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

Massachusetts General Hospital24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Lifestyle InterventionBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of treatment measured by participation rates

Participation rates measure attendance at weekly sessions.

Time frame: 10 weeks

Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)

The CSQ-8 is a reliable and valid self-report measure of satisfaction with care and perceived quality and acceptability of treatment.

Time frame: 10 weeks

Secondary Outcomes

Weight loss

Weight will be measured during pre-, mid-, and post-treatment visits.

Time frame: 10 weeks

Exercise duration on the Exercise Questionnaire (EQ)

The EQ assesses baseline exercise history and ongoing exercise duration and frequency.

Time frame: 10 weeks

Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)

The MADRS assesses the presence and severity of patient's current depressive symptoms.

Time frame: 10 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.