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Completed

NCT Number: NCT01746394

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USDA Agricultural Research Service Mid South Area Office

Stoneville, Mississippi, 38776, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parents as Teachers Enhanced

Behavioral

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 names: PaTE

Parents as Teachers

Behavioral

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 names: PaT

Primary outcomes

  1. Gestational weight gain

    Time frame: 9 months gestation

    Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)

  2. Maternal postpartum weight retention

    Time frame: 12 months postnatal

    Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight

  3. Maternal dietary intake

    Time frame: 12 months postpartum

    Dietary intake measured using 24-hour dietary recall

  4. Maternal physical activity

    Time frame: 12 months postpartum

    Physical activity measured using a physical activity questionnaire

  5. Infant dietary intake

    Time frame: 12 months after birth

    Dietary intake measured using 24-hour dietary recall as reported by mother

  6. Infant activity

    Time frame: 12 months after birth

    Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)

  7. Infant body mass index

    Time frame: 12 months after birth

    Incremental body mass index during the first year of life

Secondary outcomes

  1. Breastfeeding

    Time frame: 12 months postpartum

    Breastfeeding initiation and continuation for first 12 months after birth of infant

  2. Home food environment

    Time frame: 12 months postpartum

    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)

Sponsors and collaborators

Lead sponsor

USDA, Delta Human Nutrition Research Program

Fed

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2012
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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