Pregnancy Weight Tracking Pilot Project
PTRK
A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
1 other identifier
interventional
10
1 country
1
Brief 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 delivered remotely with electronic feedback to participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
1 active site
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
First Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedMarch 30, 2020
March 1, 2020
1 year
August 28, 2018
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence (protocol feasibility)
Frequency of bathroom scale use under daily weight tracking instruction condition
6 weeks
Secondary Outcomes (3)
Acceptability (protocol)
6 weeks
Gestational Weight Gain
6 weeks
Gestational Weight Gain Knowledge
6 weeks
Study Arms (1)
Daily Weight Tracking
OTHERParticipants will be provided with a wireless Bluetooth-enabled bathroom scale with instructions for connecting it to their home wifi network or phone using Bluetooth and a mobile app, and will also be walked through creating an anonymous study account for app access. They will be asked to track their weight daily for 6 weeks and will receive weekly feedback on weight gain trajectories along with nutrition or physical activity messages for healthy pregnancy weight gain.
Interventions
Daily weight tracking + weekly email or text message feedback
Eligibility Criteria
You may qualify if:
- Ages 18-35
- Up to 20 weeks' gestation in their first pregnancy
- Low-risk uncomplicated pregnancy
- Have overweight or obesity just prior to becoming pregnant
- Have an iPhone or Android smartphone with wireless/Bluetooth capability
You may not qualify if:
- Individuals who are not pregnant
- Second or subsequent pregnancy
- No iPhone or Android smartphone with Bluetooth capacity
- No wifi network at home
- Expecting twins or other multiple
- More than 20 weeks gestation
- High-risk or complicated pregnancy for which participation would be contraindicated
- Of advanced maternal age according to obstetric guidelines (i.e., age 36 or older)
- Diabetes or history of eating disorders
- Pre-pregnancy weight less than 25 kg/m2 or greater than 36 kg/m2 (either not overweight or with extreme obesity)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer A Linde, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2018
First Posted
August 29, 2018
Study Start
January 7, 2019
Primary Completion
January 13, 2020
Study Completion
January 13, 2020
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be shared until the related NIH grant is submitted, for a period of no longer than one year.
- Access Criteria
- Collaborators on NIH grant proposal submission for 2019.
Access to the link between identifiers (name and date of birth) and participants study ID numbers, which will be kept on paper in a locked file cabinet in a private office, will be limited to the investigator; only de-identified datasets will be shared with future grant submission collaborators as needed, and those files will be password-protected and shared via encrypted transmission.