In-home Obesity Prevention to Reach Low-income Infants

In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission

Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and their infants, to test the effectiveness of delivering obesity prevention as part of their weekly, in-home services. The study will evaluate whether the integration of an obesity prevention enhancement module into existing HVP services, reduces the risk and incidence of obesity and associated risk factors in mothers and infants, compared to the provision of standard home visitation services. The study also focuses on the role of maternal factors (maternal diet, physical activity, food insecurity and feeding practices) and social factors (social network support) as mechanisms operating on infant outcomes.

Study Overview

• Status: Completed
• Conditions: Obesity; Obesity, Childhood; Obesity; Familial
• Intervention / Treatment: Behavioral: Standard HVP Curriculum; Behavioral: Obesity Prevention

Detailed Description

More than 40% of children enrolled in federally funded programs are overweight or obese by age 5. Unfortunately, extant obesity efforts have had a limited impact among low-income underserved children, in part because of limitations inherent to existing programs: 1) short duration and low intensity; 2) late timing of implementation, when children are already overweight or obese; 3) delivery methods limiting their accessibility and sustainability; and 4) failure to address barriers such as a lack of culturally competent services, poverty, housing instability, and access to care, which interfere with healthy lifestyle changes. To address these gaps, we have integrated simple, evidence-based nutrition and physical activity components as part of the services already delivered by our home visitation partner, Healthy Families America, with the long-term goal to deploy these efforts to Home Visitation Programs (HVPs) nationwide. Annually, over 500 publicly and privately funded HVPs provide nationwide services to more than 650,000 low-income, underserved infants and their families. The home visiting structure is not only an unparalleled model for scalable and sustainable childhood obesity prevention, but it also provides a unique opportunity to understand factors related to the intergenerational transmission of obesity in families who are most at risk.

Over the last four years, our transdisciplinary team of researchers, home visiting stakeholders, families, and community stakeholders has integrated evidence-based nutrition and physical activity components into an engaging obesity prevention curriculum delivered in English and Spanish as an enhancement module to the services of our HVP partner. Our pilot work supports the successful integration, feasibility, and preliminary efficacy of integrating obesity prevention as part of HVP services. The proposed study tests the large-scale and sustained impact of home-based obesity prevention on infant's and mothers' obesity outcomes, and studies key mechanisms of maternal and social transmission on infants' obesity risk.

Specifically, 300 low-income mothers/infants enrolled in Healthy Families America's HVP will be recruited and enrolled in the study. Based on standard HVP procedures, mothers/infants will be matched to highly trained home visitors based on their ethnicity/race and language preferences. Home visitors, in turn, will be randomly assigned to deliver the standard HVP curriculum only or the standard HVP curriculum + obesity prevention as part of their weekly home visits, for the first 12 months of HVP services. Comprehensive assessments of mothers/infants will be conducted at enrollment and after 6 and 12 months of intervention.

Aim 1 (maternal and infant outcomes). Test the direct effects of obesity prevention on infants and mothers' weight, metabolic risks, diet/energy intake, and physical activity. This will be accomplished by comparing changes in body weight, metabolic markers, and eating and activity-related behaviors between infants/mothers across study arms (HVP only vs. HVP+obesity prevention). These results will indicate whether HVP is an effective infrastructure for primary and secondary obesity prevention.

Aim 2 (maternal transmission). Test whether breastfeeding and maternal diet and activity, feeding practices, and food insecurity mediate the effect of obesity prevention on infants' outcomes. This aim will test mechanisms of maternal transmission on infants' obesity risks.

Aim 3 (social transmission). Aim 3 is two-pronged. Aim 3a tests the direct effect of HVP+obesity prevention (vs. HVP only) on the characteristics of the social and community networks that surround mothers and infants (i.e., the density, composition, and quality of health support networks). Aim 3b tests whether the characteristics of social networks mediate the effects of obesity prevention on maternal and infant outcomes. These findings will indicate if the delivery of in-home obesity prevention efforts can alter and/or activate social network mechanisms.

Secondary Aim. Conduct a real-life economic analysis (costs, cost-savings, and non-monetary benefits) of integrating obesity prevention into existing HVPs.

