Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louisa Sylvia, PhD | Massachusetts General Hospital | Principal Investigator |
| Marlene Freeman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |