Trial Outcomes & Findings for The Effect of Exercise on Preventing PostPartum Depression (NCT NCT00961402)

Last Updated: 2019-11-18

Results Overview

This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

6 months

Results posted on

2019-11-18

Participant Flow

Recruitment occurred from January, 2010 through May, 2011 and follow-up assessments were completed by November, 2011. Participants were recruited via advertisements to the general public.

The major reason for why participants who consented but did not participate was that they failed to return our telephone calls after they had their baby or we were unable to obtain physician consent for them to participate.

Participant milestones

Participant milestones
Measure	Wellness Control Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control
Overall Study STARTED	64	66
Overall Study Randomized	64	66
Overall Study COMPLETED	63	61
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Exercise on Preventing PostPartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wellness Control n=64 Participants Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise n=66 Participants Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control	Total n=130 Participants Total of all reporting groups
Age, Continuous	31.39 years STANDARD_DEVIATION 4.63 • n=5 Participants	31.69 years STANDARD_DEVIATION 5.27 • n=7 Participants	31.54 years STANDARD_DEVIATION 4.95 • n=5 Participants
Sex/Gender, Customized Females	64 participants n=5 Participants	66 participants n=7 Participants	130 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	64 Participants n=7 Participants	125 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	66 participants n=7 Participants	130 participants n=5 Participants
Perceived Stress Scale	24.73 units on a scale STANDARD_DEVIATION 6.98 • n=5 Participants	23.21 units on a scale STANDARD_DEVIATION 7.94 • n=7 Participants	23.96 units on a scale STANDARD_DEVIATION 7.50 • n=5 Participants
Patient Health Questionnaire (PHQ-9)	6.56 units on a scale STANDARD_DEVIATION 4.27 • n=5 Participants	5.42 units on a scale STANDARD_DEVIATION 3.28 • n=7 Participants	5.99 units on a scale STANDARD_DEVIATION 3.83 • n=5 Participants
Pittsburgh Sleep Quality Index	7.11 units on a scale STANDARD_DEVIATION 3.08 • n=5 Participants	7.11 units on a scale STANDARD_DEVIATION 2.61 • n=7 Participants	7.11 units on a scale STANDARD_DEVIATION 2.84 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Wellness Control n=63 Participants Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise n=61 Participants Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control
Structured Clinical Interview for DSM-IV Axis I Disorders	7.94 percentage of participants	8.20 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).

Outcome measures

Outcome measures
Measure	Wellness Control n=63 Participants Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise n=61 Participants Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control
7-Day Physical Activity Recall Interview	123.3 Number of physical activity minutes Standard Deviation 111.4	129.8 Number of physical activity minutes Standard Deviation 87.5

SECONDARY outcome

Timeframe: 6 Months

This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.

Outcome measures

Outcome measures
Measure	Wellness Control n=63 Participants Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise n=61 Participants Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control
Edinburgh Postnatal Depression Scale	7.02 Score on a scale Standard Deviation 4.64	4.69 Score on a scale Standard Deviation 3.89

SECONDARY outcome

Timeframe: 6 Months

Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression

Outcome measures

Outcome measures
Measure	Wellness Control n=63 Participants Participants will receive health and wellness information and no exercise information. Exercise: 6-month exercise intervention vs. wellness control	Exercise n=61 Participants Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session. Exercise: 6-month exercise intervention vs. wellness control
PHQ-9	5.22 Score on a scale Standard Deviation 4.59	3.08 Score on a scale Standard Deviation 3.04

Adverse Events

Wellness Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Lewis

University of Minnesota

Phone: 612-625-0756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place