Promoting Appropriate Weight Gain Pregnant Women
GRUVE
1 other identifier
interventional
32
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Jun 2013
Typical duration for not_applicable pregnancy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2016
CompletedFirst Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 29, 2019
CompletedAugust 2, 2024
July 1, 2024
2.5 years
November 14, 2019
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Excessive gestational weight gain
Proportion of excessive gestational weight gain based on weight gain guidelines.
During Pregnancy - 18-36 week gestational age
Secondary Outcomes (2)
Gestational weight gain
During Pregnancy - 18-36 week gestational age
Infant fat mass
1-4 days after birth
Study Arms (3)
Control Arm
NO INTERVENTIONParticipants in this group were informed to continue to receive usual care.
Intervention Arm
EXPERIMENTALReceived an interactive physical activity monitoring system (the Gruve®).
Intervention Arm 2
EXPERIMENTALReceived an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC).
Interventions
Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
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.
Eligibility Criteria
You may qualify if:
- weeks pregnant
- Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2
You may not qualify if:
- Diabetes
- Pre-eclampsia
- Hypertension
- Other metabolic abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly R Hull, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 29, 2019
Study Start
June 26, 2013
Primary Completion
December 16, 2015
Study Completion
February 3, 2016
Last Updated
August 2, 2024
Record last verified: 2024-07