Pregnancy Tracking Pilot

Duke University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Gestational Weight Gain

Interventions

Daily weighingBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Duke Global Digital Health Science Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Frequency of scale use

The number of times weight is measured on the scale

Time frame: Approximately 6 weeks

Secondary Outcomes

Weight change trajectories during scale use

Average weight change over the study duration

Time frame: Approximately 6 weeks

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

Time frame: During baseline visit (~ 1 hour)

Data from ClinicalTrials.gov

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