OverweightHBNCT01816516
Healthy Babies Through Infant Centered Feeding
A study testing Healthy Babies and Expanded Food and Nutrition Education Program in people with Overweight and Obesity, run by Michigan State University at 2 sites in United States.
Trial summary
Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight, Obesity, Infant Overnutrition
- What is being tested?
- Healthy Babies and Expanded Food and Nutrition Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Feb 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers aged 18 or older with one, two or three children
- Infants of low-risk births aged birth to 4 months who have not been introduced to solid foods
- Low income (those who qualify for EFNEP, income at or below 185% - 200% of the federal poverty level)
- Infants born between 37 and 42 weeks gestational age with birth weight between 5 pounds 8 ounces and 8 pounds 13 ounces
Who cannot join
- Male caregivers
- Mothers and/or infants diagnosed with feeding or eating disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michigan State University
East Lansing, Michigan, 48824
Colorado State University
Fort Collins, Colorado, 80523
About this study
Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. The goal of the project is to provide an educational intervention that fosters appropriate maternal responsiveness, feeding styles, and feeding practices via infant-centered feeding.
Read the detailed description
The long-term goal of this integrated project is to contribute to curbing the rising rates of childhood obesity through an effective, multi-component, relationship skill-building and educational intervention that fosters infant-centered feeding to promote appropriate maternal responsiveness, feeding styles, and feeding practices as infants transition to solid foods.
Research Objectives: To evaluate effectiveness of Healthy Babies (HB) compared to the Expanded Food and Nutrition Education Program (EFNEP) at two points in time (when the infant is 6 and 12 months of age) for mothers of infants on maternal responsiveness, feeding style, and feeding practices as infants' transition to solid foods, and to compare infant feeding self-regulation and growth pattern of infants at 6 and 12 months of age between the two groups, HB and EFNEP.
Hypothesis: Compared to mothers of infants who receive traditional EFNEP lessons, mothers who receive HB lessons will achieve an improvement (when the infant is 6 months old that is sustained over time when the infant is 12 months of age) on:
- Maternal responsiveness (measured by appropriately interpreting and responding to infant cues when transitioning their infants to solid foods on the Parent-Child Interaction-Feeding Scale [PCI-F]).
- Maternal feeding styles (measured by feeding beliefs and behaviors on the Infant Feeding Styles Questionnaire).
- Feeding practices (measured by use of appropriate feeding practices when transitioning their infants to solid foods on the PCI-F).
Research Question: How do infants in the HB (intervention) group compare to the infants in the traditional EFNEP group when the infant is 6 and 12 months old on:
- Infant feeding self-regulation (measured by clarity of cues and feeding responsiveness on the PCI-F).
- Infant growth patterns (measured by growth charts).
Extension Objective: To evaluate feasibility, fidelity, and educational effectiveness of the HB intervention. (Process Evaluation)
Research Question: What is the feasibility of integration within Extension by paraprofessionals who deliver HB and for mothers of infants' who receive the HB lessons, related to:
- Paraprofessionals' training, ability to deliver the intervention (fidelity), and satisfaction with the intervention; and
- Mothers' acceptance (recruitment), completion (retention), and satisfaction with the intervention.
Research Question: What is the educational effect of the intervention on maternal knowledge, attitudes, and self-efficacy related to infant feeding?
Research Design. The study will use a randomized clinical trial design in which participants from Michigan (MI) and Colorado (CO) will be randomly assigned to the HB intervention or control (EFNEP) group. The HB intervention, delivered by paraprofessionals (educators), is designed to foster appropriate maternal responsiveness, feeding style, and feeding practices. Participants will be blinded to their group assignment. Data will be collected at three time points by a separate data collection team (not educators): baseline (before the first lesson), follow-up (when infant is six months old), and post follow-up (when infant is 12 months old). These time points have been selected based on the infant's age, such that when an infant is six months old, this is the usual time frame when introducing solid food is recommended to be initiated for all infants, and at 12 months, infants should have an established eating pattern of solid foods. Thus, these points in time were selected rather than immediately following the lessons for consistency in infant age. The age of the infant at time of enrollment will be standardized for timing of the intervention, such that the intervention will begin for all infants between 1 and 4 months of age. Three time points are included to make statistical comparisons and assess the sustainability of changes. Process data will be collected throughout the study.
