Pregnancy Weight Tracking Pilot Project

Obesity Complicating Childbirth Clinical Trial

— PTRK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652766
• Other study ID #: FWA00000312-9
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: March 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity Complicating Childbirth

Intervention

Behavioral:
• Daily Weight Tracking
Daily weight tracking + weekly email or text message feedback

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence (protocol feasibility)	Frequency of bathroom scale use under daily weight tracking instruction condition	6 weeks
Secondary	Acceptability (protocol)	Preferences and beliefs regarding daily weight tracking instruction condition	6 weeks
Secondary	Gestational Weight Gain	Weight gain during pregnancy under daily weight tracking instruction condition	6 weeks
Secondary	Gestational Weight Gain Knowledge	Use of bathroom scale and understanding of recommendations for gestational weight gain	6 weeks