Promoting Appropriate Weight Gain Pregnant Women

Pregnancy Clinical Trial

— GRUVE  

Official title:

Promoting Appropriate Weight Gain Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180878
• Other study ID #: 13749
• Status: Completed
• Phase: N/A
• Start date: June 26, 2013
• Est. completion date: February 3, 2016

Study information

• Verified date: November 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 3, 2016
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 12-16 weeks pregnant

• Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion Criteria:

• Diabetes

• Pre-eclampsia

• Hypertension

• Other metabolic abnormalities

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Intervention
Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
• Intervention 2
Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excessive gestational weight gain	Proportion of excessive gestational weight gain based on weight gain guidelines.	During Pregnancy - 18-36 week gestational age
Secondary	Gestational weight gain	Total weight change during pregnancy	During Pregnancy - 18-36 week gestational age
Secondary	Infant fat mass	Infant fat mass	1-4 days after birth