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Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03053323
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : March 6, 2019
Information provided by (Responsible Party):
Louisa Grandin Sylvia, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Lifestyle Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle Intervention Behavioral: Lifestyle Intervention
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 Measures :
  1. Feasibility of treatment measured by participation rates [ Time Frame: 10 weeks ]
    Participation rates measure attendance at weekly sessions.

  2. Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 10 weeks ]
    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 :
  1. Weight loss [ Time Frame: 10 weeks ]
    Weight will be measured during pre-, mid-, and post-treatment visits.

  2. Exercise duration on the Exercise Questionnaire (EQ) [ Time Frame: 10 weeks ]
    The EQ assesses baseline exercise history and ongoing exercise duration and frequency.

  3. Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 10 weeks ]
    The MADRS assesses the presence and severity of patient's current depressive symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03053323

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Contact: Samantha Walsh, BS 617-643-2076

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Samantha Walsh, BS    617-643-2076   
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Louisa Sylvia, PhD Massachusetts General Hospital
Principal Investigator: Marlene Freeman, MD Massachusetts General Hospital

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Responsible Party: Louisa Grandin Sylvia, Director of Psychology, Massachusetts General Hospital Identifier: NCT03053323     History of Changes
Other Study ID Numbers: 2016P002556
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Louisa Grandin Sylvia, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders