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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746394
• Other study ID #: DHN_12_01
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: October 24, 2016
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: USDA, Delta Human Nutrition Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	USDA Agricultural Research Service Mid South Area Office	Stoneville	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Delta Human Nutrition Research Program

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maternal postpartum weight retention	Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight	12 months postnatal	No
Primary	Maternal dietary intake	Dietary intake measured using 24-hour dietary recall	12 months postpartum	No
Primary	Maternal physical activity	Physical activity measured using a physical activity questionnaire	12 months postpartum	No
Primary	Infant dietary intake	Dietary intake measured using 24-hour dietary recall as reported by mother	12 months after birth	No
Primary	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	No
Primary	Infant body mass index	Incremental body mass index during the first year of life	12 months after birth	No
Secondary	Breastfeeding	Breastfeeding initiation and continuation for first 12 months after birth of infant	12 months postpartum	No
Secondary	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)	12 months postpartum	No