Childhood ObesityNCT00994487
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
A study testing High Energy Density Preload and Low Energy Density Preload in people with Childhood Obesity and Breastfeeding, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this study is to compare female, preschool-aged children breastfed during infancy to female, preschool-aged children bottle-fed during infancy in their ability to adjust calorie intake in response to internal signals of hunger and fullness. Read more about this study
- Who is it for?
- Ages 3 to 5 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Breastfeeding
- What is being tested?
- High Energy Density Preload and Low Energy Density Preload
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2010
- 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 3 to 5 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Children will be eligible for study participation if they meet the following criteria:
- female
- BMI between the 5th and the 85th percentile
- were of normal birth weight (>2500 g)
- full-term
- have no chronic disease conditions effecting growth and intake
Show all 12Show fewer
- have not been in foster care for longer than one month (if at all)
- are between 3 and 5 years of age
- are willing to consume and are not allergic to the preloads and meals used in the study
- are not lactose-intolerant
- have a parent who is able to recall mode of feeding in infancy and was either exclusively breast-fed from birth to 3 months of age (defined as being fed from a bottle on average < 1 time per week from birth to 3 months of age, with all other feedings from the breast) or was exclusively bottle-fed from birth to 3 months of age (defined as being completely bottle-fed, with feedings comprised of formula and/or breastmilk)
- have a parent willing to transport child to the University of Tennessee lab at two different times during their participation in the project
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
The purpose of this study is to compare female, preschool-aged children breastfed during infancy to female, preschool-aged children bottle-fed during infancy in their ability to adjust calorie intake in response to internal signals of hunger and fullness. Children and a parent will come to two sessions, with the children given drinks that are either high or low in energy, and then consume a lunch following the drink. The parent will be present during the lunch. Greater ability to self-regulate intake is demonstrated when less energy is consumed at lunch following the high energy drink as compared to the lunch following the low energy drink. Lunches will be videotaped so that parental feeding styles (i.e., how the parent interacted with the child during lunch) can be examined. The primary hypotheses are: 1.) the exclusively breastfed children will have higher self-regulation ability than the exclusively bottle-fed children, and 2.) the mothers of the exclusively breastfed children will demonstrate a parental feeding style characterized by less control and restriction than the mothers (or parent primarily responsible for child feeding) of the exclusively bottle-fed children.
Read the detailed description
Research reports that children who were breastfed as infants have a decreased risk of becoming obese. However, it is not clear how breastfeeding may prevent the development of obesity. Breastfeeding may support the maintenance of sensitivity to internal hunger/fullness cues, which helps with self-regulating energy intake. Additionally, breastfeeding may facilitate the development of a parental feeding style low in control or restriction. This type of feeding style is also associated with greater ability to self-regulate energy intake. Bottle-feeding shifts feeding control to parents, and may lead to a parental feeding style high in control or restriction, impairing children's self-regulation abilities.
The aims of this study are to determine in females aged 3-5 years if: 1.) breastfed children have greater energy self- regulation capabilities; 2.) parents of breastfed children demonstrate a parental feeding style characterized by less control or restriction; and 3.) children with the greatest energy self-regulation capabilities were breastfed and have parents with feeding styles lowest in control or restriction. It is hypothesized that female, preschool-aged children breastfed and/or parented with a feeding style low in control or restriction self-regulate intake better than females not breastfed and/or parented with a feeding style high in control or restriction.
A within-subjects, counterbalanced design, using a standard preloading paradigm, will measure children's ability to self-regulate intake to preloads of differing energy densities. Children and a parent will participate in two trials, with children consuming preloads high and low in energy followed by a lunch in which energy intake is measured. Lunch will be videotaped so parental feeding style during the child's lunch can be coded for restriction and control. Results will provide information about potential mechanisms by which breastfeeding reduces the risk of obesity and obesity related diseases in children.
- Conditions
- Childhood Obesity, Breastfeeding
- Being tested
- High Energy Density Preload, Low Energy Density Preload
- Keywords
- Childhood Obesity, Breastfeeding, Bottle Feeding, Dietary Intake, Preload, Compensation, Parental Feeding Style
- Medical subject headings
- Pediatric Obesity, Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Energy Density PreloadOther
Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles
Low Energy Density PreloadOther
Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles.
