Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parents as Teachers Enhanced
Parents as Teachers
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, pregnant women, nutrition assessment, health behavior
Eligibility 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
Sites / Locations
- USDA Agricultural Research Service Mid South Area Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parents as Teachers Enhanced
Parents as Teachers
Arm Description
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
Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program
Outcomes
Primary Outcome Measures
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)
Maternal postpartum weight retention
Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight
Maternal dietary intake
Dietary intake measured using 24-hour dietary recall
Maternal physical activity
Physical activity measured using a physical activity questionnaire
Infant dietary intake
Dietary intake measured using 24-hour dietary recall as reported by mother
Infant activity
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
Incremental body mass index during the first year of life
Secondary Outcome Measures
Breastfeeding
Breastfeeding initiation and continuation for first 12 months after birth of infant
Home food environment
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)
Full Information
NCT ID
NCT01746394
First Posted
December 5, 2012
Last Updated
October 24, 2016
Sponsor
USDA, Delta Human Nutrition Research Program
1. Study Identification
Unique Protocol Identification Number
NCT01746394
Brief Title
Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Delta Human Nutrition Research Program
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, pregnant women, nutrition assessment, health behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parents as Teachers Enhanced
Arm Type
Experimental
Arm Description
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
Arm Title
Parents as Teachers
Arm Type
Active Comparator
Arm Description
Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program
Intervention Type
Behavioral
Intervention Name(s)
Parents as Teachers Enhanced
Other Intervention Name(s)
PaTE
Intervention Description
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
Intervention Name(s)
Parents as Teachers
Other Intervention Name(s)
PaT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)
Time Frame
9 months gestation
Title
Maternal postpartum weight retention
Description
Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight
Time Frame
12 months postnatal
Title
Maternal dietary intake
Description
Dietary intake measured using 24-hour dietary recall
Time Frame
12 months postpartum
Title
Maternal physical activity
Description
Physical activity measured using a physical activity questionnaire
Time Frame
12 months postpartum
Title
Infant dietary intake
Description
Dietary intake measured using 24-hour dietary recall as reported by mother
Time Frame
12 months after birth
Title
Infant activity
Description
Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)
Time Frame
12 months after birth
Title
Infant body mass index
Description
Incremental body mass index during the first year of life
Time Frame
12 months after birth
Secondary Outcome Measure Information:
Title
Breastfeeding
Description
Breastfeeding initiation and continuation for first 12 months after birth of infant
Time Frame
12 months postpartum
Title
Home food environment
Description
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)
Time Frame
12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Thomson, PhD
Organizational Affiliation
USDA Agricultural Research Service
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa M Tussing-Humphreys, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
USDA Agricultural Research Service Mid South Area Office
City
Stoneville
State/Province
Mississippi
ZIP/Postal Code
38776
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24685997
Citation
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.
Results Reference
background
PubMed Identifier
29785275
Citation
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.
Results Reference
derived
PubMed Identifier
29396153
Citation
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.
Results Reference
derived
PubMed Identifier
29214042
Citation
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.
Results Reference
derived
PubMed Identifier
28405211
Citation
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.
Results Reference
derived
PubMed Identifier
27779937
Citation
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.
Results Reference
derived
PubMed Identifier
27595023
Citation
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.
Results Reference
derived
PubMed Identifier
27536380
Citation
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.
Results Reference
derived
Learn more about this trial
Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta
We'll reach out to this number within 24 hrs