Back to results

Pregnancy Tracking Pilot

Primary Purpose

Gestational Weight Gain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Daily weighing

About this trial

This is an interventional supportive care trial for Gestational Weight Gain focused on measuring pregnancy, digital health, daily weighing

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Duke Global Digital Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tracking group

Arm Description

Participants will be asked to track weight daily for six weeks

Outcomes

Primary Outcome Measures

Frequency of scale use

The number of times weight is measured on the scale

Secondary Outcome Measures

Weight change trajectories during scale use

Average weight change over the study duration

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

Full Information

NCT ID

NCT04025892

First Posted

July 17, 2019

Last Updated

March 5, 2020

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT04025892

Brief Title

Pregnancy Tracking Pilot

Official Title

A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Inadequate resources to support study start-up

Study Start Date

March 2020 (Anticipated)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Weight Gain

Keywords

pregnancy, digital health, daily weighing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tracking group

Arm Type

Experimental

Arm Description

Participants will be asked to track weight daily for six weeks

Intervention Type

Behavioral

Intervention Name(s)

Daily weighing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Frequency of scale use

Description

The number of times weight is measured on the scale

Time Frame

Approximately 6 weeks

Secondary Outcome Measure Information:

Title

Weight change trajectories during scale use

Description

Average weight change over the study duration

Time Frame

Approximately 6 weeks

Title

Knowledge of gestational weight gain guidelines

Description

Score of response from baseline survey item inquiring about awareness of gestational weight gain where greater score indicates greater knowledge

Time Frame

During baseline visit (~ 1 hour)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

34 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dori Steinberg

Organizational Affiliation

DUSON

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Global Digital Health Science Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27708

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pregnancy Tracking Pilot

We'll reach out to this number within 24 hrs