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N/A N=34 Randomized Prevention

Healthy Start to Feeding Intervention

Weight, Body · Diet Habit

Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Weight-for-Length Percentile — 44.94; 46.70; 58.69; 48.54 Percentile

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Healthy Start to Feeding (Behavioral)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of Cincinnati
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Weight-for-Length Percentile
44.94; 46.70; 58.69; 48.54
PRIMARY
Appetite Regulation
2.96; 3.01; 3.61; 3.72; 1.92; 1.85
PRIMARY
Fruit and Vegetable Variety
1.86; 2.19; 4.92; 5.10
SECONDARY
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.
4.60; 4.47; 4.67; 4.67; 4.53; 4.47
SECONDARY
Treatment Attendance
16; 16; 16

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03597061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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