- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025892
Pregnancy Tracking Pilot
March 5, 2020 updated by: Duke University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27708
- Duke Global Digital Health Science Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tracking group
Participants will be asked to track weight daily for six weeks
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of scale use
Time Frame: Approximately 6 weeks
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The number of times weight is measured on the scale
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Approximately 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change trajectories during scale use
Time Frame: Approximately 6 weeks
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Average weight change over the study duration
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Approximately 6 weeks
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Knowledge of gestational weight gain guidelines
Time Frame: During baseline visit (~ 1 hour)
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Score of response from baseline survey item inquiring about awareness of gestational weight gain where greater score indicates greater knowledge
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During baseline visit (~ 1 hour)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dori Steinberg, DUSON
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
July 17, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 19, 2019
Study Record Updates
Last Update Posted (Actual)
March 9, 2020
Last Update Submitted That Met QC Criteria
March 5, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00102563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Weight Gain
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
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Andalas UniversityNational Institute of Health Research and Development, Ministry of Health...CompletedBirth Weight | Pregnancy Weight GainIndonesia
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T.C. ORDU ÜNİVERSİTESİEge UniversityCompletedGestational Weight GainTurkey
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University of HawaiiCompletedGestational Weight GainUnited States
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Helena PiccininiNova Scotia Health AuthorityWithdrawnGestational Weight GainCanada
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West China HospitalWest China Second University HospitalCompleted
-
Technical University of MadridCompleted
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Arizona State UniversityKripalu Center for Yoga and HealthCompletedWeight GainUnited States
-
University of Kansas Medical CenterCompleted
-
Milton S. Hershey Medical CenterWithdrawn
Clinical Trials on Daily weighing
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Cornell UniversityCompleted
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Cornell UniversityCompleted
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University of North Carolina, Chapel HillCompleted
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University of DelawareCompletedDaily Self-weighing | Daily Temperature-takingUnited States
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University of Alabama at BirminghamIndiana University; Cornell UniversityActive, not recruitingOverweight and ObesityUnited States
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University of GeorgiaCompleted
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The University of Tennessee, KnoxvilleCompleted
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The Miriam HospitalCompleted
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Milton S. Hershey Medical CenterRecruitingAnorexia Nervosa | Eating DisordersUnited States
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University Hospital, GrenobleUnknownHospitalisation for PneumoniaFrance