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Completed

NCT Number: NCT05143008

A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

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.

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Key information

Conditions

Pregnancy Related Body Weight Body Weight Changes Maternal Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Number of self-monitoring forms returned

    Time frame: Approximately 9 months

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

  3. 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

  1. Depressive symptoms

    Time frame: 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.

  2. Perceived stress symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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