In-home Obesity Prevention to Reach Low-income Infants

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529695
• Other study ID #: 1R01HD092483-01
• Secondary ID: 1R01HD092483-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 31, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 2 Months and older

Eligibility

*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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Obesity; Familial
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Antelope Valley Partners for Health, Cedars-Sinai Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Medical History	Self-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected	Baseline, 6 months, 12 months
Other	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
Other	Mother's Blood Pressure	Blood pressure will be collected prior to all blood draws	Baseline, 12 months
Other	Mother height and infant length	Mother height and infant length in inches will be measured by trained assessment workers. This will be combined with measures of mother and infant weight to compute body mass index (BMI) for mothers (kg/m^2); and infant weight-for-length based on World Health Organization (WHO) standards.	Baseline, 6 months, 12 months
Primary	BMI of mothers	BMI at each assessment.	Baseline, 6 months, 12 months
Primary	Weight of infants	weight in pounds at each assessments	Baseline, 6 months, 12 months
Secondary	Maternal eating, feeding, and activity behaviors	Assessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES), amended to measure target eating and feeding habits of the mother.	Baseline, 6 months, 12 months
Secondary	Infant eating and activity behaviors	Assessed using modified food and activity frequency measure from NHANES, as reported by the mother, and amended to measure target eating and activity.	Baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal emotional support	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support.	Baseline, 6 months, 12 months
Secondary	Maternal instrumental support	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support.	Baseline, 6 months, 12 months
Secondary	Maternal social isolation	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation.	Baseline, 6 months, 12 months
Secondary	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