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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by USDA, Delta Human Nutrition Research Program
Sponsor:
Information provided by (Responsible Party):
USDA, Delta Human Nutrition Research Program
ClinicalTrials.gov Identifier:
NCT01746394
First received: December 5, 2012
Last updated: April 3, 2014
Last verified: April 2014
  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:


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: January 2017
Estimated Primary Completion Date: January 2017 (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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Study Chair: Lisa M Tussing-Humphreys, PhD University of Illinois at Chicago
  More Information

Additional Information:
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: April 3, 2014
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
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014