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Completed

NCT Number: NCT03652766

Pregnancy Weight Tracking Pilot Project

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Daily Weight Tracking

Behavioral

Daily weight tracking + weekly email or text message feedback

Primary outcomes

  1. Adherence (protocol feasibility)

    Time frame: 6 weeks

    Frequency of bathroom scale use under daily weight tracking instruction condition

Secondary outcomes

  1. Acceptability (protocol)

    Time frame: 6 weeks

    Preferences and beliefs regarding daily weight tracking instruction condition

  2. Gestational Weight Gain

    Time frame: 6 weeks

    Weight gain during pregnancy under daily weight tracking instruction condition

  3. Gestational Weight Gain Knowledge

    Time frame: 6 weeks

    Use of bathroom scale and understanding of recommendations for gestational weight gain

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: PTRK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2018
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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