Clinical trial NCT03529695: In-home Obesity Prevention to Reach Low-income Infants
Official title: In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obesity, Childhood
Obesity; Familial
Keywords: obesity
childhood obesity
maternal and child health
health disparities
prevention
low-income
social network
home environment
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Antelope Valley Partners for Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Cedars-Sinai Medical Center
First posted: 2018-05-18
Enrollment: 77
Sex: FEMALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomization occurs at the level of home visitors who deliver the home visitation program curriculum. Home visitors will be randomized to deliver the home visitation program curriculum with (Experimental comparator) or without (Active Comparator) the obesity prevention enhancement module. Mother-child dyads enrolled in home visitation programs, and who agree to participate in the study, will receive the intervention arm delivered by their home visitor.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: \*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

Primary outcomes:
measure: Mother BMI
timeFrame: Baseline, 6 months, 12 months
measure: Infant Weight
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Fruit Intake Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Vegetable Intake Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Fried Food Intake Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Soda Intake Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Fruit Juice Intake Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Mother Movement Frequency
timeFrame: Baseline, 6 months, 12 months
measure: Frequency of Infant Supervised Active Movement (Activity)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Maternal Food Security
timeFrame: Baseline, 6 months, 12 months
measure: Maternal Social Isolation
timeFrame: Baseline, 6 months, 12 months
measure: Maternal Instrumental Support
timeFrame: Baseline, 6 months, 12 months
measure: Maternal Emotional Support
timeFrame: Baseline, 6 months, 12 months
measure: Social Network Health Norms
timeFrame: Baseline, 6 months, 12 months
measure: Social Network Support
timeFrame: Baseline, 6 months, 12 months
measure: Household Activity Environment
timeFrame: Baseline, 6 months, 12 months
measure: Household Food Environment
timeFrame: Baseline, 6 months, 12 months
measure: Habit Strength of Maternal Eating, Activity, and Feeding Behaviors
timeFrame: Baseline, 6 months, 12 months
measure: Demographic History
timeFrame: Baseline
measure: Medical History
timeFrame: Baseline, 6 months, 12 months
measure: Depression
timeFrame: Baseline, 6 months, 12 months
measure: Mother's Blood Pressure
timeFrame: Baseline, 12 months
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Kayla de la Haye, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Sarah-Jeanne Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.