A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

NCT05143008 | Completed

• 1 other identifier: PRO15060569
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Weight Gain; Maternal

Outcome Measures

Primary Outcomes (3)

• Number of sessions attended among women enrolled in the study

  Number of sessions attended will be calculated for each participant

  Approximately 9 months

• Number of self-monitoring forms returned

  Number of self-monitoring forms returned will be calculated for each participant

  Approximately 9 months

• 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 Outcomes (2)

• Depressive symptoms

  Approximately 12 months

• Perceived stress symptoms

  Approximately 12 months

Study Arms (1)

SMART Intervention

EXPERIMENTAL

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.

Behavioral: SMART Intervention

Interventions

SMART Intervention BEHAVIORAL

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.

SMART Intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Levine, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Each participant will be provided with counseling sessions throughout the course of their pregnancy.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 3, 2021
• Study Start: August 13, 2015
• Primary Completion: February 19, 2017
• Study Completion: February 19, 2017
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)