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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br> | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight will be measured during pre-, mid-, and post-treatment visits. | 10 weeks | 
| Exercise duration on the Exercise Questionnaire (EQ) | The EQ assesses baseline exercise history and ongoing exercise duration and frequency. | 10 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preconception, Pregnancy, Lifestyle