Pregnancy Tracking Pilot

Gestational Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04025892
• Other study ID #: Pro00102563
• Status: Withdrawn
• Phase: N/A
• Start date: March 2020
• Est. completion date: May 2020

Study information

• Verified date: May 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gestational Weight Gain
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Global Digital Health Science Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of scale use	The number of times weight is measured on the scale	Approximately 6 weeks
Secondary	Weight change trajectories during scale use	Average weight change over the study duration	Approximately 6 weeks
Secondary	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	During baseline visit (~ 1 hour)