Obesity Complicating ChildbirthPTRKNCT03652766
Pregnancy Weight Tracking Pilot Project
A study testing Daily Weight Tracking in people with Obesity Complicating Childbirth, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity Complicating Childbirth
- What is being tested?
- Daily Weight Tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity Complicating Childbirth
- Being tested
- Daily Weight Tracking
- Keywords
- Overweight, Obesity, e-Health, Gestational Weight Gain, Pregnancy, Women's Health, Prevention
- Medical subject headings
- Overweight, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Weight TrackingBehavioural
Daily weight tracking + weekly email or text message feedback
| Study group | Role | What they receive |
|---|---|---|
| Daily Weight Tracking | Other | 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. Receives: Behavioral: Daily Weight Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence (protocol feasibility)
Frequency of bathroom scale use under daily weight tracking instruction condition
Measured: 6 weeks
Secondary outcomes (3)
Acceptability (protocol)
Preferences and beliefs regarding daily weight tracking instruction condition
Measured: 6 weeks
Gestational Weight Gain
Weight gain during pregnancy under daily weight tracking instruction condition
Measured: 6 weeks
Gestational Weight Gain Knowledge
Use of bathroom scale and understanding of recommendations for gestational weight gain
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start7 Jan 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Complicating ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group feasibility and acceptability trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer A Linde, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652766
- Sponsor's protocol ID
- FWA00000312-9
- Acronym
- PTRK
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
- ClinicalTrials.gov ID
- NCT03652766
- Acronym / sponsor ID
- PTRK / FWA00000312-9
- Conditions
- Obesity Complicating Childbirth
- Keywords
- Overweight, Obesity, e-Health, Gestational Weight Gain, Pregnancy, Women's Health, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group feasibility and acceptability trial
| Arm | Type | Receives |
|---|---|---|
| Daily Weight Tracking | Other | Behavioral: Daily Weight TrackingParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Weight TrackingDaily weight tracking + weekly email or text message feedback | Behavioural | Daily Weight Tracking |
Primary outcome
Adherence (protocol feasibility)
Time frame: 6 weeks
Frequency of bathroom scale use under daily weight tracking instruction condition
3 secondary outcomes
Acceptability (protocol)
Time frame: 6 weeks
Gestational Weight Gain
Time frame: 6 weeks
Gestational Weight Gain Knowledge
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Linde, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Weight Tracking in people with Obesity Complicating Childbirth, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (protocol feasibility) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.