DepressionNCT03053323
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
A study testing Lifestyle Intervention in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Lifestyle Intervention
- Keywords
- Preconception, Pregnancy, Lifestyle
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Not described Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of treatment measured by participation rates
Participation rates measure attendance at weekly sessions.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (3)
Weight loss
Weight will be measured during pre-, mid-, and post-treatment visits.
Measured: 10 weeks
Exercise duration on the Exercise Questionnaire (EQ)
The EQ assesses baseline exercise history and ongoing exercise duration and frequency.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start17 Feb 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louisa Grandin Sylvia, Massachusetts General Hospital
- Investigators
- Louisa Sylvia, PhD, Principal investigator, Massachusetts General HospitalMarlene Freeman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053323
- Sponsor's protocol ID
- 2016P002556
- Status last verified
- May 2025
- First submitted
- 8 Feb 2017
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
- ClinicalTrials.gov ID
- NCT03053323
- Acronym / sponsor ID
- 2016P002556
- Conditions
- Depression
- Keywords
- Preconception, Pregnancy, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle Intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe 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. | Behavioural | Lifestyle Intervention |
Primary outcome
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.
3 secondary outcomes
Weight loss
Time frame: 10 weeks
Exercise duration on the Exercise Questionnaire (EQ)
Time frame: 10 weeks
Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Sylvia, PhD principal investigator
Massachusetts General Hospital
Marlene Freeman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of treatment measured by participation rates (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.