A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

Pregnancy Related Clinical Trial

Official title:

Strategies for Self-Management Around the Reproductive Transition: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143008
• Other study ID #: PRO15060569
• Status: Completed
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: February 19, 2017

Study information

• Verified date: December 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 19, 2017
• Est. primary completion date: February 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal
• Pregnancy Related
• Weight Gain

Intervention

Behavioral:
• SMART 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended among women enrolled in the study	Number of sessions attended will be calculated for each participant	Approximately 9 months
Primary	Number of self-monitoring forms returned	Number of self-monitoring forms returned will be calculated for each participant	Approximately 9 months
Primary	Gestational weight gain	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.	Approximately 9 months
Secondary	Depressive symptoms	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.	Approximately 12 months
Secondary	Perceived stress symptoms	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.	Approximately 12 months