Pregnancy Tracking Pilot

Not Applicable

Withdrawn

• Conditions: Gestational Weight Gain
• Interventions: Behavioral: Daily weighing

• Registration Number: NCT04025892
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tracking group	Daily weighing	Participants will be asked to track weight daily for six weeks

Primary Outcome Measures

Name	Time	Method
Frequency of scale use	Approximately 6 weeks	The number of times weight is measured on the scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke Global Digital Health Science Center; 🇺🇸 Durham, North Carolina, United States