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

NCT03053323 | Completed

• 1 other identifier: 2016P002556
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Preconception; Pregnancy; Lifestyle

Outcome Measures

Primary Outcomes (2)

• Feasibility of treatment measured by participation rates

  Participation rates measure attendance at weekly sessions.

  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.

  10 weeks

Secondary Outcomes (3)

• Weight loss

  10 weeks

• Exercise duration on the Exercise Questionnaire (EQ)

  10 weeks

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

  10 weeks

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

Behavioral: Lifestyle Intervention

Interventions

Lifestyle Intervention 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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Louisa Sylvia, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Marlene Freeman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychology

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 15, 2017
• Study Start: February 17, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)