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Completed

NCT Number: NCT03053323

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of treatment measured by participation rates

    Time frame: 10 weeks

    Participation rates measure attendance at weekly sessions.

  2. Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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 outcomes

  1. Weight loss

    Time frame: 10 weeks

    Weight will be measured during pre-, mid-, and post-treatment visits.

  2. Exercise duration on the Exercise Questionnaire (EQ)

    Time frame: 10 weeks

    The EQ assesses baseline exercise history and ongoing exercise duration and frequency.

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

    Time frame: 10 weeks

    The MADRS assesses the presence and severity of patient's current depressive symptoms.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Feb 15, 2017
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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