Pregnancy Weight Tracking Pilot Project (PTRK)

March 27, 2020 updated by: University of Minnesota

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Excessive weight gain during pregnancy is predictive of a host of health outcomes in both the mother and child, particularly among women who are overweight or obese pre-pregnancy. Gaining too much weight is associated with higher risk of gestational diabetes, large birth weight for the baby and its corresponding risks, and postpartum obesity. Alarmingly, these outcomes persist for years after birth. For adults who are overweight or obese and interested in weight management, a key element of behavioral weight control is self-monitoring. Supported by self-regulation theory, the effectiveness of daily weighing is likely a function of the self-regulatory processes that are activated as a result of this behavior. Receiving feedback daily on weight proximal to diet and exercise behaviors may increase awareness how of behaviors impact weight and allow for small changes in weight to be understood and resolved through subsequent behavior change. Given the improvements in self-regulation as a result of daily weighing, it may be an effective strategy for reducing excessive gestational weight gain during pregnancy. It is not clear, however, whether pregnant women would engage in this behavior and whether daily weighing would be effective in promoting recommended levels of weight gain during pregnancy.

To determine the feasibility of a six-week, digital health daily weighing pilot intervention to monitor gestational weight gain among overweight and obese pregnant women, participants will be recruited at up to 20 weeks' gestation (consistent with prior studies) and will receive a digital wireless Bluetooth-enabled scale to track weight for six weeks during pregnancy. They will receive tailored feedback via weekly emails in response to adherence to daily weighing and whether weight gains are in accordance with recommended levels and healthy standards for pregnancy; weekly emails will also communicate healthy eating and physical activity tips for pregnancy. They will be asked to complete surveys at baseline (before using scales) and follow-up (after using scales) that focus on experiences with weight monitoring, GWG knowledge and expectations, and perceptions of the intervention process.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ages 18-35
  • Up to 20 weeks' gestation in their first pregnancy
  • Low-risk uncomplicated pregnancy
  • Have overweight or obesity just prior to becoming pregnant
  • Have an iPhone or Android smartphone with wireless/Bluetooth capability

Exclusion Criteria:

  • Individuals who are not pregnant
  • Second or subsequent pregnancy
  • No iPhone or Android smartphone with Bluetooth capacity
  • No wifi network at home
  • Expecting twins or other multiple
  • More than 20 weeks gestation
  • High-risk or complicated pregnancy for which participation would be contraindicated
  • Of advanced maternal age according to obstetric guidelines (i.e., age 36 or older)
  • Diabetes or history of eating disorders
  • Pre-pregnancy weight less than 25 kg/m2 or greater than 36 kg/m2 (either not overweight or with extreme obesity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Daily Weight Tracking
Participants will be provided with a wireless Bluetooth-enabled bathroom scale with instructions for connecting it to their home wifi network or phone using Bluetooth and a mobile app, and will also be walked through creating an anonymous study account for app access. They will be asked to track their weight daily for 6 weeks and will receive weekly feedback on weight gain trajectories along with nutrition or physical activity messages for healthy pregnancy weight gain.
Behavioral: Daily Weight Tracking
Daily weight tracking + weekly email or text message feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence (protocol feasibility)
Time Frame: 6 weeks
Frequency of bathroom scale use under daily weight tracking instruction condition
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (protocol)
Time Frame: 6 weeks
Preferences and beliefs regarding daily weight tracking instruction condition
6 weeks
Gestational Weight Gain
Time Frame: 6 weeks
Weight gain during pregnancy under daily weight tracking instruction condition
6 weeks
Gestational Weight Gain Knowledge
Time Frame: 6 weeks
Use of bathroom scale and understanding of recommendations for gestational weight gain
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Jennifer A Linde, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2019

Primary Completion (ACTUAL)

January 13, 2020

Study Completion (ACTUAL)

January 13, 2020

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA00000312-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to the link between identifiers (name and date of birth) and participants study ID numbers, which will be kept on paper in a locked file cabinet in a private office, will be limited to the investigator; only de-identified datasets will be shared with future grant submission collaborators as needed, and those files will be password-protected and shared via encrypted transmission.

IPD Sharing Time Frame

The data will be shared until the related NIH grant is submitted, for a period of no longer than one year.

IPD Sharing Access Criteria

Collaborators on NIH grant proposal submission for 2019.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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