Back to resultsPreconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Preconception, Pregnancy, Lifestyle
Eligibility Criteria
Inclusion Criteria:
- History of depression
- Pregnant in first trimester or planning to become pregnant within next year
- Ability to give informed consent
- Age > or = 18 and < 45 years
- Overweight or obese (Body mass index > 25 kg/m^2)
Exclusion Criteria:
- Unwilling/unable to comply with study procedures
- Endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q)
- Diagnosis of anorexia nervosa or bulimia nervosa in the past month
- Diagnosis of substance dependence in the past month
- Active suicidality (Montgomery Asberg Depression Rating Scale (MADRS) item 10 score > 4)
- Exercising regularly (i.e., 5 days per week for 30 min)
- Neurologic disorder or history of head trauma
- Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle Intervention
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of treatment measured by participation rates
Participation rates measure attendance at weekly sessions.
Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is a reliable and valid self-report measure of satisfaction with care and perceived quality and acceptability of treatment.
Secondary Outcome Measures
Weight loss
Weight will be measured during pre-, mid-, and post-treatment visits.
Exercise duration on the Exercise Questionnaire (EQ)
The EQ assesses baseline exercise history and ongoing exercise duration and frequency.
Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS assesses the presence and severity of patient's current depressive symptoms.
Full Information
NCT ID
NCT03053323
First Posted
February 8, 2017
Last Updated
February 18, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03053323
Brief Title
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Official Title
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
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 the Preconception and Pregnancy Obesity Treatment and Prevention Among Women with A History of Depression preliminary study is to provide a lifestyle intervention for women with a history of depression who are trying to conceive or are pregnant in order to prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to improve other markers of metabolic health. The treatment program consists of 10 private sessions with a trained clinician at no cost to participants.
Detailed Description
The investigators are evaluating a new lifestyle intervention to help women with a history of depression who are pregnant or trying to conceive to learn to exercise, eat well, and live a healthy lifestyle. They are interested in examining if this therapy-based program can positively impact eating and exercising habits and see if the treatment is enjoyable. All participants will receive this intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Preconception, Pregnancy, Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
The lifestyle intervention consists of three components: nutrition, physical activity, and other areas of wellness. The intervention is administered individually each week for 10 weeks and is tailored for women with a history of depression who are in the first trimester of pregnancy or trying to conceive.
Primary Outcome Measure Information:
Title
Feasibility of treatment measured by participation rates
Description
Participation rates measure attendance at weekly sessions.
Time Frame
10 weeks
Title
Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)
Description
The CSQ-8 is a reliable and valid self-report measure of satisfaction with care and perceived quality and acceptability of treatment.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Weight loss
Description
Weight will be measured during pre-, mid-, and post-treatment visits.
Time Frame
10 weeks
Title
Exercise duration on the Exercise Questionnaire (EQ)
Description
The EQ assesses baseline exercise history and ongoing exercise duration and frequency.
Time Frame
10 weeks
Title
Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
The MADRS assesses the presence and severity of patient's current depressive symptoms.
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of depression
Pregnant in first trimester or planning to become pregnant within next year
Ability to give informed consent
Age > or = 18 and < 45 years
Overweight or obese (Body mass index > 25 kg/m^2)
Exclusion Criteria:
Unwilling/unable to comply with study procedures
Endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q)
Diagnosis of anorexia nervosa or bulimia nervosa in the past month
Diagnosis of substance dependence in the past month
Active suicidality (Montgomery Asberg Depression Rating Scale (MADRS) item 10 score > 4)
Exercising regularly (i.e., 5 days per week for 30 min)
Neurologic disorder or history of head trauma
Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Walsh, BS
Phone
617-643-2076
Email
swalsh28@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa Sylvia, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marlene Freeman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Walsh, BS
Phone
617-643-2076
Email
swalsh28@partners.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
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