NCT01746394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

December 5, 2012

Last Update Submit

October 24, 2016

Conditions

Obesity

Keywords

obesitypregnant womennutrition assessmenthealth behavior

Outcome Measures

Primary Outcomes (7)

  • Gestational weight gain

    Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)

    9 months gestation

  • Maternal postpartum weight retention

    Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight

    12 months postnatal

  • Maternal dietary intake

    Dietary intake measured using 24-hour dietary recall

    12 months postpartum

  • Maternal physical activity

    Physical activity measured using a physical activity questionnaire

    12 months postpartum

  • Infant dietary intake

    Dietary intake measured using 24-hour dietary recall as reported by mother

    12 months after birth

  • Infant activity

    Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)

    12 months after birth

  • Infant body mass index

    Incremental body mass index during the first year of life

    12 months after birth

Secondary Outcomes (2)

  • Breastfeeding

    12 months postpartum

  • Home food environment

    12 months postpartum

Study Arms (2)

Parents as Teachers Enhanced

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

Behavioral: Parents as Teachers EnhancedBehavioral: Parents as Teachers

Parents as Teachers

ACTIVE COMPARATOR

Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program

Behavioral: Parents as Teachers

Interventions

Parents as Teachers EnhancedBEHAVIORAL

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.

Also known as: PaTE
Parents as Teachers Enhanced
Parents as TeachersBEHAVIORAL

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.

Also known as: PaT
Parents as TeachersParents as Teachers Enhanced

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant with more than one fetus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Agricultural Research Service Mid South Area Office

Stoneville, Mississippi, 38776, United States

Location

Related Publications (8)

  • Thomson JL, Tussing-Humphreys LM, Goodman MH. Delta Healthy Sprouts: a randomized comparative effectiveness trial to promote maternal weight control and reduce childhood obesity in the Mississippi Delta. Contemp Clin Trials. 2014 May;38(1):82-91. doi: 10.1016/j.cct.2014.03.004. Epub 2014 Mar 29.

    PMID: 24685997BACKGROUND

  • Thomson JL, Tussing-Humphreys LM, Goodman MH, Landry AS. Infant activity and sleep behaviors in a maternal and infant home visiting project among rural, southern, African American women. Matern Health Neonatol Perinatol. 2018 May 16;4:10. doi: 10.1186/s40748-018-0078-0. eCollection 2018.

    PMID: 29785275DERIVED

  • Thomson JL, Tussing-Humphreys LM, Landry AS, Goodman MH. No Improvements in Postnatal Dietary Outcomes Were Observed in a Two-Arm, Randomized, Controlled, Comparative Impact Trial among Rural, Southern, African-American Women. J Acad Nutr Diet. 2018 Jul;118(7):1196-1207. doi: 10.1016/j.jand.2017.11.010. Epub 2018 Feb 1.

    PMID: 29396153DERIVED

  • Tussing-Humphreys LM, Thomson JL, Hemphill NO, Goodman MH, Landry AS. Maternal weight in the postpartum: results from the Delta healthy sprouts trial. Matern Health Neonatol Perinatol. 2017 Dec 4;3:20. doi: 10.1186/s40748-017-0058-9. eCollection 2017.

    PMID: 29214042DERIVED

  • Thomson JL, Tussing-Humphreys LM, Goodman MH, Landry AS, Olender SE. Low rate of initiation and short duration of breastfeeding in a maternal and infant home visiting project targeting rural, Southern, African American women. Int Breastfeed J. 2017 Apr 8;12:15. doi: 10.1186/s13006-017-0108-y. eCollection 2016.

    PMID: 28405211DERIVED

  • Thomson JL, Tussing-Humphreys LM, Goodman MH, Olender SE. Physical Activity Changes during Pregnancy in a Comparative Impact Trial. Am J Health Behav. 2016 Nov;40(6):685-696. doi: 10.5993/AJHB.40.6.1.

    PMID: 27779937DERIVED

  • Thomson JL, Tussing-Humphreys LM, Goodman MH, Olender SE. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial. J Pregnancy. 2016;2016:5703607. doi: 10.1155/2016/5703607. Epub 2016 Aug 9.

    PMID: 27595023DERIVED

  • Tussing-Humphreys LM, Thomson JL, Goodman MH, Olender S. Maternal diet quality and nutrient intake in the gestational period: results from the delta healthy sprouts comparative impact trial. Matern Health Neonatol Perinatol. 2016 Aug 17;2:8. doi: 10.1186/s40748-016-0036-7. eCollection 2016.

    PMID: 27536380DERIVED

MeSH Terms

Conditions

ObesityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jessica L Thomson, PhD

    USDA Agricultural Research Service

    PRINCIPAL INVESTIGATOR

  • Lisa M Tussing-Humphreys, PhD

    University of Illinois at Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-02

Locations

US(1)