Clinical trial NCT03053323: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Preconception
Pregnancy
Lifestyle
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of treatment measured by participation rates
timeFrame: 10 weeks
measure: Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 10 weeks
Secondary outcomes:
measure: Weight loss
timeFrame: 10 weeks
measure: Exercise duration on the Exercise Questionnaire (EQ)
timeFrame: 10 weeks
measure: Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Louisa Sylvia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Marlene Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References: