Pregnancy Weight Tracking Pilot Project (PTRK)
Primary Purpose
Obesity Complicating Childbirth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Weight Tracking
Sponsored by
About this trial
This is an interventional other trial for Obesity Complicating Childbirth focused on measuring Overweight, Obesity, e-Health, Gestational Weight Gain, Pregnancy, Women's Health, Prevention
Eligibility Criteria
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)
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Daily Weight Tracking
Arm Description
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.
Outcomes
Primary Outcome Measures
Adherence (protocol feasibility)
Frequency of bathroom scale use under daily weight tracking instruction condition
Secondary Outcome Measures
Acceptability (protocol)
Preferences and beliefs regarding daily weight tracking instruction condition
Gestational Weight Gain
Weight gain during pregnancy under daily weight tracking instruction condition
Gestational Weight Gain Knowledge
Use of bathroom scale and understanding of recommendations for gestational weight gain
Full Information
NCT ID
NCT03652766
First Posted
August 28, 2018
Last Updated
March 27, 2020
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03652766
Brief Title
Pregnancy Weight Tracking Pilot Project
Acronym
PTRK
Official Title
A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Complicating Childbirth
Keywords
Overweight, Obesity, e-Health, Gestational Weight Gain, Pregnancy, Women's Health, Prevention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group feasibility and acceptability trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Weight Tracking
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Weight Tracking
Intervention Description
Daily weight tracking + weekly email or text message feedback
Primary Outcome Measure Information:
Title
Adherence (protocol feasibility)
Description
Frequency of bathroom scale use under daily weight tracking instruction condition
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Acceptability (protocol)
Description
Preferences and beliefs regarding daily weight tracking instruction condition
Time Frame
6 weeks
Title
Gestational Weight Gain
Description
Weight gain during pregnancy under daily weight tracking instruction condition
Time Frame
6 weeks
Title
Gestational Weight Gain Knowledge
Description
Use of bathroom scale and understanding of recommendations for gestational weight gain
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Linde, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Pregnancy Weight Tracking Pilot Project
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