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A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

NCT ID: NCT05143008

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-13

Study Completion Date

2017-02-19

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Weight Gain Maternal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each participant will be provided with counseling sessions throughout the course of their pregnancy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMART Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Michele Levine

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Levine, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO15060569

Identifier Type: -

Identifier Source: org_study_id