In-home Obesity Prevention to Reach Low-income Infants

NCT03529695 | Completed Results DMC

• 1 other identifier: 1R01HD092483-01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obesity, Childhood; Obesity; Familial

Keywords

obesity; childhood obesity; maternal and child health; health disparities; prevention; low-income; social network; home environment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Fruit Intake Frequency

  Baseline, 6 months, 12 months

• Vegetable Intake Frequency

  Baseline, 6 months, 12 months

• Fried Food Intake Frequency

  Baseline, 6 months, 12 months

• Soda Intake Frequency

  Baseline, 6 months, 12 months

• Fruit Juice Intake Frequency

  Baseline, 6 months, 12 months

Other Outcomes (13)

• Maternal Food Security

  Baseline, 6 months, 12 months

• Maternal Social Isolation

  Baseline, 6 months, 12 months

• Maternal Instrumental Support

  Baseline, 6 months, 12 months

Study Arms (2)

Standard HVP Curriculum

ACTIVE COMPARATOR

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

Obesity Prevention

EXPERIMENTAL

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; Behavioral: Obesity Prevention

Interventions

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; Standard HVP Curriculum

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.

Obesity Prevention

Eligibility Criteria

• Age: 2 Months+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• months of age at time of enrollment
• Parent or primary caregiver receiving home visitation services

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Southern California

Los Angeles, California, 90089-9239, United States

Location

Related Publications (1)

• 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.

  PMID: 30578850 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kayla De La Haye, PhD, Research Scientist
• Organization: USC Center for Economic and Social Research

delahaye@usc.edu

323-442-8228

Study Officials

• Kayla de la Haye, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Sarah-Jeanne Salvy, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 18, 2018
• Study Start: November 1, 2018
• Primary Completion: January 30, 2023
• Study Completion: May 31, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.

Locations

US (1)