Effect of Exercise on Perinatal Depression

NCT02791932 | Completed

• 1 other identifier: R40MC29454
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Postpartum Period; Depression

Keywords

Pregnancy; Postpartum period; Depression

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale

  Change from baseline to 3 months postpartum

Secondary Outcomes (1)

• Postpartum Weight Retention

  Change from baseline to 3 months postpartum

Study Arms (2)

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.

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.

Interventions

Exercise BEHAVIORAL

See description above.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Beth Lewis

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 7, 2016
• Study Start: February 23, 2017
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

US (1)