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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053323
• Other study ID #: 2016P002556
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: December 2022

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: Samantha Walsh, BS
• Phone: 617-643-2076
• Email: swalsh28[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of treatment measured by participation rates	Participation rates measure attendance at weekly sessions.	10 weeks
Primary	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.	10 weeks
Secondary	Weight loss	Weight will be measured during pre-, mid-, and post-treatment visits.	10 weeks
Secondary	Exercise duration on the Exercise Questionnaire (EQ)	The EQ assesses baseline exercise history and ongoing exercise duration and frequency.	10 weeks
Secondary	Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)	The MADRS assesses the presence and severity of patient's current depressive symptoms.	10 weeks