Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02756169
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-04-08
Brief Title:
Maternal Obesity and Breastfeeding Performance
Sponsor:
Universidad Iberoamericana AC Mexico
Organization:
Universidad Iberoamericana AC Mexico
Study Overview
Official Title:
Effect of an Immediate-postpartum Support by IBCLC to Women With Obesity on Breastfeeding Performance A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators propose this study in order to answer the following research question An educational intervention and breastfeeding support at postpartum will increase the frequency and total breastfeeding duration in the intervention group This is a randomized with control and intervention groups study open and parallel 1 1 ratio between study groups with 200 pregnant women in the second or third trimester according to their body mass index BMI kg m2 with excess weight BMI 29 pre-pregnancy weight and that will address their pregnancy in the public health services and hospitals belonging to the Health Ministry of 5 districts Coyoacán Magdalena Contreras Tlalpan Xochimilco and Alvaro Obregón in Mexico City
The intervention group and the control group will have the same characteristics for eligibility
The main phases to develop the study are PHASE 1 INTERVENTION DESIGN PHASE 2 IMPLEMENTATION OF THE INTERVENTION PHASE 3 FOLLOW-UP The intervention will be offered at 3 times 1 Educational intervention a workshop to pregnant obese women The workshop will be held by an International Board Certified Lactation Consultant IBCLC to promote exclusive breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO recommendations The workshop will be held at convenient times and will be conducted for groups of 8 to 10 participants 2 Immediate breastfeeding support at hospital by an IBCLC and 3 The women will be exposed to early telephonic follow-up during the first week of their childrens lives and each month until six months of life Then if the breastfeeding continues every two months until the first year of their childrens life
At the first month postpartum investigators will visit participants at home both the control group and the intervention group for collecting information on breastfeeding practices for taking a breast milk sample to estimate its fatty acids content and a blood sample serum to obtain the C-Reactive Protein Also the investigators will take anthropometric measurements of the children to evaluate their growth weight length and skinfold thickness Investigators will ask for breastfeeding practices and diet of the participants through a 24 hours recall
The results of this intervention group will be compared with the control group pregnant obese women without educational intervention or telephonic follow-up
The intervention group and the control group will have the same characteristics for eligibility
The main phases to develop the study are PHASE 1 INTERVENTION DESIGN PHASE 2 IMPLEMENTATION OF THE INTERVENTION PHASE 3 FOLLOW-UP The intervention will be offered at 3 times 1 Educational intervention a workshop to pregnant obese women The workshop will be held by an International Board Certified Lactation Consultant IBCLC to promote exclusive breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO recommendations The workshop will be held at convenient times and will be conducted for groups of 8 to 10 participants 2 Immediate breastfeeding support at hospital by an IBCLC and 3 The women will be exposed to early telephonic follow-up during the first week of their childrens lives and each month until six months of life Then if the breastfeeding continues every two months until the first year of their childrens life
At the first month postpartum investigators will visit participants at home both the control group and the intervention group for collecting information on breastfeeding practices for taking a breast milk sample to estimate its fatty acids content and a blood sample serum to obtain the C-Reactive Protein Also the investigators will take anthropometric measurements of the children to evaluate their growth weight length and skinfold thickness Investigators will ask for breastfeeding practices and diet of the participants through a 24 hours recall
The results of this intervention group will be compared with the control group pregnant obese women without educational intervention or telephonic follow-up
Detailed Description:
BACKGROUND Maternal obesity alters the composition of the breast milk beyond the influence of diet on it Obesity delays copious production of breast milk Lactogenesis stage II and it concurs with the synthesis of prolactin PRL in response to the decreased sucking of the child
Besides that obese mothers have a higher risk of complications in the delivery where it is common to experience great physiological stress and having a high probability of cesarean which metabolically does not interfere with breastfeeding but delays its establishment The excess of subcutaneous fat in the area of the areola of mothers with obesity cause discomfort and stress in the mother and crying in the infant hindering the correct latch of the infant to the nipple weakening the neurological stimulus that triggers Prolactin production
Also obese mothers have reported an increased feeling of insufficient milk compared with non-obese mothers and women with obesity report lower self-efficacy than their pairs without obesity
Despite the implementation of educational interventions to promote the establishment of breastfeeding in obese women the results have not been favorable to increase the prevalence of breastfeeding
To help to improve this practice in women with obesity it raises the following research question
An intervention specifically designed to lessen the problems in establishing breastfeeding in women with obesity which includes an educational intervention with support during the pregnancy the immediate postpartum period and the first year of life increases the frequency of exclusive and predominant breastfeeding during the first month of life and the total duration of breastfeeding
METHODOLOGY PHASE 1 INTERVENTION DESIGN The intervention will be made with information derived from a focus group FG The main objective is to identify the barriers of a mother with obesity for breastfeeding and to explore the ideas to overcome them Investigators will develop a guide to lead the FG discussion
