Skip to main content
OpenTrials
Completed

NCT Number: NCT03529695

In-home Obesity Prevention to Reach Low-income Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 month and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089-9239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

*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

Treatment and study plan

Standard HVP Curriculum

Behavioral

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.

Obesity Prevention

Behavioral

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.

Primary outcomes

  1. Mother BMI

    Time frame: Baseline, 6 months, 12 months

    Body mass index (BMI) at each assessment

  2. Infant Weight

    Time frame: Baseline, 6 months, 12 months

    weight in pounds

Secondary outcomes

  1. Fruit Intake Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food frequency measures from the National Health and Nutrition Examination Survey (NHANES).

  2. Vegetable Intake Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

  3. Fried Food Intake Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

  4. Soda Intake Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

  5. Fruit Juice Intake Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

  6. Mother Movement Frequency

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

  7. Frequency of Infant Supervised Active Movement (Activity)

    Time frame: Baseline, 6 months, 12 months

    Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)

Other outcomes

  1. Maternal Food Security

    Time frame: Baseline, 6 months, 12 months

    The U.S. Adult Food Security Survey Module will be used to evaluate hunger and food sufficiency to meet the basic needs of families.

  2. Maternal Social Isolation

    Time frame: Baseline, 6 months, 12 months

    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation.

  3. Maternal Instrumental Support

    Time frame: Baseline, 6 months, 12 months

    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support.

  4. Maternal Emotional Support

    Time frame: Baseline, 6 months, 12 months

    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support.

  5. Social Network Health Norms

    Time frame: Baseline, 6 months, 12 months

    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.

  6. Social Network Support

    Time frame: Baseline, 6 months, 12 months

    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.

  7. Household Activity Environment

    Time frame: Baseline, 6 months, 12 months

    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.

  8. Household Food Environment

    Time frame: Baseline, 6 months, 12 months

    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.

  9. Habit Strength of Maternal Eating, Activity, and Feeding Behaviors

    Time frame: Baseline, 6 months, 12 months

    Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target eating and activity behaviors.

  10. Demographic History

    Time frame: Baseline

    Self-reported demographic history (gender, age, race, household income, etc) will be collected. Acculturation is measured using the Demographic Index of Cultural Exposure (DICE).

  11. Medical History

    Time frame: Baseline, 6 months, 12 months

    Self-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected

  12. Depression

    Time frame: Baseline, 6 months, 12 months

    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.

  13. Mother's Blood Pressure

    Time frame: Baseline, 12 months

    Blood pressure will be collected prior to all blood draws

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Antelope Valley Partners for Health
  • Cedars-Sinai Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 18, 2018
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.