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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Maternal dietary intake
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Parents as Teachers Enhanced
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
Intervention: Parents as Teachers Enhanced (Behavioral)
Parents as Teachers Enhanced
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
Intervention: Parents as Teachers (Behavioral)
Parents as Teachers
Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program
Intervention: Parents as Teachers (Behavioral)
Outcomes
Primary Outcomes
Maternal dietary intake
Time Frame: 12 months postpartum
Dietary intake measured using 24-hour dietary recall
Infant activity
Time Frame: 12 months after birth
Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)
Infant body mass index
Time Frame: 12 months after birth
Incremental body mass index during the first year of life
Maternal postpartum weight retention
Time Frame: 12 months postnatal
Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight
Maternal physical activity
Time Frame: 12 months postpartum
Physical activity measured using a physical activity questionnaire
Gestational weight gain
Time Frame: 9 months gestation
Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)
Infant dietary intake
Time Frame: 12 months after birth
Dietary intake measured using 24-hour dietary recall as reported by mother
Secondary Outcomes
- Breastfeeding(12 months postpartum)
- Home food environment(12 months postpartum)