Adults 3 Months to 10 Months, any sex, with Weight, Body or Diet Habit. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Weight-for-Length PercentilePrimary· 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).
Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
Pre-treatment
Group
Value
95% CI
Healthy Start to Feeding Intervention
44.94
± 30.25
Control
46.70
± 26.97
Post-treatment
Group
Value
95% CI
Healthy Start to Feeding Intervention
58.69
± 31.78
Control
48.54
± 30.82
Appetite RegulationPrimary· 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).
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.
Pre-treatment: Food Responsiveness
Group
Value
95% CI
Healthy Start to Feeding Intervention
2.96
± .33
Control
3.01
± .24
Pre-treatment: Enjoyment of Food
Group
Value
95% CI
Healthy Start to Feeding Intervention
3.61
± .27
Control
3.72
± .35
Pre-treatment: Satiety Responsiveness
Group
Value
95% CI
Healthy Start to Feeding Intervention
1.92
± .49
Control
1.85
± .30
Pre-treatment: Slowness in Eating
Group
Value
95% CI
Healthy Start to Feeding Intervention
2.59
± .48
Control
2.73
± .48
Post-treatment: Food Responsiveness
Group
Value
95% CI
Healthy Start to Feeding Intervention
2.82
± .46
Control
2.97
± .29
Post-treatment: Enjoyment of Food
Group
Value
95% CI
Healthy Start to Feeding Intervention
3.70
± .26
Control
3.58
± .24
Post-treatment: Satiety Responsiveness
Group
Value
95% CI
Healthy Start to Feeding Intervention
1.54
± .45
Control
1.96
± .36
Post-treatment: Slowness in Eating
Group
Value
95% CI
Healthy Start to Feeding Intervention
2.41
± .41
Control
2.58
± .35
Fruit and Vegetable VarietyPrimary· 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).
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.
Post-treatment: Fruit Servings Per Day
Group
Value
95% CI
Healthy Start to Feeding Intervention
1.86
± 1.19
Control
2.19
± 1.11
Post-treatment: Veggie Servings Per Day
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.92
± 3.63
Control
5.10
± 3.75
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.Secondary· The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
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 individu
Appropriateness
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.60
± 1.06
Timing
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.47
± 1.13
Clarity
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.67
± 1.05
Implementation
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.67
± 1.05
Helpful
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.53
± .83
Satisfication
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.47
± 1.25
Would Recommend
Group
Value
95% CI
Healthy Start to Feeding Intervention
4.47
± 1.19
Treatment AttendanceSecondary· 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.
Treatment attendance was tracked for each family.
Attended Session 1
Group
Value
95% CI
Healthy Start to Feeding Intervention
16
Attended Session 2
Group
Value
95% CI
Healthy Start to Feeding Intervention
16
Attended Session 3
Group
Value
95% CI
Healthy Start to Feeding Intervention
16
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
Last refreshed: 10 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03597061.