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

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    24
  • sponsor
    Massachusetts General Hospital
Updated on 25 February 2022
body mass index
depressed mood

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.

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.

Details
Condition Depression
Treatment Lifestyle intervention
Clinical Study IdentifierNCT03053323
SponsorMassachusetts General Hospital
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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