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ObesityNCT01746394

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

A study testing Parents as Teachers Enhanced and Parents as Teachers in people with Obesity, run by USDA, Delta Human Nutrition Research Program at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Obesity
What is being tested?
Parents as Teachers Enhanced and Parents as Teachers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
Jan 2013to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnant with more than one fetus

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USDA Agricultural Research Service Mid South Area Office

    Stoneville, Mississippi, 38776

Other trials in United States

About this study

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

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.

Conditions
Obesity
Being tested
Parents as Teachers Enhanced, Parents as Teachers
Keywords
obesity, pregnant women, nutrition assessment, health behavior
Medical subject headings
Obesity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parents as Teachers EnhancedBehavioural

    Also called PaTE

    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 TeachersBehavioural

    Also called PaT

    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.

Study groups in NCT01746394
Study groupRoleWhat they receive
Parents as Teachers EnhancedExperimentalParticipants in the Parents as Teachers Enhanced (PaTE) intervention arm will receive the enhanced diet and activity maternal, infant, and early childhood home visiting program
Receives: Behavioral: Parents as Teachers Enhanced; Behavioral: Parents as Teachers
Parents as TeachersActive comparatorParticipants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program
Receives: Behavioral: Parents as Teachers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 9 months gestation

  2. Maternal postpartum weight retention

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

    Measured: 12 months postnatal

  3. Maternal dietary intake

    Dietary intake measured using 24-hour dietary recall

    Measured: 12 months postpartum

  4. Maternal physical activity

    Physical activity measured using a physical activity questionnaire

    Measured: 12 months postpartum

  5. Infant dietary intake

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

    Measured: 12 months after birth

  6. Infant activity

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

    Measured: 12 months after birth

  7. Infant body mass index

    Incremental body mass index during the first year of life

    Measured: 12 months after birth

Secondary outcomes (2)

  1. Breastfeeding

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

    Measured: 12 months postpartum

  2. 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)

    Measured: 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746394
Sponsor's protocol ID
DHN_12_01
Status last verified
Feb 2016
First submitted
5 Dec 2012
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24685997

  • 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.

    PubMed 29785275

  • 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.

    PubMed 29396153

  • 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.

    PubMed 29214042

  • 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.

    PubMed 28405211

  • 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.

    PubMed 27779937

  • 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.

    PubMed 27595023

  • 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.

    PubMed 27536380

Questions about this trial

What is this clinical trial studying?

A study testing Parents as Teachers Enhanced and Parents as Teachers in people with Obesity, run by USDA, Delta Human Nutrition Research Program at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain (time frame: 9 months gestation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746394, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.

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