Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
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|ClinicalTrials.gov Identifier: NCT03053323|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression|
|Actual Study Start Date :||February 17, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|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.
- Feasibility of treatment measured by participation rates [ Time Frame: 10 weeks ]Participation rates measure attendance at weekly sessions.
- 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.
- Weight loss [ Time Frame: 10 weeks ]Weight will be measured during pre-, mid-, and post-treatment visits.
- Exercise duration on the Exercise Questionnaire (EQ) [ Time Frame: 10 weeks ]The EQ assesses baseline exercise history and ongoing exercise duration and frequency.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053323
|Contact: Samantha Walsh, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Samantha Walsh, BS 617-643-2076 email@example.com|
|Principal Investigator:||Louisa Sylvia, PhD||Massachusetts General Hospital|
|Principal Investigator:||Marlene Freeman, MD||Massachusetts General Hospital|