The main characteristic of women participating in the FG is pregnant women with obesity the distinction between primiparous and not primiparous women and those who have breastfed before at least for 6 months
Workshop Design
With an expert on learning techniques as a collaborator investigators will design the workshop with the validated messages derived from the FG and it will be complemented by using the experience of an International Board Certified Lactation Consultant IBCLC The workshop will be divided into three stages
First stage Basics of breastfeeding and its significance for the health of the baby and mother
Second stage discussion of the problems that may arise particularly in mothers with obesity Recommendations and appropriate techniques to solve these problems will be given trough Games and communication activities will be driven
Third stage Treatment of the most common problems and the counseling for solving them
PHASE 2 IMPLEMENTATION OF THE INTERVENTION Step 1 Enrollment This stage is scheduled to take place within 5 months and it has two strategies 1 with previous authorization of the Health Ministry of Mexico City investigators will request information from the censuses of each health jurisdiction where there are all the pregnant women identified or 2 investigators will approach to pregnant women at the time they attend to their medical consultation
Once investigators have identified the pregnant women they will ask for the pregnant women informed consent adult written assent adolescent to obtain information about them since the eligibility criteria will be evaluated
Sociodemographic data and a self-efficacy on breastfeeding questionnaire will be collected Then investigators will assign randomly each one of the women to a study group intervention group or control group
Step 2 Basal phase The assignment to a study group is the beginning of the intervention and it is considered as the baseline of the study
Activities for the Intervention group
The intervention will be set at different times
1 During pregnancy The workshop Also there will be collected another self-efficacy questionnaire at the end
2 At immediate postpartum Investigators will identify the arrival of a woman of the study to any of the five hospitals selected for the study For the intervention group in addition to the collection of data of health conditions of the mother and her baby one of the IBCLC will attend and provide immediate support for the establishment of breastfeeding within the first few hours old of the baby The IBCLC may solve all doubts of the mothers give support supervise and guide the initiation of breastfeeding explain the proper grip suggest the ideal positions to breastfeeding for both the mother and the newborn this support it is supposed to be intensive All these activities must be coordinated with the physicians and nurses from each of the five hospitals in order to follow the rules and requirements that each hospital has established
3 After delivery and until the first year of life of the children the intervention will consist of two steps
1 During the first 7 days of the life of the infant An IBCLC will call the mother daily
2 A telephonic follow-up at 2 weeks old of the baby and then a phone call each month until reaching 6 months then every two months until the baby will have one year of life With the calls investigators pretend to collect information about the duration and type of feeding There is the possibility that the support will be held via Skype if the women prefer it
Activities for both groups intervention and control Investigators will deliver written relevant information about the recommended alimentation of the women at postpartum as well as some ideas for physical activity This technical information is derived from the literature and will be expressed in a simple and accessible way
PHASE 3 FOLLOW-UP At a month postpartum investigators will visit participants at home both the control group and the intervention group for information on breastfeeding practices Also from the mother a breast milk sample will be taken to determine the composition of fatty acids of it a blood sample to determine C-Reactive Protein and also investigators will collect dietary information Additionally weight length and skinfold thickness of the baby will be taken The project staff will be standardized for newborn anthropometric measurement following the technique of Lohman
Sample size and statistical power Investigators will study 200 obese pregnant women 100 per study group This sample size was calculated to detect a difference in the prevalence of exclusive breastfeeding at one month postpartum in 10 percent 12 to 22 with a statistical power of 90 a level of significance 005 a nonresponse rate of 50 and 15 of abandonment postpartum To achieve the sample size recruitment will be held for 5 months hoping to incorporate to the study at least two women daily This calculation was performed using information on the number of women who could meet the inclusion criteria of the study
To achieve this sample size investigators estimated to screen a total of 3700 women in the primary care level health services in order to identify women who meet the inclusion criteria as described above
According to similar studies to calculate the number of women needed to get 200 women 100 in each group investigators did as it follows
All pregnant women attending health centers n 3700 It is expected that at least 34 of women have a body mass index BMI 29 n 1258 It is expected that 40 meet inclusion criteria n 503 Only 50 agree to participate n 251 Approximately 80 give birth in the reference hospital n 200
Data management Study participants will be assigned a unique identification number A subject identification list will be created including the subjects identification number personal information and contact information of each subject participating in the study Only the main investigator will have access to this list in order to make it possible to trace and identify an individual subject This list will also help to carry out medical auditing For all the analysis and data management the identification number will be used in order to ensure confidentiality and privacy of the subjects
Once data is collected by fieldworkers the completed questionnaires will be brought to the headquarters of the study where supervisors will check for potential mistakes or missing information Investigators will use a case report form per participant where a checklist of all information to be collected from them and the quality of it will be recorded The case report form will be filled out by the field supervisor every time is checking the file of each subject The purpose of the case report form will be for monitoring the quality of the information collected and to check that all the information is being collected on time