Participant Recruitment. A total of 546 mother-infant were recruited through community agencies providing services to pregnant women and mothers of infants in Michigan and Colorado (i.e., EFNEP, Breast Feeding Initiative, and Women, Infants and Children's Special Supplemental Nutrition Program for Women, Infants, and Children). Given each state's demographics, Michigan is has a higher proportion of Black minority dyads and Colorado a higher proportion of Hispanic/Latina dyads. Though race/ethnicity/culture is not a specific focus of the study, the sample size will allow us to examine race/ethnic/cultural similarities and differences.
The investigators have recruited of 546 eligible families in MI and CO which will allow for 25% attrition (at each data collection), leaving 278 families at post follow-up (when infant is 12 months old) available for data analysis.
- Conditions
- Overweight, Obesity, Infant Overnutrition, Feeding Behavior, Feeding Patterns
- Being tested
- Healthy Babies, Expanded Food and Nutrition Education Program
- Keywords
- childhood obesity, low-income, maternal responsiveness, infant feeding, infant feeding practices, infant feeding style, primary prevention
- Medical subject headings
- Overweight, Obesity, Infant Nutrition Disorders, Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy BabiesBehavioural
Each lesson is designed to promote the development of healthy infant eating, and incorporates research-based information, opportunities for mothers to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques. During lessons, mothers engage in activities in support of lesson goals. Intervention strategies focusing on feeding practices will include modification of the feeding environment (e.g., television off during feeding).
The telephone contacts, 10 minutes in length, made at 6, 8, and 10 months, reinforce key concepts in the lessons after conclusion of the intervention to maintain effects.
Expanded Food and Nutrition Education ProgramBehavioural
Core EFNEP concepts are United States Department of Agriculture (USDA) My Pyramid, fruits, vegetables, meats, whole grains, food safety, and food resource management. Educators for the EFNEP group will use the EFNEP lessons which address basic knowledge customized for families with infants. Mothers in the EFNEP group will receive a series of six lessons from the nutrition education program offered in each state; they provide a series of lessons focused on nutrition education for families and do not include extensive content on feeding infants.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Babies | Experimental | Participants receive the Healthy Babies curriculum via 6 in home lessons and 3 follow up telephone calls delivered by Extension paraprofessionals. Receives: Behavioral: Healthy Babies |
| EFNEP | Active comparator | Participants receive the Expanded Food and Nutrition Education Program (EFNEP) curriculum via 6 in home lessons delivered by Extension paraprofessionals. Receives: Behavioral: Expanded Food and Nutrition Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)
Change in maternal responsiveness is measured through an Observational measure (mother-infant feeding interaction): Maternal Responsiveness via Parent-Child Interaction-Feeding Scale (PCI-F) (Formerly Nursing Child Assessment of Feeding Scale)
Measured: Change from Baseline in Maternal Responsiveness at 6 months
Change in Baseline in Maternal Responsiveness at different time points (6 months and 12 months)
Change in Baseline in maternal responsiveness at 12 months is measured via an observational tool: Parent-Child Interaction -Feeding Scale.
Measured: Change in Baseline in Maternal Responsiveness at 12 months
Secondary outcomes (2)
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Change in Feeding Practices is assessed via The Infant Feeding Scale (IFS)
Measured: Change in Baseline in Feeding Practices at 6 months
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Change in Baseline in Feeding Practices at 12 months is assessed using the Infant Feeding Scale
Measured: Change in Baseline in feeding practices at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Colorado State University
- Responsible party
- Principal investigator, Mildred Horodynski, Michigan State University
- Investigators
- Mildred Horodynski, PhD, RN, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816516
- Sponsor's protocol ID
- 2009-55215-05220
- Other IDs
- 2009
- Acronym
- HB
- Status last verified
- May 2014
- First submitted
- 18 Mar 2013
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Horodynski MA, Olson B, Baker S, Brophy-Herb H, Auld G, Van Egeren L, Lindau J, Singleterry L. Healthy babies through infant-centered feeding protocol: an intervention targeting early childhood obesity in vulnerable populations. BMC Public Health. 2011 Nov 15;11:868. doi: 10.1186/1471-2458-11-868.
