PregnancyNCT02791932
Effect of Exercise on Perinatal Depression
A study testing Exercise in people with Pregnancy and Postpartum Period, run by University of Minnesota at 1 site in United States.
Trial summary
Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Postpartum Period, Depression
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 15 Jun 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- less than 20 weeks pregnant
- must speak English or Spanish
- willing to be randomly assigned to either of the two study arms
- healthcare provider consent
- access to a telephone (92% of low income women have access to a telephone and Minnesota offers free phone access for low income individuals; Fasts, 2015)
- being at risk for depression (defined as having a history of depression) but are not currently depressed.
- consistent with prior research, history of depression will be defined as ever being told by a healthcare provider that she has depression and/or being prescribed an antidepressant for depression.
Who cannot join
- less than 18 years of age
- currently exercising 60 or more minutes per week
- unable to exercise for 20 minutes continuously
- history of heart disease, lung disease, anemia, musculoskeletal problems (e.g., arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising), poorly controlled hypertension, seizure disorder, exercise induced asthma, or any other medical condition that would make exercise unsafe
- taking medication that interferes with heart rate responses to exercise such as beta blockers; participating in another exercise or weight management study
- another member of the household participating in the study
Show all 10Show fewer
- currently receiving antidepressant medication or psychotherapy for depression; - hospitalization for a psychiatric disorder during previous six months
- pregnant with multiple fetuses.
- participants depressed at the baseline assessment will be referred to their healthcare provider.
- there will have a safety protocol in place for worsening symptoms of depression and suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intervention for Preventing Perinatal Depression
Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Given few women with perinatal depression seek treatment, there is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women.
Read the detailed description
Approximately 15% of women experience perinatal depression (depression during pregnancy or postpartum). Furthermore, 38% of low income women experience postpartum depression (Gree-Smith et al., 2012). Perinatal depression is associated with numerous maternal (e.g., weight retention), infant (e.g., poor infant-child bond), and lifespan (e.g., behavior problems) consequences (Barker et al., 2011, Herring et al., 2008, Hipwell et al., 2000). Psychosocial interventions are efficacious for perinatal depression; however, only 10% of women seek treatment (Oppo et al., 2009). There is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). Preliminary evidence indicates that exercise may be a novel, efficacious intervention. The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women. Possible effects on gestational weight gain and retention will also be explored. This study will build upon the study team's previous work by recruiting low income women and integrating the intervention with community-based clinics. Participants (n=200) who are low income and pregnant (less than 20 weeks) will be randomly assigned to either a telephone-based intervention that has been previously shown to increase exercise among perinatal women (Lewis et al., 2011) or usual care.
With regard to the primary aim, the investigators predict that participants randomized to the exercise intervention will report fewer depressive symptoms (as measured by Edinburgh Postnatal Depression Scale) at 36 weeks gestation and three months postpartum than women in the usual care condition. The secondary aim is to examine the efficacy of an exercise intervention on moderating prenatal weight gain and facilitating postpartum weight loss. The investigators will also examine several potential mediators (e.g., depression coping, self-efficacy, perceived stress, sleep, fatigue) and the effect of the exercise intervention on maternal (e.g., hypertension, gestational diabetes, mode of delivery) and infant outcomes (e.g., birth weight, gestational age at delivery, breastfeeding, safe sleep).
- Conditions
- Pregnancy, Postpartum Period, Depression
- Being tested
- Exercise
- Keywords
- Pregnancy, Postpartum period, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
See description above.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The intervention will last 8-10 months depending on when during pregnancy the participant is randomized. The intervention will consist of three components (i.e., telephone, print materials, and exercise log/goal setting) designed to increase exercise. Social Cognitive Theory (SCT) and Self-Determination Theory will guide the exercise intervention. The counseling sessions will be a collaboration between the counselor and participants on how to best integrate exercise into the participant's daily routine. Participants will receive 15 intervention phone calls lasting approximately 15-20 minutes each. There will be a one-month intensive phase (weekly contacts), followed by bi-weekly contacts for two months, and then monthly until delivery. Beginning at 6 weeks postpartum, bi-weekly contacts will resume through 3 months postpartum. Receives: Behavioral: Exercise |
| Usual Care | No intervention | Participants in the usual care condition will follow their usual standard of care as suggested by their healthcare provider. Participants will complete the same assessments and incentives as the active interventions but will not receive the exercise counseling sessions. Following completion of the nine-month follow-up, the usual care arm can choose to receive a six-month version of the exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
Measured: Change from baseline to 3 months postpartum
Secondary outcomes (1)
Postpartum Weight Retention
Measured: Change from baseline to 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start23 Feb 2017
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791932
- Sponsor's protocol ID
- R40MC29454
- Status last verified
- Jan 2021
- First submitted
- 27 May 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention for Preventing Perinatal Depression
- ClinicalTrials.gov ID
- NCT02791932
- Acronym / sponsor ID
- R40MC29454
- Conditions
- Pregnancy, Postpartum Period, Depression
- Keywords
- Pregnancy, Postpartum period, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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.
Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Given few women with perinatal depression seek treatment, there is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women.
Detailed description
Approximately 15% of women experience perinatal depression (depression during pregnancy or postpartum). Furthermore, 38% of low income women experience postpartum depression (Gree-Smith et al., 2012). Perinatal depression is associated with numerous maternal (e.g., weight retention), infant (e.g., poor infant-child bond), and lifespan (e.g., behavior problems) consequences (Barker et al., 2011, Herring et al., 2008, Hipwell et al., 2000). Psychosocial interventions are efficacious for perinatal depression; however, only 10% of women seek treatment (Oppo et al., 2009). There is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). Preliminary evidence indicates that exercise may be a novel, efficacious intervention. The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women. Possible effects on gestational weight gain and retention will also be explored. This study will build upon the study team's previous work by recruiting low income women and integrating the intervention with community-based clinics. Participants (n=200) who are low income and pregnant (less than 20 weeks) will be randomly assigned to either a telephone-based intervention that has been previously shown to increase exercise among perinatal women (Lewis et al., 2011) or usual care.
With regard to the primary aim, the investigators predict that participants randomized to the exercise intervention will report fewer depressive symptoms (as measured by Edinburgh Postnatal Depression Scale) at 36 weeks gestation and three months postpartum than women in the usual care condition. The secondary aim is to examine the efficacy of an exercise intervention on moderating prenatal weight gain and facilitating postpartum weight loss. The investigators will also examine several potential mediators (e.g., depression coping, self-efficacy, perceived stress, sleep, fatigue) and the effect of the exercise intervention on maternal (e.g., hypertension, gestational diabetes, mode of delivery) and infant outcomes (e.g., birth weight, gestational age at delivery, breastfeeding, safe sleep).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThe intervention will last 8-10 months depending on when during pregnancy the participant is randomized. The intervention will consist of three components (i.e., telephone, print materials, and exercise log/goal setting) designed to increase exercise. Social Cognitive Theory (SCT) and Self-Determination Theory will guide the exercise intervention. The counseling sessions will be a collaboration between the counselor and participants on how to best integrate exercise into the participant's daily routine. Participants will receive 15 intervention phone calls lasting approximately 15-20 minutes each. There will be a one-month intensive phase (weekly contacts), followed by bi-weekly contacts for two months, and then monthly until delivery. Beginning at 6 weeks postpartum, bi-weekly contacts will resume through 3 months postpartum. |
| Usual Care | No intervention | –Participants in the usual care condition will follow their usual standard of care as suggested by their healthcare provider. Participants will complete the same assessments and incentives as the active interventions but will not receive the exercise counseling sessions. Following completion of the nine-month follow-up, the usual care arm can choose to receive a six-month version of the exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- less than 20 weeks pregnant
- must speak English or Spanish
- willing to be randomly assigned to either of the two study arms
- healthcare provider consent
- access to a telephone (92% of low income women have access to a telephone and Minnesota offers free phone access for low income individuals; Fasts, 2015)
Key exclusion criteria (10 listed)
- less than 18 years of age
- currently exercising 60 or more minutes per week
- unable to exercise for 20 minutes continuously
- history of heart disease, lung disease, anemia, musculoskeletal problems (e.g., arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising), poorly controlled hypertension, seizure disorder, exercise induced asthma, or any other medical condition that would make exercise unsafe
- taking medication that interferes with heart rate responses to exercise such as beta blockers; participating in another exercise or weight management study
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 |
|---|---|---|
| ExerciseSee description above. | Behavioural | Exercise |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: Change from baseline to 3 months postpartum
1 secondary outcome
Postpartum Weight Retention
Time frame: Change from baseline to 3 months postpartum
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 13 Jan 2021.
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pregnancy and Postpartum Period, run by University of Minnesota 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 7 inclusion and 10 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 13 Jan 2021. 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?
Edinburgh Postnatal Depression Scale (time frame: Change from baseline to 3 months postpartum). 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 13 Jan 2021.