Strategies for Self-Management Around the Reproductive Transition: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of sessions attended among women enrolled in the study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
SMART Intervention
Counseling sessions will be completed with a toolbox approach so that clinicians can work on topics that are of interest and relevant to each participant. SMART will focus on weight, physical activity, eating and psychosocial issues. Intervention goals will emphasize adherence to healthy behaviors rather than absolute weight goals. Specifically, women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included.
Intervention: SMART Intervention (Behavioral)
Outcomes
Primary Outcomes
Number of sessions attended among women enrolled in the study
Time Frame: Approximately 9 months
Number of sessions attended will be calculated for each participant
Number of self-monitoring forms returned
Time Frame: Approximately 9 months
Number of self-monitoring forms returned will be calculated for each participant
Gestational weight gain
Time Frame: 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 Outcomes
- Depressive symptoms(Approximately 12 months)
- Perceived stress symptoms(Approximately 12 months)
Investigators
Michele Levine
Associate Professor
University of Pittsburgh