Trial Outcomes & Findings for Walking and Dietary Modification for Recurrent Early Miscarriages (NCT NCT03023137)

NCT ID: NCT03023137

Last Updated: 2017-04-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 480 participants
• Primary outcome timeframe: End of pregnancy
• Results posted on: 2017-04-10

Participant Flow

Recruitment started on May 2011 and was stopped on April 2015.

Of 491 patients approached, 11 declined participation in the study and 480 were enrolled. Participants in the W+D arm were recommended lifestyle changes to be started when they wished to conceive. Only participants in both groups who managed to get pregnant were included in the study.

Participant milestones

Measure	Walking & Dietary Modification (W&D) The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Overall Study STARTED	178	171
Overall Study COMPLETED	174	162
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Measure	Walking & Dietary Modification (W&D) The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Overall Study Multiple pregnancy	2	4
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	0	4
Overall Study Lost the baby in a car accident	1	0

Baseline Characteristics

Walking and Dietary Modification for Recurrent Early Miscarriages

Baseline characteristics by cohort

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrolment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.	Total n=336 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 7 • n=5 Participants	30 years STANDARD_DEVIATION 8 • n=7 Participants	30 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	162 Participants n=7 Participants	336 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	72 Participants n=5 Participants	62 Participants n=7 Participants	134 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	87 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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 Brazil	174 participants n=5 Participants	162 participants n=7 Participants	336 participants n=5 Participants
Normal or underweight (BMI <25 kg/m2)	105 participants n=5 Participants	95 participants n=7 Participants	200 participants n=5 Participants
Owerweight (BMI 25-30 kg/m2)	53 participants n=5 Participants	48 participants n=7 Participants	101 participants n=5 Participants
Obese (BMI > 30 kg/m2)	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants
Type 1 diabetes mellitus	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Chronic hypertension	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants
Women with live offspring	36 participants n=5 Participants	28 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: End of pregnancy

Population: Since we excluded multiple gestations, there were 174 single pregnancies in group W\&D and 162 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Take-home Baby Rate	152 babies	83 babies

SECONDARY outcome

Timeframe: Pregnancies reaching 24 weeks' gestation

Population: A total of 154 pregnancies in group W\&D and 98 pregnancies in the control group reached 24 weeks of gestation.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=154 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=98 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Gestational Diabetes Mellitus	4 mothers	17 mothers

SECONDARY outcome

Timeframe: Pregnancies reaching 20 weeks' gestation

Population: A total of 154 pregnancies reached 20 weeks in group W\&D and 98 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=154 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=98 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Preeclampsia	8 mothers	22 mothers

SECONDARY outcome

Timeframe: End of pregnancy

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency	10 mothers	30 mothers

SECONDARY outcome

Timeframe: End of term pregnancies

Population: A total of 148 pregnancies in group W\&D and 57 pregnancies in the control group reached term.

Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=148 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=57 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Excessive Weight Gain	12 mothers	21 mothers

SECONDARY outcome

Timeframe: 14 weeks of gestation

Population: Since we excluded multiple gestations, there were 174 single pregnancies in group W\&D and 162 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
First-trimester Losses	21 embryos	63 embryos

SECONDARY outcome

Timeframe: 28 weeks of gestation and end of gestation

Population: Since we excluded multiple gestations, there were 174 single pregnancies in group W\&D and 162 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Second and Third-trimester Losses	0 fetuses	7 fetuses

SECONDARY outcome

Timeframe: End of pregnancy

Population: A total of 153 babies were born alive in group W\&D and 91 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=174 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=162 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Live-born Children	153 babies	91 babies

SECONDARY outcome

Timeframe: End of pregnancy

Population: A total of 153 babies were born alive in group W\&D and 91 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=153 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=91 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Babies Born at Term	138 babies	57 babies

SECONDARY outcome

Timeframe: End of pregnancy

Population: A total of 153 babies were born alive in group W\&D and 91 in the control group.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=153 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=91 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Appropriate-for-gestational Age Babies	141 babies	56 babies

SECONDARY outcome

Timeframe: One, two and fours hours after birth

Population: A total of 153 babies were born alive in group W\&D and 91 in the control group.

Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.

Outcome measures

Measure	Walking & Dietary Modification (W&D) n=153 Participants The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=91 Participants No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Neonates With Hypoglycemia	3 babies	15 babies

Adverse Events

Walking & Dietary Modification (W&D)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Walking & Dietary Modification (W&D) n=245 participants at risk The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W\&D at enrollment and at each consultation. Walking \& dietary modification: 1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term. 2\. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention	Controls n=255 participants at risk No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
Musculoskeletal and connective tissue disorders Bone and joint injury	0.41% 1/245 • Throughout pregnancy	0.00% 0/255 • Throughout pregnancy

Additional Information

Dr. Silvia Hoirisch-Clapauch

Hospital Federal dos Servidores do Estado

Phone: 5521999737500

Email: sclapauch@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place