Clinical trial NCT03652766: Pregnancy Weight Tracking Pilot Project
Official title: A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Complicating Childbirth
Keywords: Overweight
Obesity
e-Health
Gestational Weight Gain
Pregnancy
Women's Health
Prevention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group feasibility and acceptability trial
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Adherence (protocol feasibility)
timeFrame: 6 weeks
Secondary outcomes:
measure: Acceptability (protocol)
timeFrame: 6 weeks
measure: Gestational Weight Gain
timeFrame: 6 weeks
measure: Gestational Weight Gain Knowledge
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jennifer A Linde, PhD
role: PRINCIPAL_INVESTIGATOR
References: