Pregnancy Tracking Pilot

Sponsor

Duke University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04025892

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Weight Gain	Behavioral: Daily weighing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tracking group Participants will be asked to track weight daily for six weeks	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Tracking group

Participants will be asked to track weight daily for six weeks

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Frequency of scale use [Approximately 6 weeks]
The number of times weight is measured on the scale

Secondary Outcome Measures

Weight change trajectories during scale use [Approximately 6 weeks]
Average weight change over the study duration
Knowledge of gestational weight gain guidelines [During baseline visit (~ 1 hour)]
Score of response from baseline survey item inquiring about awareness of gestational weight gain where greater score indicates greater knowledge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 34 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Global Digital Health Science Center	Durham	North Carolina	United States	27708

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Dori Steinberg, DUSON

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT04025892

Other Study ID Numbers:

Pro00102563

First Posted:

Jul 19, 2019

Last Update Posted:

Mar 9, 2020

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Duke University

pregnancy

digital health

daily weighing

Additional relevant MeSH terms:

Weight Gain

Gestational Weight Gain

Study Results

No Results Posted as of Mar 9, 2020