- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03597061
Healthy Start to Feeding Intervention
Healthy Start to Feeding Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to pilot test a prevention program to promote healthy introduction of solid foods and healthy weight gain among infants. Introduction of complementary foods (i.e., foods besides formula or breast milk) represents a major dietary milestone for infants. The current study will test the feasibility of a 3-session intervention encouraging healthy introduction of complementary foods and use of a responsive feeding approach. Feasibility of the intervention and the impact of the Healthy Start to Feeding (HSF) intervention on obesity risk factors and growth will be explored. This will be achieved through exploration of the following aims and hypotheses:
Aim 1: Determine feasibility of the intervention and family satisfaction with the treatment.
H1: Families assigned to the intervention condition will attend equal to or greater than 67% of treatment sessions.
H2: Families receiving the intervention will rate the program as helpful and consistent with the families' needs and priorities.
Aim 2: Test the impact of the HSF intervention on growth trajectories, appetite regulation, and diet at post-treatment.
H1: Infants receiving the intervention will experience lower incidence of high weight-for-length (> 85th percentile) compared to infants in the control condition.
H2: Infants in the treatment condition will show greater satiety responsiveness and lower food responsiveness as assessed through a well-validated parent-report measure (Baby Eating Behavior Questionnaire; Llewellyn, van Jaarsveld, Johnson, Carnell, & Wardle, 2010).
H3: Infants in the treatment condition will consume a greater variety of fruits and vegetables than infants in the control condition as assessed through a food frequency questionnaire completed by parents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Infant aged 2-3 months at study recruitment
- Infant not previously introduced to complementary foods (i.e., any food besides formula or breastmilk)
- Infant born at > 38 weeks gestation
- Infant weight-for-length > 10th percentile
- Parent is fluent English speaker
Exclusion Criteria:
- Known infant developmental delay
- Impaired infant fine or gross motor skills
- Condition currently impacting the infant's feeding and eating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Start to Feeding Intervention
Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods.
Intervention sessions will occur when the infant is 4, 6, and 9 months of age.
|
The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy.
Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist.
Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content.
Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding.
|
No Intervention: Control
Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes.
They will receive no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight-for-Length Percentile
Time Frame: Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).
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Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
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Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).
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Appetite Regulation
Time Frame: The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
|
Infant satiety and food responsiveness was measured using the parent-report Baby Eating Behavior Questionnaire (BEBQ).
The BEBQ provides subscale scores for "Food Responsiveness", "Enjoyment of Food", "Satiety Responsiveness", and "Slowness in Eating" with each subscale score ranging from 1 to 5, with 5 representing higher values on that construct.
Each subscale score is computed as the average of all individual items on that subscales.
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The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
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Fruit and Vegetable Variety
Time Frame: The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
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Fruit and vegetable variety was assessed using the parent-report Block Food Frequency Questionnaire.
Scores were calculated for servings of vegetables per day and servings of fruits per day.
The minimum value is 0. There is no upper-bound for the maximum value, as this is dependent on the individual participant's food consumption.
Higher numbers indicate greater consumption.
Only post-treatment results are presented since infants had not been introduced to solid foods at the time of baseline.
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The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Satisfaction - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.
Time Frame: The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
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Caregivers in the treatment condition completed a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker.
Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating higher agreement.
Information from each individual item will be used, and no total or subscale scores will be computed.
Parents also provided qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.
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The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
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Treatment Attendance
Time Frame: Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.
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Treatment attendance was tracked for each family.
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Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cathleen Stough, PhD, University of Cincinnati
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-7248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data collected will be shared through 1) dissemination of aggregate data through scientific publication, summary on the research laboratory's website, and presentation at regional, national, and international conferences and 2) availability of data to requesting researchers and investigators. Researchers interested in receiving the dataset should request the dataset from the principal investigator.
In addition to these two avenues for data sharing, if provided the opportunity at the time of publication, the dataset will be uploaded to any data repository offered through the scientific journal in which findings are published.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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