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Stanford University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Recruitment feasibility

研究概览

简要总结

The goal of this clinical trial is to test whether the Food FARMacia intervention to reduce food insecurity is feasible and accepted among families with an infant age 6 to less than 18 months receiving pediatric primary care.

All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

详细描述

Childhood obesity remains highly prevalent and originates early in life. Efficacious early life interventions to prevent childhood obesity are lacking, particularly among populations most burdened by childhood obesity. Food insecurity - defined as lack of enough food for an active, healthy life - may play key upstream roles in etiologies of obesity through establishment of unhealthy dietary patterns and stress-related metabolic perturbations. Household food insecurity during the first 24 months of life is a risk factor for later childhood obesity. Professional organizations recommend integration of household food insecurity screening into routine pediatric primary care. Yet, a critical gap exists in identification of efficacious clinical interventions to reduce food insecurity. Another gap exists in understanding relationships between food insecurity and etiologies of obesity. Food FARMacia is a clinically based mobile food pantry intervention developed to address the high prevalence of food insecurity among pediatric patients. No randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist. To understand the role of food insecurity in etiologies of childhood obesity, efficacious interventions to reduce food insecurity are needed.

Household food insecurity during infancy is a risk factor for later childhood obesity. In this pilot and feasibility study, the investigators will randomly assign infants and their parent in households with food insecurity to either 1) the Food FARMacia mobile food pantry intervention with twice monthly food distributions and self-directed meal preparation support or 2) self-directed meal preparation support. Infants age 6 to <18 months who are patients at Stanford University/Stanford Health Care who screen positive for food insecurity will potentially be eligible participants for recruitment. Parents will be asked to respond to survey questions about health behaviors for themself and their infant at baseline and follow-up.

The investigators will measure vital signs (e.g., weight and height/length) for parents and infants at baseline and follow-up. The investigators will examine feasibility, acceptability, and satisfaction with the study procedures and intervention materials. The investigators will estimate intervention effects on infant weight characteristics and explore potential mediators such as reduction in food insecurity and changes in nutrition and other established obesity risk factors to inform a subsequent full-scale trial. If successful, results will lead to a full-scale trial to test effects of the intervention on food insecurity, nutrition, and infant growth. Eventually, these study results could transform clinical care to reduce childhood obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants will not be masked as they will be receiving twice monthly groceries if they are enrolled in the Food FARMacia program.

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 6 to < 18 months at enrollment
  • Born gestational age 37 weeks or later without evidence of undernutrition at routine health care visits
  • In household with food insecurity at time of screening phone call based on an affirmative response on the 2-item Hunger Vital Signs™ screening tool
  • Primary pediatric care patient at Stanford University/Stanford Health Care Network
  • Planned continuation of primary pediatric care at Stanford University/Stanford Health Care
  • Living in a community setting (not inpatient or living in a nursing/long-term care setting) with a caretaker enrolled in this study

排除标准

  • Gestational age < 37 weeks
  • Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)
  • Weight-for-length < 3rd percentile
  • Body Mass Index < 5th percentile for age and sex
  • Children in household previously enrolled in this study or the Food FARMacia program
  • Conditions that substantially interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)
  • Children with special diets (e.g., tyrosinemia, enteral tube feeding)
  • Children with chronic diseases that interfere with nutrition and growth as determined by investigators
  • Inclusion Criteria for Parent/Legal Guardian:
  • Primary caretaker of infant eligible for study and with planned enrollment in this study
  • Age 18 years or older
  • Ability to respond to questions in English and/or Spanish
  • Willing for self and infant to be randomized into a RCT and complete all study components
  • Gives permission to receive messages to their mobile device, email, and or place of residence
  • Gives permission to complete all study procedures for self and infant
  • Capable of providing informed consent for self and infant
  • Exclusion Criteria for Parent/Legal Guardian:
  • Pregnancy at baseline visit because of unique nutritional needs
  • Age < 18 years at baseline because of unique developmental differences of adolescents and New York State regulations
  • Inability to complete study visits or intervention components
  • Unwillingness or inability to commit to a 6-month research study for self or infant
  • Unable to give informed consent
  • Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)

研究组 & 干预措施

Attention Control

Active Comparator

Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

干预措施: Self-directed meal preparation support (Behavioral)

Food FARMacia intervention

Experimental

Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation.

干预措施: Food FARMacia Program (Behavioral)

Food FARMacia intervention

Experimental

Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation.

干预措施: Self-directed meal preparation support (Behavioral)

结局指标

主要结局

Recruitment feasibility

时间窗: 24 months

Completion of enrollment of 80 households within the study timeframe

Retention Rate

时间窗: 6 months

At least 70% with complete follow-up visits at 6-month follow-up

Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm

时间窗: 6 months

At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up

Intervention Satisfaction - Intervention Arm

时间窗: 6 months

Average report of agree or strongly agree (mean score 4 or higher on a 5-point scale) with intervention satisfaction at 6-month follow-up

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

Jennifer Woo Baidal

Associate Professor of Pediatrics

Stanford University

研究点 (2)

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