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

NCT ID: NCT03053323

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2023-12-01

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle Intervention

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Lifestyle Intervention

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Louisa Grandin Sylvia

Director of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louisa Sylvia, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Marlene Freeman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P002556

Identifier Type: -

Identifier Source: org_study_id