PubMed 22085421Horodynski MA, Baker S, Van Egeren L, Olson B, Brophy-Herb H, Auld G. The healthy babies curriculum. J Nutr Educ Behav. 2014 Mar-Apr;46(2):151-2. doi: 10.1016/j.jneb.2013.10.002. Epub 2013 Nov 23. No abstract available.
PubMed 24280320
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Babies Through Infant Centered Feeding
- ClinicalTrials.gov ID
- NCT01816516
- Acronym / sponsor ID
- HB / 2009-55215-05220
- Conditions
- Overweight, Obesity, Infant Overnutrition, Feeding Behavior, Feeding Patterns
- Keywords
- childhood obesity, low-income, maternal responsiveness, infant feeding, infant feeding practices, infant feeding style, primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Colorado State University
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Mar 2013 (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.
Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. The goal of the project is to provide an educational intervention that fosters appropriate maternal responsiveness, feeding styles, and feeding practices via infant-centered feeding.
Detailed description
The long-term goal of this integrated project is to contribute to curbing the rising rates of childhood obesity through an effective, multi-component, relationship skill-building and educational intervention that fosters infant-centered feeding to promote appropriate maternal responsiveness, feeding styles, and feeding practices as infants transition to solid foods.
Research Objectives: To evaluate effectiveness of Healthy Babies (HB) compared to the Expanded Food and Nutrition Education Program (EFNEP) at two points in time (when the infant is 6 and 12 months of age) for mothers of infants on maternal responsiveness, feeding style, and feeding practices as infants' transition to solid foods, and to compare infant feeding self-regulation and growth pattern of infants at 6 and 12 months of age between the two groups, HB and EFNEP.
Hypothesis: Compared to mothers of infants who receive traditional EFNEP lessons, mothers who receive HB lessons will achieve an improvement (when the infant is 6 months old that is sustained over time when the infant is 12 months of age) on:
- Maternal responsiveness (measured by appropriately interpreting and responding to infant cues when transitioning their infants to solid foods on the Parent-Child Interaction-Feeding Scale [PCI-F]).
- Maternal feeding styles (measured by feeding beliefs and behaviors on the Infant Feeding Styles Questionnaire).
- Feeding practices (measured by use of appropriate feeding practices when transitioning their infants to solid foods on the PCI-F).
Research Question: How do infants in the HB (intervention) group compare to the infants in the traditional EFNEP group when the infant is 6 and 12 months old on:
- Infant feeding self-regulation (measured by clarity of cues and feeding responsiveness on the PCI-F).
- Infant growth patterns (measured by growth charts).
Extension Objective: To evaluate feasibility, fidelity, and educational effectiveness of the HB intervention. (Process Evaluation)
Research Question: What is the feasibility of integration within Extension by paraprofessionals who deliver HB and for mothers of infants' who receive the HB lessons, related to:
- Paraprofessionals' training, ability to deliver the intervention (fidelity), and satisfaction with the intervention; and
- Mothers' acceptance (recruitment), completion (retention), and satisfaction with the intervention.
Research Question: What is the educational effect of the intervention on maternal knowledge, attitudes, and self-efficacy related to infant feeding?
Research Design. The study will use a randomized clinical trial design in which participants from Michigan (MI) and Colorado (CO) will be randomly assigned to the HB intervention or control (EFNEP) group. The HB intervention, delivered by paraprofessionals (educators), is designed to foster appropriate maternal responsiveness, feeding style, and feeding practices. Participants will be blinded to their group assignment. Data will be collected at three time points by a separate data collection team (not educators): baseline (before the first lesson), follow-up (when infant is six months old), and post follow-up (when infant is 12 months old). These time points have been selected based on the infant's age, such that when an infant is six months old, this is the usual time frame when introducing solid food is recommended to be initiated for all infants, and at 12 months, infants should have an established eating pattern of solid foods. Thus, these points in time were selected rather than immediately following the lessons for consistency in infant age. The age of the infant at time of enrollment will be standardized for timing of the intervention, such that the intervention will begin for all infants between 1 and 4 months of age. Three time points are included to make statistical comparisons and assess the sustainability of changes. Process data will be collected throughout the study.
