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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Lifestyle Intervention

• 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

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	-

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