Pregnancy Tracking Pilot

NCT ID: NCT04025892

Last Updated: 2020-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Weight Gain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tracking group

Participants will be asked to track weight daily for six weeks

Group Type EXPERIMENTAL

Daily weighing

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Daily weighing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dori Steinberg

Role: PRINCIPAL_INVESTIGATOR

DUSON

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke Global Digital Health Science Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00102563

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Low Carb vs Normal Carb in Pregnancy
NCT03749889 TERMINATED NA
Managing Weight in Pregnancy
NCT01770522 COMPLETED
Sleep Behaviors in Pregnancy
NCT04205370 RECRUITING NA