PregnancyGRUVENCT04180878
Promoting Appropriate Weight Gain Pregnant Women
A study testing Intervention and Intervention 2 in people with Pregnancy, run by University of Kansas Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Intervention and Intervention 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2013to 3 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 12-16 weeks pregnant
- Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2
Who cannot join
- Diabetes
- Pre-eclampsia
- Hypertension
- Other metabolic abnormalities
About this study
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.
- Conditions
- Pregnancy
- Being tested
- Intervention, Intervention 2
- Keywords
- Gestational weight gain, Physical activity
- Medical subject headings
- Gestational Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
Intervention 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants in this group were informed to continue to receive usual care. |
| Intervention Arm | Experimental | Received an interactive physical activity monitoring system (the Gruve®). Receives: Behavioral: Intervention |
| Intervention Arm 2 | Experimental | Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC). Receives: Behavioral: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive gestational weight gain
Proportion of excessive gestational weight gain based on weight gain guidelines.
Measured: During Pregnancy - 18-36 week gestational age
Secondary outcomes (2)
Gestational weight gain
Total weight change during pregnancy
Measured: During Pregnancy - 18-36 week gestational age
Infant fat mass
Infant fat mass
Measured: 1-4 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start26 Jun 2013
- Primary completion16 Dec 2015
- Study completion3 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly R Hull, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180878
- Sponsor's protocol ID
- 13749
- Acronym
- GRUVE
- Status last verified
- Jul 2024
- First submitted
- 14 Nov 2019
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Appropriate Weight Gain Pregnant Women
- ClinicalTrials.gov ID
- NCT04180878
- Acronym / sponsor ID
- GRUVE / 13749
- Conditions
- Pregnancy
- Keywords
- Gestational weight gain, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 26 Jun 2013 (actual)
- Primary completion
- 16 Dec 2015 (actual)
- Study completion
- 3 Feb 2016 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants in this group were informed to continue to receive usual care. |
| Intervention Arm | Experimental | Behavioral: InterventionReceived an interactive physical activity monitoring system (the Gruve®). |
| Intervention Arm 2 | Experimental | Behavioral: Intervention 2Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 12-16 weeks pregnant
- Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2
Key exclusion criteria (4 listed)
- Diabetes
- Pre-eclampsia
- Hypertension
- Other metabolic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionParticipants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level. | Behavioural | Intervention Arm |
| Intervention 2Participants 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. | Behavioural | Intervention Arm 2 |
Primary outcome
Excessive gestational weight gain
Time frame: During Pregnancy - 18-36 week gestational age
Proportion of excessive gestational weight gain based on weight gain guidelines.
2 secondary outcomes
Gestational weight gain
Time frame: During Pregnancy - 18-36 week gestational age
Infant fat mass
Time frame: 1-4 days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly R Hull, PhD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Intervention 2 in people with Pregnancy, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excessive gestational weight gain (time frame: During Pregnancy - 18-36 week gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.