A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

University of Pittsburgh

Status: Completed

Conditions: Maternal; Weight Gain; Pregnancy Related

Treatments: Behavioral: SMART Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05143008

PRO15060569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

SMART Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: SMART Intervention