Maternal, Pregnancy Related, Weight Gain
Conditions
Brief summary
The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.
Detailed description
This proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .Additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions. In this study, the investigators will develop and adapt an intervention (Self-Management Around the Reproductive Transition; SMART) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the SMART intervention.
Interventions
BEHAVIORALSMART Intervention
Counseling sessions will be conducted by research project staff that has, at least, masters level or equivalent degrees. Sessions will occur up to 10 times at their regularly scheduled obstetric appointments and also weekly by phone and text messages. In person sessions will last approximately 20-30 minutes.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participant will be provided with counseling sessions throughout the course of their pregnancy.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 14 years of age * Less than 16 weeks gestation * English speaking * Singleton pregnancy * Receiving care at Magee-Womens Hospital, Latterman family health or other UPMC practices that provide obstetric care
Exclusion criteria
* Preexisting diabetes * Use of medications known to affect weight * Enrolled in current weight management programming * History of weight loss surgery * Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of sessions attended among women enrolled in the study | Approximately 9 months | Number of sessions attended will be calculated for each participant |
| Number of self-monitoring forms returned | Approximately 9 months | Number of self-monitoring forms returned will be calculated for each participant |
| Gestational weight gain | Approximately 9 months | Gestational weight gain will be calculated for each participant. Weight in pounds will be measured on a calibrated scale while women are in street clothes without shoes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Approximately 12 months | The Center for Epidemiological Studies-Depression Scale will be used to assess depressive symptomatology. A total scores is calculated by finding the sum of the 20 items. Total scores range from 0-60, with higher scores reflecting greater depressive symptomatology. |
| Perceived stress symptoms | Approximately 12 months | The Perceived Stress Scale will be administered to measure symptoms of perceived stress. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40. Higher scores indicate greater perceived stress. |
Countries
United States
Outcome results
None listed