Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness

Primary Care Clinical Trial

Official title:

Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00782028
• Other study ID #: R21 HDJ2810-01A1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: October 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have:

• Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking.

• Better health care use for babies: i.e. attend more care visits, on-time and complete immunizations and decreased emergency services use.

• Better psychosocial outcomes for the families: i.e. decreased stress and depression, and increased social support.

• Improved parenting skills: i.e. improved knowledge of child development, involvement in developmentally appropriate activities, and parental sense of competence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postpartum woman with baby in her care

• Receive well-woman care, well-child care and interviews in English

• Willingness to receive care in a group setting

• Woman planning to receive care at the Yale Women's Center for herself and the Primary Care Center for her baby

Exclusion Criteria:

• severe medical problem requiring individualized care for mother or baby

• Baby born at less than 37 weeks gestation

• Baby remaining in hospital when mother getting discharged for any other reason except hyperbilirubinemia

• Baby with severe cardiac, respiratory, neuro-developmental or surgical problems

Study Design

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

Related Conditions & MeSH terms

• Primary Care

Intervention

Other:
• Centering parenting/Group well child care
Intervention families will receive well child care in a group format for the first 12 month of the child's life.
• Standard Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved maternal and child health behaviors will be measured using a computer assisted interview.		Interviews will be given at 2 weeks, 6 and 12 months of age.	No
Secondary	Better health care utilization for babies will be measured using Medical records review.		1 year	No
Secondary	Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview.		2 weeks, 6 months and 12 months of age	No
Secondary	Improved parenting skills will be assessed using a computer assisted inteview.		2 weeks, 6 months ad 12 months	No