ClinicalTrials.gg
CompletedNCT04180878GRUVEUpdated Aug 2, 2024

Promoting Appropriate Weight Gain Pregnant Women

An interventional study of Intervention and Intervention 2 in Pregnancy, sponsored by University of Kansas Medical Center. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 years 4 months after the study started (first participant enrolled Jun 2013, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pregnancy

Keywords

  • Gestational weight gain
  • Physical activity
03

In context

Gestational Weight Gain

123 studies on the registry are indexed under Gestational Weight Gain; 20 are open to participants now.

This study's enrollment of 32 is below the median of 108 across 103 interventional studies indexed under Gestational Weight Gain.

Browse Gestational Weight Gain studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 12-16 weeks pregnant
  • Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Pre-eclampsia
  • Hypertension
  • Other metabolic abnormalities
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • Experimental
    Intervention Arm 2

    Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC).

    Behavioral: Intervention 2

Interventions

  • BehavioralIntervention

    Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.

  • BehavioralIntervention 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.

06

What researchers measure

Primary outcomes

  1. Excessive gestational weight gain

    Proportion of excessive gestational weight gain based on weight gain guidelines.

    Time frame: During Pregnancy - 18-36 week gestational age

Secondary outcomes

  1. Gestational weight gain

    Total weight change during pregnancy

    Time frame: During Pregnancy - 18-36 week gestational age

  2. Infant fat mass

    Infant fat mass

    Time frame: 1-4 days after birth

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2013 to primary completion in Dec 2015, 29 months.

Of 78 non-industry interventional studies with no phase under Gestational Weight Gain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 29 months is above that.

Counting every sponsor, half of 78 studies reached it within 24 months; a quarter within 13 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2019
First posted
Nov 29, 2019
StartActual
Jun 26, 2013
Primary completionActual
Dec 16, 2015
CompletionActual
Feb 3, 2016
Last update
Aug 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04180878
Responsible party
Sponsor
First posted
Nov 29, 2019
Start date
Jun 26, 2013
Primary completion
Dec 16, 2015
Completion
Feb 3, 2016
Last update
Aug 2, 2024

Study contacts

Holly R Hull, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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