Gestational Weight GainNCT04025892
Pregnancy Tracking Pilot
A study testing Daily weighing in people with Gestational Weight Gain, run by Duke University at 1 site in United States.
Trial summary
This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention… Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Daily weighing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to May 2020
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women ages 18-34
- first pregnancy and at 13-20 weeks' gestation
- low-risk uncomplicated pregnancy
- overweight or obese at the time they became pregnant
- willing to receive emails.
Who cannot join
- Individuals who are not pregnant
- not willing to receive emails
- pregnant women expecting more than a single birth,
- outside the window of 13-20 weeks' gestation
- high-risk or complicated pregnancy for which participation would be contraindicated
- advanced maternal age according to obstetric guidelines (i.e., age 35 or older)
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- diabetes
- history of eating disorders
- pre-pregnancy weight less than 25 kg/m2or greater than 36 kg/m2 (either not overweight or with extreme obesity)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Global Digital Health Science Center
Durham, North Carolina, 27708
About this study
Official title: A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.
- Conditions
- Gestational Weight Gain
- Being tested
- Daily weighing
- Keywords
- pregnancy, digital health, daily weighing
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily weighingBehavioural
Participants will be asked to use the scale to track their body weight daily at home for six weeks. They will receive a weekly email contact with weight change feedback and either a nutrition or physical activity tip for the week. The study procedures represent minimal risks, and participants will be reminded and encouraged to maintain their regular prenatal care contacts with their provider.
| Study group | Role | What they receive |
|---|---|---|
| Tracking group | Experimental | Participants will be asked to track weight daily for six weeks Receives: Behavioral: Daily weighing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of scale use
The number of times weight is measured on the scale
Measured: Approximately 6 weeks
Secondary outcomes (2)
Weight change trajectories during scale use
Average weight change over the study duration
Measured: Approximately 6 weeks
Knowledge of gestational weight gain guidelines
Score of response from baseline survey item inquiring about awareness of gestational weight gain where greater score indicates greater knowledge
Measured: During baseline visit (~ 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study startMar 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Inadequate resources to support study start-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dori Steinberg, Principal investigator, DUSON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025892
- Sponsor's protocol ID
- Pro00102563
- Status last verified
- May 2019
- First submitted
- 17 Jul 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
- ClinicalTrials.gov ID
- NCT04025892
- Acronym / sponsor ID
- Pro00102563
- Conditions
- Gestational Weight Gain
- Keywords
- pregnancy, digital health, daily weighing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate resources to support study start-up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Jul 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.
This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracking group | Experimental | Behavioral: Daily weighingParticipants will be asked to track weight daily for six weeks |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women ages 18-34
- first pregnancy and at 13-20 weeks' gestation
- low-risk uncomplicated pregnancy
- overweight or obese at the time they became pregnant
- willing to receive emails.
Key exclusion criteria (9 listed)
- Individuals who are not pregnant
- not willing to receive emails
- pregnant women expecting more than a single birth,
- outside the window of 13-20 weeks' gestation
- high-risk or complicated pregnancy for which participation would be contraindicated
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 |
|---|---|---|
| Daily weighingParticipants will be asked to use the scale to track their body weight daily at home for six weeks. They will receive a weekly email contact with weight change feedback and either a nutrition or physical activity tip for the week. The study procedures represent minimal risks, and participants will be reminded and encouraged to maintain their regular prenatal care contacts with their provider. | Behavioural | Tracking group |
Primary outcome
Frequency of scale use
Time frame: Approximately 6 weeks
The number of times weight is measured on the scale
2 secondary outcomes
Weight change trajectories during scale use
Time frame: Approximately 6 weeks
Knowledge of gestational weight gain guidelines
Time frame: During baseline visit (~ 1 hour)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No
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Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
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Healthy Adaptation to Pregnancy, Postpartum and Parenthood
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An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
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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.
Dori Steinberg principal investigator
DUSON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily weighing in people with Gestational Weight Gain, run by Duke University at 1 site in United States.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of scale use (time frame: Approximately 6 weeks). 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 9 Mar 2020.