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

Study Overview
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Parents as Teachers Enhanced
* Behavioral: Parents as Teachers


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parents as Teachers Enhanced<br>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<br>* 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.<br>* Other names: PaTE;Behavioral: Parents as Teachers<br>* 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.<br>* Other names: PaT;|
| Active Comparator: Parents as Teachers<br>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<br>* 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.<br>* Other names: PaT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maternal postpartum weight retention | Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight | 12 months postnatal | 
| Maternal dietary intake | Dietary intake measured using 24-hour dietary recall | 12 months postpartum | 
| Maternal physical activity | Physical activity measured using a physical activity questionnaire | 12 months postpartum | 
| Infant dietary intake | Dietary intake measured using 24-hour dietary recall as reported by mother | 12 months after birth | 
| 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 | 
| Infant body mass index | Incremental body mass index during the first year of life | 12 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding | Breastfeeding initiation and continuation for first 12 months after birth of infant | 12 months postpartum | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, pregnant women, nutrition assessment, health behavior