This proposal addresses the impetus to develop interventions targeting at-risk infants before obesity is established. Although maternal-infant interventions are much-needed, they present implementation and dissemination challenges, including limitations on compliance and retention, and limited potential for scalability and sustainability. Our proposed strategy overcomes these challenges through an innovative solution that merges evidence-based nutrition and activity components into an existing, ongoing federally-funded infrastructure. The proposed research is timely as the Institute of Medicine, the United States Department of Agriculture, and Health and Human Services (DHHS) extend their recommendations to address key factors influencing obesity risk in children from birth to 24 months of age.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089-9239
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.

Inclusion Criteria:

Mothers:

• Enrolled in a partnered home visitation program
• Mother or primary caregiver of 2-8 month old child
• BMI above 18.5
• Generally Healthy

Children:

• 2-8 months of age at time of enrollment
• Parent or primary caregiver receiving home visitation services

Exclusion Criteria:

Mothers:

• Any history of an eating or feeding disorder, or obesity related syndrome (such as Prader-Willi)
• Diagnosis of Schizophrenia
• Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.

Infants:

• Infant is clinically underweight (<5th percentile) or has a history of a feeding or eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard HVP Curriculum; Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.	Behavioral: Standard HVP Curriculum; Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Experimental: Obesity Prevention; Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.	Behavioral: Standard HVP Curriculum; Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.; Behavioral: Obesity Prevention; Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother BMI	Body mass index (BMI) at each assessment	Baseline, 6 months, 12 months
Infant Weight	weight in pounds	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit Intake Frequency	Assessed using modified food frequency measures from the National Health and Nutrition Examination Survey (NHANES).	Baseline, 6 months, 12 months
Vegetable Intake Frequency	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months
Fried Food Intake Frequency	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months
Soda Intake Frequency	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months
Fruit Juice Intake Frequency	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months
Mother Movement Frequency	Assessed using modified activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months
Frequency of Infant Supervised Active Movement (Activity)	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)	Baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Food Security	The U.S. Adult Food Security Survey Module will be used to evaluate hunger and food sufficiency to meet the basic needs of families.	Baseline, 6 months, 12 months
Demographic History	Self-reported demographic history (gender, age, race, household income, etc) will be collected. Acculturation is measured using the Demographic Index of Cultural Exposure (DICE).	Baseline
Medical History	Self-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected	Baseline, 6 months, 12 months
Depression	The Edinburgh Postnatal Depression Scale (EPDS) will be used to determine maternal depression. Each of the 10 items has 4 optional responses with a set coding frame. Scores are summed and can range from 0 to 30. Values over 11 are indicative of risk for postnatal depression.	Baseline, 6 months, 12 months
Mother's Blood Pressure	Blood pressure will be collected prior to all blood draws	Baseline, 12 months
Maternal Social Isolation	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation.	Baseline, 6 months, 12 months
Maternal Instrumental Support	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support.	Baseline, 6 months, 12 months
Maternal Emotional Support	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support.	Baseline, 6 months, 12 months
Social Network Health Norms	The characteristics of the social actors (people) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the health behavior and weight norms.	Baseline, 6 months, 12 months
Social Network Support	The characteristics of the social actors (people, organizations) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the density of relationships that provide health-related social support.	Baseline, 6 months, 12 months
Household Activity Environment	Household environment assessing availability, accessibility, and visibility of activity items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target activity behaviors.	Baseline, 6 months, 12 months
Household Food Environment	Household environment assessing availability, accessibility, and visibility of food items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target eating behaviors.	Baseline, 6 months, 12 months
Habit Strength of Maternal Eating, Activity, and Feeding Behaviors	Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target eating and activity behaviors.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Cedars-Sinai Medical Center; Antelope Valley Partners for Health
• Investigators: Principal Investigator: Kayla de la Haye, PhD, University of Southern California; Principal Investigator: Sarah-Jeanne Salvy, PhD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• de la Haye K, Fluke M, Laney PC, Goran M, Galama T, Chou CP, Salvy SJ. In-home obesity prevention in low-income infants through maternal and social transmission. Contemp Clin Trials. 2019 Feb;77:61-69. doi: 10.1016/j.cct.2018.12.010. Epub 2018 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: obesity; childhood obesity; prevention; maternal and child health; health disparities; home environment; social network; low-income
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 1R01HD092483-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Development, execution, and data collection for this study is completed with a Principle Investigator at Cedars-Sinai Medical Center. Data will be shared with Dr. Salvy and her staff as appropriate. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No