Back to resultsA Pilot Study to Evaluate an Intervention for Gestational Weight Gain
Primary Purpose
Pregnancy Related, Weight Gain, Maternal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMART Intervention
Arm 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.
Outcomes
Primary Outcome Measures
Number of sessions attended among women enrolled in the study
Number of sessions attended will be calculated for each participant
Number of self-monitoring forms returned
Number of self-monitoring forms returned will be calculated for each participant
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.
Secondary Outcome Measures
Depressive symptoms
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
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.
Full Information
NCT ID
NCT05143008
First Posted
November 18, 2021
Last Updated
December 2, 2021
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05143008
Brief Title
A Pilot Study to Evaluate an Intervention for Gestational Weight Gain
Official Title
Strategies for Self-Management Around the Reproductive Transition: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2015 (Actual)
Primary Completion Date
February 19, 2017 (Actual)
Study Completion Date
February 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Weight Gain, Maternal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant will be provided with counseling sessions throughout the course of their pregnancy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
SMART Intervention
Intervention Description
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 Outcome Measure Information:
Title
Number of sessions attended among women enrolled in the study
Description
Number of sessions attended will be calculated for each participant
Time Frame
Approximately 9 months
Title
Number of self-monitoring forms returned
Description
Number of self-monitoring forms returned will be calculated for each participant
Time Frame
Approximately 9 months
Title
Gestational weight gain
Description
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.
Time Frame
Approximately 9 months
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
Approximately 12 months
Title
Perceived stress symptoms
Description
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.
Time Frame
Approximately 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Levine, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study to Evaluate an Intervention for Gestational Weight Gain
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