Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta

NCT ID: NCT01746394

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Parents as Teachers Enhanced

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Parents as Teachers

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

Group Type ACTIVE_COMPARATOR

Parents as Teachers

Intervention Type BEHAVIORAL

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.

Interventions

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Parents as Teachers Enhanced

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.

Intervention Type BEHAVIORAL

Parents as Teachers

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PaTE PaT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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USDA, Delta Human Nutrition Research Program

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica L Thomson, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Agricultural Research Service

Lisa M Tussing-Humphreys, PhD

Role: STUDY_CHAIR

University of Illinois at Chicago

Locations

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USDA Agricultural Research Service Mid South Area Office

Stoneville, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24685997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29785275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29396153 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29214042 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28405211 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27779937 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27595023 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27536380 (View on PubMed)

Other Identifiers

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DHN_12_01

Identifier Type: -

Identifier Source: org_study_id

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