Study Stopped
Inadequate resources to support study start-up
Pregnancy Tracking Pilot
A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
1 other identifier
interventional
N/A
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
Started Mar 2020
Shorter than P25 for not_applicable
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
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMarch 9, 2020
May 1, 2019
2 months
July 17, 2019
March 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of scale use
The number of times weight is measured on the scale
Approximately 6 weeks
Secondary Outcomes (2)
Weight change trajectories during scale use
Approximately 6 weeks
Knowledge of gestational weight gain guidelines
During baseline visit (~ 1 hour)
Study Arms (1)
Tracking group
EXPERIMENTALParticipants will be asked to track weight daily for six weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke Global Digital Health Science Center
Durham, North Carolina, 27708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dori Steinberg
DUSON
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 19, 2019
Study Start
March 1, 2020
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
March 9, 2020
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share