A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

Not Applicable

Completed

• Conditions: Pregnancy Related; Weight Gain; Maternal
• Interventions: Behavioral: SMART Intervention

• Registration Number: NCT05143008
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study Start: 2015-08-13
• Primary Completion: 2017-02-19
• Study Completion: 2017-02-19
• Study First Submitted: 2021-11-18
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMART Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States