Delta Healthy Sprouts: A Randomized Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the Mississippi Delta - Full Text View

Purpose

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.

Condition	Intervention
Obesity	Behavioral: Parents as Teachers Enhanced Behavioral: Parents as Teachers

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Healthy Living Obesity

U.S. FDA Resources

Further study details as provided by USDA, Delta Human Nutrition Research Program:

Primary Outcome Measures:

Gestational weight gain [ Time Frame: 9 months gestation ] [ Designated as safety issue: No ]
Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)
Maternal postpartum weight retention [ Time Frame: 12 months postnatal ] [ Designated as safety issue: No ]
Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight
Maternal dietary intake [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Dietary intake measured using 24-hour dietary recall
Maternal physical activity [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Physical activity measured using a physical activity questionnaire
Infant dietary intake [ Time Frame: 12 months after birth ] [ Designated as safety issue: No ]
Dietary intake measured using 24-hour dietary recall as reported by mother
Infant activity [ Time Frame: 12 months after birth ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Incremental body mass index during the first year of life

Secondary Outcome Measures:

Breastfeeding [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Breastfeeding initiation and continuation for first 12 months after birth of infant
Home food environment [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Measured using home food inventory; based on direct observation of foods in household (i.e. in refrigerator, freezer, pantry, cupboards, or other areas food is stored)

Estimated Enrollment:	150
Study Start Date:	January 2013
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Behavioral: 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. Other Name: PaTE 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. Other Name: PaT
Active Comparator: Parents as Teachers 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 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. Other Name: PaT

Arms

Assigned Interventions

Experimental: 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

Behavioral: 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.

Other Name: PaTE

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.

Other Name: PaT

Active Comparator: Parents as Teachers

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

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.

Other Name: PaT

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

African American women
At least 18 years of age
Less than 18 weeks pregnant with first child
Resident of Mississippi counties of Washington and Bolivar

Exclusion Criteria:

Pregnant with more than one fetus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746394

Contacts

Contact: Melissa H Goodman, PhD

662-686-3918

melissa.goodman@ars.usda.gov

Locations

United States, Mississippi
USDA Agricultural Research Service Mid South Area Office	Not yet recruiting
Stoneville, Mississippi, United States, 38776
Contact: Melissa H Goodman, PhD 662-686-3918 melissa.goodman@ars.usda.gov
Contact: Jessica L Thomson, PhD 225-892-3662 jessica.thomson@ars.usda.gov
Principal Investigator: Jessica L Thomson, PhD
Sub-Investigator: Melissa H Goodman, PhD

Sponsors and Collaborators

USDA, Delta Human Nutrition Research Program

Investigators

Principal Investigator:

Jessica L Thomson, PhD

USDA Agricultural Research Service

More Information

Additional Information:

Parents as Teachers National Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	USDA, Delta Human Nutrition Research Program
ClinicalTrials.gov Identifier:	NCT01746394 History of Changes
Other Study ID Numbers:	DHN_12_01
Study First Received:	December 5, 2012
Last Updated:	December 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by USDA, Delta Human Nutrition Research Program:

obesity
pregnant women
nutrition assessment
health behavior

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013