Maternal BehaviorRIFNCT02893319
Maternal and Infant Growth Study
A study testing Feeding and growth differences, 5oz vs 8oz bottle in people with Maternal Behavior and Body Weight, run by Leann Birch.
Trial summary
Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Body Weight, Infant Behavior
- What is being tested?
- Feeding and growth differences, 5oz vs 8oz bottle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant or newborn aged 28 days or younger
Who cannot join
- gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight
About this study
Official title: Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)
Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.
Read the detailed description
Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.
- Conditions
- Maternal Behavior, Body Weight, Infant Behavior
- Being tested
- Feeding and growth differences, 5oz vs 8oz bottle
- Keywords
- Infant Feeding, Infant Growth
- Medical subject headings
- Body Weight, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding and growth differences, 5oz vs 8oz bottleBehavioural
Group A: 5oz bottle Group B: 8oz bottle
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding | No intervention | control group |
| 5 oz bottle | Active comparator | Subject will feed infant with 5oz medela bottle Receives: Behavioral: Feeding and growth differences, 5oz vs 8oz bottle |
| 8 oz bottle | Active comparator | Subject will feed infant with 8oz medela bottle Receives: Behavioral: Feeding and growth differences, 5oz vs 8oz bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant Weight-for-Age Z-score over time by group
Infant weight (kg) (PEA POD scale) will be measured at each of three time points (2, 8, 16 weeks of age). Weight-for-Age Z-score (WAZ) will be calculated based on World Health Organization Global Database on Child Growth, means will be calculated and compared.
Measured: 2, 8 and 16 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leann Birch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leann Birch, University of Georgia
- Investigators
- Leann L Birch, PhD, Principal investigator, The University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893319
- Sponsor's protocol ID
- 2013102510
- Acronym
- RIF
- Status last verified
- Oct 2018
- First submitted
- 24 Aug 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All data is de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)
- ClinicalTrials.gov ID
- NCT02893319
- Acronym / sponsor ID
- RIF / 2013102510
- Conditions
- Maternal Behavior, Body Weight, Infant Behavior
- Keywords
- Infant Feeding, Infant Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Leann BirchUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.
Detailed description
Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding | No intervention | –control group |
| 5 oz bottle | Active comparator | Behavioral: Feeding and growth differences, 5oz vs 8oz bottleSubject will feed infant with 5oz medela bottle |
| 8 oz bottle | Active comparator | Behavioral: Feeding and growth differences, 5oz vs 8oz bottleSubject will feed infant with 8oz medela bottle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant or newborn aged 28 days or younger
Key exclusion criteria (1 listed)
- gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding and growth differences, 5oz vs 8oz bottleGroup A: 5oz bottle Group B: 8oz bottle | Behavioural | 5 oz bottle, 8 oz bottle |
Primary outcome
Change in Infant Weight-for-Age Z-score over time by group
Time frame: 2, 8 and 16 weeks of age
Infant weight (kg) (PEA POD scale) will be measured at each of three time points (2, 8, 16 weeks of age). Weight-for-Age Z-score (WAZ) will be calculated based on World Health Organization Global Database on Child Growth, means will be calculated and compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No. All data is de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leann L Birch, PhD principal investigator
The University of Georgia
Questions about this trial
What is this clinical trial studying?
A study testing Feeding and growth differences, 5oz vs 8oz bottle in people with Maternal Behavior and Body Weight, run by Leann Birch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infant Weight-for-Age Z-score over time by group (time frame: 2, 8 and 16 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.