Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lifestyle 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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History of depression
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Pregnant in first trimester or planning to become pregnant within next year
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Ability to give informed consent
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Age > or = 18 and < 45 years
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Overweight or obese (Body mass index > 25 kg/m^2)
Exclusion Criteria:
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Unwilling/unable to comply with study procedures
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Endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q)
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Diagnosis of anorexia nervosa or bulimia nervosa in the past month
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Diagnosis of substance dependence in the past month
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Active suicidality (Montgomery Asberg Depression Rating Scale (MADRS) item 10 score >
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Exercising regularly (i.e., 5 days per week for 30 min)
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Neurologic disorder or history of head trauma
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Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Louisa Sylvia, PhD, Massachusetts General Hospital
- Principal Investigator: Marlene Freeman, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016P002556