Trial Outcomes & Findings for Physical Exercise Influence Among Overweight and Obese Pregnant Women (NCT NCT01136291)

Results Overview

Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

baseline and at 40 gestational weeks

Results posted on

2011-03-23

Participant Flow

A randomized controlled clinical trial was conducted with pregnant women seen at the Prenatal Outpatient Clinic of the Women's Integral Healthcare Center (CAISM-UNICAMP) from August 2008 to August 2010.

The entire study protocol was explained to these women and a written informed consent term was obtained. Subsequently, the women were randomly assigned to two groups: 1) one exercised under supervision and received home exercise counseling (study group) and 2) the other followed the prenatal routine of the service (control group).

Participant milestones

Participant milestones
Measure	Physical Exercise The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Overall Study STARTED	40	42
Overall Study Follow	40	42
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Physical Exercise The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Physical Exercise Influence Among Overweight and Obese Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Exercise n=40 Participants The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise n=42 Participants The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.	Total n=82 Participants Total of all reporting groups
Age Continuous	29.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	30.9 years STANDARD_DEVIATION 5.9 • n=7 Participants	30.1 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	40 participants n=5 Participants	42 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and at 40 gestational weeks

Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy

Outcome measures

Outcome measures
Measure	Physical Exercise n=40 Participants The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise n=42 Participants The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Gestational Weight Gain	10.3 kg Standard Deviation 5.0	11.5 kg Standard Deviation 7.4

PRIMARY outcome

Timeframe: at the 14 to 40 gestational weeks

Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams

Outcome measures

Outcome measures
Measure	Physical Exercise n=40 Participants The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise n=42 Participants The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Weight Gain During the Program	7.7 kg Standard Deviation 4.3	8.1 kg Standard Deviation 4.3

SECONDARY outcome

Timeframe: at the 14 and at the 40 gestational weeks

All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).

Outcome measures

Outcome measures
Measure	Physical Exercise n=40 Participants The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity. The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation. These women also received nutrition and prenatal care.	no Exercise n=42 Participants The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)	49.8 scores on a scale Standard Deviation 17.1	42.2 scores on a scale Standard Deviation 16.1

Adverse Events

Physical Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no 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

Fernanda Garanhani de Castro Surita

Department of Obstetrics and Gynecology - University of Campinas

Phone: +551935219304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place