Data entry will be performed continuously during the course of the study Data will be entered in duplicate for quality control In case there are missing data or errors in data collection the fieldworkers will go back to participants and recover the information when possible Regular backup of databases procedures will be conducted
Statistical processing and analysis
Descriptive statistics summary measures according to variable type and measurement scale including means medians standard errors and variances for each of the stages of data collection baseline and follow-up as applicable To analyze baseline differences between the study groups comparisons between groups will be made by the difference of proportions test for categorical variables and t tests for continuous variables The statistics tests will include design information adjusting the standard errors and applying a continuity correction
For the analysis of sociodemographic information a cluster analysis will be used to identify groups of interest considering some characteristics of women
Analytical or inferential statistics test to be applied by type of variable if necessary statistical hypotheses and test procedures
To evaluate the effect of the intervention data will be analyzed as panel data comparisons of means and variances ANOVA ANCOVA MANOVA and for comparing the groups analysis of variance with and without intervention between and within groups
To evaluate the relationship between obesity and breastfeeding performance investigators will use regression models were conducted and sociodemographic and anthropometric of each of the participants and their children will be included
On the other hand regression models will be conducted to analyze the relationship between the composition of breast milk and the infants growth at one month and at 12 months
All the analysis will be done with intent to treatment
Qualitative analysis For the analysis of the educational intervention qualitative analysis will be carried out through satisfaction surveys and open-ended questionnaires
Besides that obese mothers have a higher risk of complications in the delivery where it is common to experience great physiological stress and having a high probability of cesarean which metabolically does not interfere with breastfeeding but delays its establishment The excess of subcutaneous fat in the area of the areola of mothers with obesity cause discomfort and stress in the mother and crying in the infant hindering the correct latch of the infant to the nipple weakening the neurological stimulus that triggers Prolactin production
Also obese mothers have reported an increased feeling of insufficient milk compared with non-obese mothers and women with obesity report lower self-efficacy than their pairs without obesity
Despite the implementation of educational interventions to promote the establishment of breastfeeding in obese women the results have not been favorable to increase the prevalence of breastfeeding
To help to improve this practice in women with obesity it raises the following research question
An intervention specifically designed to lessen the problems in establishing breastfeeding in women with obesity which includes an educational intervention with support during the pregnancy the immediate postpartum period and the first year of life increases the frequency of exclusive and predominant breastfeeding during the first month of life and the total duration of breastfeeding
METHODOLOGY PHASE 1 INTERVENTION DESIGN The intervention will be made with information derived from a focus group FG The main objective is to identify the barriers of a mother with obesity for breastfeeding and to explore the ideas to overcome them Investigators will develop a guide to lead the FG discussion
The main characteristic of women participating in the FG is pregnant women with obesity the distinction between primiparous and not primiparous women and those who have breastfed before at least for 6 months
Workshop Design
With an expert on learning techniques as a collaborator investigators will design the workshop with the validated messages derived from the FG and it will be complemented by using the experience of an International Board Certified Lactation Consultant IBCLC The workshop will be divided into three stages
First stage Basics of breastfeeding and its significance for the health of the baby and mother
Second stage discussion of the problems that may arise particularly in mothers with obesity Recommendations and appropriate techniques to solve these problems will be given trough Games and communication activities will be driven
Third stage Treatment of the most common problems and the counseling for solving them
PHASE 2 IMPLEMENTATION OF THE INTERVENTION Step 1 Enrollment This stage is scheduled to take place within 5 months and it has two strategies 1 with previous authorization of the Health Ministry of Mexico City investigators will request information from the censuses of each health jurisdiction where there are all the pregnant women identified or 2 investigators will approach to pregnant women at the time they attend to their medical consultation
Once investigators have identified the pregnant women they will ask for the pregnant women informed consent adult written assent adolescent to obtain information about them since the eligibility criteria will be evaluated
Sociodemographic data and a self-efficacy on breastfeeding questionnaire will be collected Then investigators will assign randomly each one of the women to a study group intervention group or control group
Step 2 Basal phase The assignment to a study group is the beginning of the intervention and it is considered as the baseline of the study
Activities for the Intervention group
The intervention will be set at different times
1 During pregnancy The workshop Also there will be collected another self-efficacy questionnaire at the end
