Clinical trial NCT03597061: Healthy Start to Feeding Intervention
Official title: Healthy Start to Feeding Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight, Body
Diet Habit
Keywords: obesity prevention
infant
complementary feeding
diet variety
weight-for-length
food responsiveness
satiety responsiveness
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2018-07-24
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be assigned to either the treatment or control condition.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight-for-Length Percentile
timeFrame: 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).
measure: Appetite Regulation
timeFrame: 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).
measure: Fruit and Vegetable Variety
timeFrame: 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 outcomes:
measure: 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.
timeFrame: The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
measure: Treatment Attendance
timeFrame: 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.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Cathleen Stough, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.