Promoting Appropriate Weight Gain Pregnant Women (GRUVE)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Intervention 2

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Participants in this group were informed to continue to receive usual care.
Experimental: Intervention Arm; Received an interactive physical activity monitoring system (the Gruve®).	Behavioral: Intervention; Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
Experimental: Intervention Arm 2; Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excessive gestational weight gain	Proportion of excessive gestational weight gain based on weight gain guidelines.	During Pregnancy - 18-36 week gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain	Total weight change during pregnancy	During Pregnancy - 18-36 week gestational age
Infant fat mass	Infant fat mass	1-4 days after birth

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Holly R Hull, PhD, The University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2013
• Primary Completion (Actual): December 16, 2015
• Study Completion (Actual): February 3, 2016

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Gestational weight gain
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: 13749

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No