2 At immediate postpartum Investigators will identify the arrival of a woman of the study to any of the five hospitals selected for the study For the intervention group in addition to the collection of data of health conditions of the mother and her baby one of the IBCLC will attend and provide immediate support for the establishment of breastfeeding within the first few hours old of the baby The IBCLC may solve all doubts of the mothers give support supervise and guide the initiation of breastfeeding explain the proper grip suggest the ideal positions to breastfeeding for both the mother and the newborn this support it is supposed to be intensive All these activities must be coordinated with the physicians and nurses from each of the five hospitals in order to follow the rules and requirements that each hospital has established
3 After delivery and until the first year of life of the children the intervention will consist of two steps
1 During the first 7 days of the life of the infant An IBCLC will call the mother daily
2 A telephonic follow-up at 2 weeks old of the baby and then a phone call each month until reaching 6 months then every two months until the baby will have one year of life With the calls investigators pretend to collect information about the duration and type of feeding There is the possibility that the support will be held via Skype if the women prefer it
Activities for both groups intervention and control Investigators will deliver written relevant information about the recommended alimentation of the women at postpartum as well as some ideas for physical activity This technical information is derived from the literature and will be expressed in a simple and accessible way
PHASE 3 FOLLOW-UP At a month postpartum investigators will visit participants at home both the control group and the intervention group for information on breastfeeding practices Also from the mother a breast milk sample will be taken to determine the composition of fatty acids of it a blood sample to determine C-Reactive Protein and also investigators will collect dietary information Additionally weight length and skinfold thickness of the baby will be taken The project staff will be standardized for newborn anthropometric measurement following the technique of Lohman
Sample size and statistical power Investigators will study 200 obese pregnant women 100 per study group This sample size was calculated to detect a difference in the prevalence of exclusive breastfeeding at one month postpartum in 10 percent 12 to 22 with a statistical power of 90 a level of significance 005 a nonresponse rate of 50 and 15 of abandonment postpartum To achieve the sample size recruitment will be held for 5 months hoping to incorporate to the study at least two women daily This calculation was performed using information on the number of women who could meet the inclusion criteria of the study
To achieve this sample size investigators estimated to screen a total of 3700 women in the primary care level health services in order to identify women who meet the inclusion criteria as described above
According to similar studies to calculate the number of women needed to get 200 women 100 in each group investigators did as it follows
All pregnant women attending health centers n 3700 It is expected that at least 34 of women have a body mass index BMI 29 n 1258 It is expected that 40 meet inclusion criteria n 503 Only 50 agree to participate n 251 Approximately 80 give birth in the reference hospital n 200
Data management Study participants will be assigned a unique identification number A subject identification list will be created including the subjects identification number personal information and contact information of each subject participating in the study Only the main investigator will have access to this list in order to make it possible to trace and identify an individual subject This list will also help to carry out medical auditing For all the analysis and data management the identification number will be used in order to ensure confidentiality and privacy of the subjects
Once data is collected by fieldworkers the completed questionnaires will be brought to the headquarters of the study where supervisors will check for potential mistakes or missing information Investigators will use a case report form per participant where a checklist of all information to be collected from them and the quality of it will be recorded The case report form will be filled out by the field supervisor every time is checking the file of each subject The purpose of the case report form will be for monitoring the quality of the information collected and to check that all the information is being collected on time
Data entry will be performed continuously during the course of the study Data will be entered in duplicate for quality control In case there are missing data or errors in data collection the fieldworkers will go back to participants and recover the information when possible Regular backup of databases procedures will be conducted
Statistical processing and analysis
Descriptive statistics summary measures according to variable type and measurement scale including means medians standard errors and variances for each of the stages of data collection baseline and follow-up as applicable To analyze baseline differences between the study groups comparisons between groups will be made by the difference of proportions test for categorical variables and t tests for continuous variables The statistics tests will include design information adjusting the standard errors and applying a continuity correction
For the analysis of sociodemographic information a cluster analysis will be used to identify groups of interest considering some characteristics of women
Analytical or inferential statistics test to be applied by type of variable if necessary statistical hypotheses and test procedures
To evaluate the effect of the intervention data will be analyzed as panel data comparisons of means and variances ANOVA ANCOVA MANOVA and for comparing the groups analysis of variance with and without intervention between and within groups
To evaluate the relationship between obesity and breastfeeding performance investigators will use regression models were conducted and sociodemographic and anthropometric of each of the participants and their children will be included
On the other hand regression models will be conducted to analyze the relationship between the composition of breast milk and the infants growth at one month and at 12 months
All the analysis will be done with intent to treatment
Qualitative analysis For the analysis of the educational intervention qualitative analysis will be carried out through satisfaction surveys and open-ended questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SSASEDESA1010100116 | OTHER | Ministry of Health of Mexico | None |