Healthy Start to Feeding Intervention



Status:Not yet recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:10/13/2018
Start Date:November 1, 2018
End Date:July 31, 2019
Contact:Cathleen Stough, PhD
Email:odarcc@ucmail.uc.edu
Phone:513-556-5589

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Healthy Start to Feeding Pilot Trial

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.

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.

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
We found this trial at
1
site
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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