Overweight and Obesity
Conditions
Brief summary
The purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or more.
Detailed description
This pilot study seeks to determine if formula feeding recommendations that are calibrated using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants. Calibrated formula feeding refers to adjusting the recommended daily caloric formula intake to account for weight status. A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care. Intervention group parents will also be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. The investigators hypothesize that the calibrated formula intake intervention will reduce rapid infant gain and overweight during infancy resulting in lower weight-for-length at age 6 months.
Interventions
BEHAVIORALIntervention
Provided with educational materials, guidelines and instructions.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care.
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Term or Early Term (≥37 weeks), singleton infants * Infant birthweight ≥50th percentile based on the 2013 Fenton Growth Charts (which account for sex of child and gestational age at birth) * Infant without substantial neonatal morbidity that would affect feeding or weight gain (e.g. known chromosomal abnormality, metabolic disorder, cleft lip/palate, etc.) * Infant age ≤1 month * Mothers with pre-pregnancy body mass index ≥25 kg/m2 * Mothers ≥18 years old * Parental plan to exclusively feed infant 19-20 kcal/ounce formula upon delivery or by the start of the intervention period \ 1 month after delivery * Parental intention to have infant well child visits through age 6 months at a Division of Academic General Pediatrics practice site (Hope Drive, Elizabethtown, Nyes Road) * English speaking parent
Exclusion criteria
* Infants who weigh less than their birthweight 21 days after delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditional Weight Gain Difference Between Study Groups | Between birth and 6 months | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conditional Weight Gain Difference Between Study Groups | During the intervention period spanning Ages 1-6 Months | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. |
| Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards | 1 time point at age 6 Months | Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean |
| Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period | Spanning ages 1-6 months | repeated measures analysis of weight-for-length |
| Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) | 1 time point at age 6 months | % overweight by study group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria | 29 |
| Control The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 29 Participants | 31 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 27 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 12 / 29 | 13 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Conditional Weight Gain Difference Between Study Groups
Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.
Time frame: Between birth and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Conditional Weight Gain Difference Between Study Groups | 0.27 Conditional Weight Gain score |
| Control | Conditional Weight Gain Difference Between Study Groups | -0.12 Conditional Weight Gain score |
Secondary
Conditional Weight Gain Difference Between Study Groups
Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.
Time frame: During the intervention period spanning Ages 1-6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Conditional Weight Gain Difference Between Study Groups | 0.28 Conditional weight gain score |
| Control | Conditional Weight Gain Difference Between Study Groups | -0.14 Conditional weight gain score |
Secondary
Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period
repeated measures analysis of weight-for-length
Time frame: Spanning ages 1-6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period | 12.4 kg/m |
| Control | Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period | 12.1 kg/m |
Secondary
Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards
Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean
Time frame: 1 time point at age 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards | 0.73 Z-score |
| Control | Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards | 0.65 Z-score |
Secondary
Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)
% overweight by study group
Time frame: 1 time point at age 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) | 4 Participants |
| Control | Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) | 2 Participants |