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Healthy Start to Feeding Intervention

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ClinicalTrials.gov Identifier: NCT03597061
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Cathy Stough, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Weight, Body Diet Habit Behavioral: Healthy Start to Feeding Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Infants will be assigned to either the treatment or control condition.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Start to Feeding Pilot Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

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.
Behavioral: Healthy Start to Feeding
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.



Primary Outcome Measures :
  1. Weight-for-Length Percentile [ Time Frame: Weight and length will be measured at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age). ]
    Infant anthropometrics of weight and length will be measured and used to calculate weight-for-length percentile standardized for age and gender.

  2. Appetite Regulation [ Time Frame: The BEBQ will be 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 will be 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.

  3. Fruit and Vegetable Variety [ Time Frame: The Block Food Frequency Questionnaire will be completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age). ]
    Fruit and vegetable variety will be assessed using the parent-report Block Food Frequency Questionnaire. Scores are calculated for: Calories, Protein, Total fat, Carbohydrate, Calcium, Phosphorus, Iron, Sodium, Potassium, Vitamins (A, B1, B2, B6, C, D, E), Niacin, Saturated fat, Monounsaturated fat, Polyunsaturated fat, Cholesterol, Fiber, Folate, Zinc, Magnesium, Cryptoxanthin, Lutein, Lycopene, Retinol, Pro-Vitamin A carots, Grams solid food, % of kcal from fat, % of kcal from carb, % kcal from sweets, Fiber from beans, Fiber from vegetables and fruits, Fiber from grains, Servings of vegetables, Frequency of eating fruits/fruit juices, Servings of bread/cereal/rice/pasta, Servings of meat/fish/poultry/beans/eggs, Servings of milk/yogurt/cheese, Frequency of eating fats/oils/sweet. The minimum value for all variables 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.


Secondary Outcome Measures :
  1. 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). ]
    Caregivers in the treatment condition will complete 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 provide 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.

  2. Treatment Attendance [ Time Frame: Attendance of sessions at study month 2, study month 4, and study month 7 will be recorded. The average number of the three sessions attended by each family will also be computed (range 0-3 with higher numbers indicating higher attendance). ]
    Treatment attendance will be tracked for each family.



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Ages Eligible for Study:   3 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597061


Contacts
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Contact: Cathleen Stough, PhD 513-556-5589 odarcc@ucmail.uc.edu

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Cathleen Stough, PhD    513-556-5589    odarcc@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Cathleen Stough, PhD University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Cathy Stough, University of Cincinnati:
Study Protocol  [PDF] August 14, 2018
Informed Consent Form  [PDF] August 14, 2018


Additional Information:
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Responsible Party: Cathy Stough, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03597061     History of Changes
Other Study ID Numbers: 2017-7248
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cathy Stough, University of Cincinnati:
obesity prevention
infant
complementary feeding
diet variety
weight-for-length
food responsiveness
satiety responsiveness

Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms