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Clinical Trials/NCT03053323
NCT03053323
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country24 target enrollmentFebruary 17, 2017
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Massachusetts General Hospital
Enrollment
24
Locations
1
Primary Endpoint
Feasibility of treatment measured by participation rates
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2017
End Date
December 1, 2023
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louisa Grandin Sylvia

Director of Psychology

Massachusetts General Hospital

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)

Outcomes

Primary Outcomes

Feasibility of treatment measured by participation rates

Time Frame: 10 weeks

Participation rates measure attendance at weekly sessions.

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 Outcomes

  • Weight loss(10 weeks)
  • Exercise duration on the Exercise Questionnaire (EQ)(10 weeks)
  • Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)(10 weeks)

Study Sites (1)

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