Overview

This trial is active, not recruiting.

Condition obesity
Treatments parents as teachers enhanced, parents as teachers
Sponsor USDA, Delta Human Nutrition Research Program
Start date January 2013
End date July 2016
Trial size 150 participants
Trial identifier NCT01746394, DHN_12_01

Summary

The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150 African American women in their early second trimester of pregnancy. The control arm, Parents as Teachers, is an evidence-based approach to increase parental knowledge of child development and improve parenting practices. The experimental arm, Parents as Teachers Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical activity components specifically designed for the gestational and postnatal periods. Both arms of the intervention will be implemented by community-based, trained Parent Educators. The comparative effectiveness of the two intervention arms on weight status, dietary intake, and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts Project will determine if a novel, scalable, lifestyle intervention can improve the health of African American women and their children at high-risk for obesity and chronic disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants in the Parents as Teachers Enhanced (PaTE) intervention arm will receive the enhanced diet and activity maternal, infant, and early childhood home visiting program
parents as teachers enhanced PaTE
Participants will receive the same monthly Parents as Teachers (PaT) lessons and materials at each home visit as the PaT arm. Additionally, these mothers will receive the enhanced nutrition and physical activity lessons and materials which will follow the family well-being format of the PaT lessons. The StartSmart lessons will focus on healthy gestational weight gain, diet, physical activity, breastfeeding, weight management, healthy eating, food shopping, meal preparation, physical activity, proper infant feeding, and infant activity time.
parents as teachers PaT
Participants will receive monthly Parents as Teachers (PaT) lessons and materials at each home visit. The Parent Educator will first connect with the mother by discussing or reviewing content from the prior visit; reflect on the mother's experience with continuing the parent-child activity from the prior visit; and agree on what will happen during the current visit. For the lesson plan, the Parent Educator will cover the following three areas using discussion, activities, and handouts: parent-child interaction, develop-centered parenting, and family well-being. In closing, the Parent Educator will review and evaluate the visit, talk about the mother's next step, and plan for the next visit.
(Active Comparator)
Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program
parents as teachers PaT
Participants will receive monthly Parents as Teachers (PaT) lessons and materials at each home visit. The Parent Educator will first connect with the mother by discussing or reviewing content from the prior visit; reflect on the mother's experience with continuing the parent-child activity from the prior visit; and agree on what will happen during the current visit. For the lesson plan, the Parent Educator will cover the following three areas using discussion, activities, and handouts: parent-child interaction, develop-centered parenting, and family well-being. In closing, the Parent Educator will review and evaluate the visit, talk about the mother's next step, and plan for the next visit.

Primary Outcomes

Measure
Gestational weight gain
time frame: 9 months gestation
Maternal postpartum weight retention
time frame: 12 months postnatal
Maternal dietary intake
time frame: 12 months postpartum
Maternal physical activity
time frame: 12 months postpartum
Infant dietary intake
time frame: 12 months after birth
Infant activity
time frame: 12 months after birth
Infant body mass index
time frame: 12 months after birth

Secondary Outcomes

Measure
Breastfeeding
time frame: 12 months postpartum
Home food environment
time frame: 12 months postpartum

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - At least 18 years of age - Less than 18 weeks pregnant with first, second, or third child - Resident of Mississippi counties of Washington and Bolivar Exclusion Criteria: - Pregnant with more than one fetus

Additional Information

Official title Delta Healthy Sprouts: A Randomized Trial to Determine the Comparative Efficacy of Two Maternal, Infant, and Early Childhood Home Visiting Programs on Maternal Weight Control and Childhood Obesity in the Mississippi Delta
Principal investigator Jessica L Thomson, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by USDA, Delta Human Nutrition Research Program.