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

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Mass General Brigham

Status

Unknown

Conditions

Depression

Treatments

Behavioral: Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03053323
2016P002556

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)

Trial design

24 participants in 1 patient group

Lifestyle Intervention
Experimental group
Treatment:
Behavioral: Lifestyle Intervention

Trial contacts and locations

0

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Central trial contact

Samantha Walsh, BS

Data sourced from clinicaltrials.gov

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