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Healthy Start to Feeding Intervention

Primary Purpose

Weight, Body, Diet Habit

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Start to Feeding
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight, Body focused on measuring obesity prevention, infant, complementary feeding, diet variety, weight-for-length, food responsiveness, satiety responsiveness

Eligibility Criteria

3 Months - 10 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Healthy Start to Feeding Intervention

Control

Arm Description

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.

Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.

Outcomes

Primary Outcome Measures

Weight-for-Length Percentile
Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
Appetite Regulation
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.
Fruit and Vegetable Variety
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.

Secondary Outcome Measures

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.
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.
Treatment Attendance
Treatment attendance was tracked for each family.

Full Information

First Posted
June 27, 2018
Last Updated
May 8, 2023
Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03597061
Brief Title
Healthy Start to Feeding Intervention
Official Title
Healthy Start to Feeding Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 19, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study will test the impact of a 3-session obesity prevention program targeting healthy introduction of solid foods in infancy on growth trajectories, appetite regulation, and diet. The investigators will also test the feasibility and family satisfaction with the treatment. Healthy infants with normal and elevated weight-for-length will be enrolled in the study at 3 months of age and complete an initial study visit to assess baseline anthropometrics,demographics, parental feeding practices and beliefs, and infant appetite. Infants will than be randomly assigned to either the treatment condition (n = 20) or control condition (n = 20). Infants in the control condition will receive no intervention or further contact with the study team besides for completion of a final study assessment visit when the child is 9 months old. Infants in the treatment condition will receive a 3 session intervention targeting healthy introduction of solid foods, with study visits occurring when the child is 4 months, 6 months, and 9 months old. All families will complete a final study visit to complete post-treatment period measurements, which will include infant anthropometrics and parent-report of infant appetite, infant diet, and parental feeding practices and beliefs. Outcomes include: weight-for-length percentile, infant satiety responsiveness, infant food responsiveness, and infant fruit and vegetable consumption. Family satisfaction and treatment attendance will also be assessed.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight, Body, Diet Habit
Keywords
obesity prevention, infant, complementary feeding, diet variety, weight-for-length, food responsiveness, satiety responsiveness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Infants will be assigned to either the treatment or control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Start to Feeding Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Start to Feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight-for-Length Percentile
Description
Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
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).
Title
Appetite Regulation
Description
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.
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).
Title
Fruit and Vegetable Variety
Description
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.
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).
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
Title
Treatment Attendance
Description
Treatment attendance was tracked for each family.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathleen Stough, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Data collected at baseline will be made available at the time of acceptance of the first publication presenting this data, which will be submitted for publication no later than 1 year following the completion of baseline data collection. All other data collected throughout the project will be made available at the time of acceptance of the primary treatment outcomes paper, which will be submitted for publication no later than 1 year following the completion of the last post-treatment visit.
IPD Sharing Access Criteria
Requesting researchers and investigators will be asked to use the data only for IRB-approved or exempted research purposes and to present only aggregate descriptions of data that do not identify any one participant.
Citations:
PubMed Identifier
32710657
Citation
Ojha S, Elfzzani Z, Kwok TC, Dorling J. Education of family members to support weaning to solids and nutrition in later infancy in term-born infants. Cochrane Database Syst Rev. 2020 Jul 25;7(7):CD012241. doi: 10.1002/14651858.CD012241.pub2.
Results Reference
derived

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Healthy Start to Feeding Intervention

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