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

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT03053323
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-15
• Study Start: 2017-02-17
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of treatment measured by participation rates	10 weeks	Participation rates measure attendance at weekly sessions.
Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)	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 Outcome Measures

Name	Time	Method
Weight loss	10 weeks	Weight will be measured during pre-, mid-, and post-treatment visits.
Exercise duration on the Exercise Questionnaire (EQ)	10 weeks	The EQ assesses baseline exercise history and ongoing exercise duration and frequency.
Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)	10 weeks	The MADRS assesses the presence and severity of patient's current depressive symptoms.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States