| Study group | Role | What they receive |
|---|---|---|
| Breastfed child | Experimental | Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age Receives: Other: High Energy Density Preload; Other: Low Energy Density Preload |
| Bottle Fed Child | Active comparator | Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age Receives: Other: High Energy Density Preload; Other: Low Energy Density Preload |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compensation for high energy density and low energy density preloads
Measured: 2 days
Secondary outcomes (1)
Parental feeding style
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, Principal investigator, University of TennesseeKatie Kavanagh, PhD, Study chair, Univerisity of TennesseeHiliary Fouts, PhD, Study chair, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994487
- Sponsor's protocol ID
- 7828B
- Status last verified
- Apr 2018
- First submitted
- 12 Oct 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
- ClinicalTrials.gov ID
- NCT00994487
- Acronym / sponsor ID
- 7828B
- Conditions
- Childhood Obesity, Breastfeeding
- Keywords
- Childhood Obesity, Breastfeeding, Bottle Feeding, Dietary Intake, Preload, Compensation, Parental Feeding Style
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Oct 2009 (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.
The purpose of this study is to compare female, preschool-aged children breastfed during infancy to female, preschool-aged children bottle-fed during infancy in their ability to adjust calorie intake in response to internal signals of hunger and fullness. Children and a parent will come to two sessions, with the children given drinks that are either high or low in energy, and then consume a lunch following the drink. The parent will be present during the lunch. Greater ability to self-regulate intake is demonstrated when less energy is consumed at lunch following the high energy drink as compared to the lunch following the low energy drink. Lunches will be videotaped so that parental feeding styles (i.e., how the parent interacted with the child during lunch) can be examined. The primary hypotheses are: 1.) the exclusively breastfed children will have higher self-regulation ability than the exclusively bottle-fed children, and 2.) the mothers of the exclusively breastfed children will demonstrate a parental feeding style characterized by less control and restriction than the mothers (or parent primarily responsible for child feeding) of the exclusively bottle-fed children.
Detailed description
Research reports that children who were breastfed as infants have a decreased risk of becoming obese. However, it is not clear how breastfeeding may prevent the development of obesity. Breastfeeding may support the maintenance of sensitivity to internal hunger/fullness cues, which helps with self-regulating energy intake. Additionally, breastfeeding may facilitate the development of a parental feeding style low in control or restriction. This type of feeding style is also associated with greater ability to self-regulate energy intake. Bottle-feeding shifts feeding control to parents, and may lead to a parental feeding style high in control or restriction, impairing children's self-regulation abilities.
The aims of this study are to determine in females aged 3-5 years if: 1.) breastfed children have greater energy self- regulation capabilities; 2.) parents of breastfed children demonstrate a parental feeding style characterized by less control or restriction; and 3.) children with the greatest energy self-regulation capabilities were breastfed and have parents with feeding styles lowest in control or restriction. It is hypothesized that female, preschool-aged children breastfed and/or parented with a feeding style low in control or restriction self-regulate intake better than females not breastfed and/or parented with a feeding style high in control or restriction.
A within-subjects, counterbalanced design, using a standard preloading paradigm, will measure children's ability to self-regulate intake to preloads of differing energy densities. Children and a parent will participate in two trials, with children consuming preloads high and low in energy followed by a lunch in which energy intake is measured. Lunch will be videotaped so parental feeding style during the child's lunch can be coded for restriction and control. Results will provide information about potential mechanisms by which breastfeeding reduces the risk of obesity and obesity related diseases in children.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfed child | Experimental | Other: High Energy Density Preload, Other: Low Energy Density PreloadFemale, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age |
| Bottle Fed Child | Active comparator | Other: High Energy Density Preload, Other: Low Energy Density PreloadFemale, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- female
- BMI between the 5th and the 85th percentile
- were of normal birth weight (>2500 g)
- full-term
- have no chronic disease conditions effecting growth and intake
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| High Energy Density PreloadEach child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles | Other | Bottle Fed Child, Breastfed child |
| Low Energy Density PreloadEach child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles. | Other | Bottle Fed Child, Breastfed child |
Primary outcome
Compensation for high energy density and low energy density preloads
Time frame: 2 days
1 secondary outcome
Parental feeding style
Time frame: 2 days
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 5 Apr 2018.
- Website for the Healthy Eating and Activity Laboratory (HEAL) where the study is conductedLink provided by the sponsor.
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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.
Hollie A Raynor, PhD principal investigator
University of Tennessee
Katie Kavanagh, PhD study chair
Univerisity of Tennessee
Hiliary Fouts, PhD study chair
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Energy Density Preload and Low Energy Density Preload in people with Childhood Obesity and Breastfeeding, run by The University of Tennessee, Knoxville at 1 site in United States.
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 12 inclusion and 0 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Compensation for high energy density and low energy density preloads (time frame: 2 days). 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 5 Apr 2018.