Participant Recruitment. A total of 546 mother-infant were recruited through community agencies providing services to pregnant women and mothers of infants in Michigan and Colorado (i.e., EFNEP, Breast Feeding Initiative, and Women, Infants and Children's Special Supplemental Nutrition Program for Women, Infants, and Children). Given each state's demographics, Michigan is has a higher proportion of Black minority dyads and Colorado a higher proportion of Hispanic/Latina dyads. Though race/ethnicity/culture is not a specific focus of the study, the sample size will allow us to examine race/ethnic/cultural similarities and differences.
The investigators have recruited of 546 eligible families in MI and CO which will allow for 25% attrition (at each data collection), leaving 278 families at post follow-up (when infant is 12 months old) available for data analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Babies | Experimental | Behavioral: Healthy BabiesParticipants receive the Healthy Babies curriculum via 6 in home lessons and 3 follow up telephone calls delivered by Extension paraprofessionals. |
| EFNEP | Active comparator | Behavioral: Expanded Food and Nutrition Education ProgramParticipants receive the Expanded Food and Nutrition Education Program (EFNEP) curriculum via 6 in home lessons delivered by Extension paraprofessionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers aged 18 or older with one, two or three children
- Infants of low-risk births aged birth to 4 months who have not been introduced to solid foods
- Low income (those who qualify for EFNEP, income at or below 185% - 200% of the federal poverty level)
- Infants born between 37 and 42 weeks gestational age with birth weight between 5 pounds 8 ounces and 8 pounds 13 ounces
Key exclusion criteria (2 listed)
- Male caregivers
- Mothers and/or infants diagnosed with feeding or eating disorders
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 |
|---|---|---|
| Healthy BabiesEach lesson is designed to promote the development of healthy infant eating, and incorporates research-based information, opportunities for mothers to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques. During lessons, mothers engage in activities in support of lesson goals. Intervention strategies focusing on feeding practices will include modification of the feeding environment (e.g., television off during feeding). The telephone contacts, 10 minutes in length, made at 6, 8, and 10 months, reinforce key concepts in the lessons after conclusion of the intervention to maintain effects. | Behavioural | Healthy Babies |
| Expanded Food and Nutrition Education ProgramCore EFNEP concepts are United States Department of Agriculture (USDA) My Pyramid, fruits, vegetables, meats, whole grains, food safety, and food resource management. Educators for the EFNEP group will use the EFNEP lessons which address basic knowledge customized for families with infants. Mothers in the EFNEP group will receive a series of six lessons from the nutrition education program offered in each state; they provide a series of lessons focused on nutrition education for families and do not include extensive content on feeding infants. | Behavioural | EFNEP |
Primary outcome
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)
Time frame: Change from Baseline in Maternal Responsiveness at 6 months
Change in maternal responsiveness is measured through an Observational measure (mother-infant feeding interaction): Maternal Responsiveness via Parent-Child Interaction-Feeding Scale (PCI-F) (Formerly Nursing Child Assessment of Feeding Scale)
Change in Baseline in Maternal Responsiveness at different time points (6 months and 12 months)
Time frame: Change in Baseline in Maternal Responsiveness at 12 months
Change in Baseline in maternal responsiveness at 12 months is measured via an observational tool: Parent-Child Interaction -Feeding Scale.
2 secondary outcomes
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Time frame: Change in Baseline in Feeding Practices at 6 months
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Time frame: Change in Baseline in feeding practices at 12 months
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 2 Jun 2014.
- Background: PubMed 22085421Horodynski MA, Olson B, Baker S, Brophy-Herb H, Auld G, Van Egeren L, Lindau J, Singleterry L. Healthy babies through infant-centered feeding protocol: an intervention targeting early childhood obesity in vulnerable populations. BMC Public Health. 2011 Nov 15;11:868. doi: 10.1186/1471-2458-11-868.
- Results publication: PubMed 24280320Horodynski MA, Baker S, Van Egeren L, Olson B, Brophy-Herb H, Auld G. The healthy babies curriculum. J Nutr Educ Behav. 2014 Mar-Apr;46(2):151-2. doi: 10.1016/j.jneb.2013.10.002. Epub 2013 Nov 23. No abstract available.
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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.
Mildred Horodynski, PhD, RN principal investigator
Michigan State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Babies and Expanded Food and Nutrition Education Program in people with Overweight and Obesity, run by Michigan State University at 2 sites 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 4 inclusion and 2 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 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months) (time frame: Change from Baseline in Maternal Responsiveness at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816516, which also lists 2 linked publications.
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 2 Jun 2014.