Pregnancy Tracking Pilot

Study Overview
=================
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.

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

Conditions
-----------------
Gestational Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Daily weighing


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tracking group<br>Participants will be asked to track weight daily for six weeks | Behavioral: Daily weighing<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of scale use | The number of times weight is measured on the scale | Approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change trajectories during scale use | Average weight change over the study duration | 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 | During baseline visit (  1 hour) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, digital health, daily weighing