Trial Outcomes & Findings for Healthy Start to Feeding Intervention (NCT NCT03597061)
NCT ID: NCT03597061
Last Updated: 2023-05-10
Results Overview
Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome 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).
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
Control
Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control
Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
|
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Healthy Start to Feeding Intervention
Baseline characteristics by cohort
| Measure |
Healthy Start to Feeding Intervention
n=17 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
n=17 Participants
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
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).Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.
Outcome measures
| Measure |
Healthy Start to Feeding Intervention
n=16 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
n=16 Participants
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
|---|---|---|
|
Weight-for-Length Percentile
Pre-treatment
|
44.94 Percentile
Standard Deviation 30.25
|
46.70 Percentile
Standard Deviation 26.97
|
|
Weight-for-Length Percentile
Post-treatment
|
58.69 Percentile
Standard Deviation 31.78
|
48.54 Percentile
Standard Deviation 30.82
|
PRIMARY outcome
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).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.
Outcome measures
| Measure |
Healthy Start to Feeding Intervention
n=16 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
n=16 Participants
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
|---|---|---|
|
Appetite Regulation
Pre-treatment: Food Responsiveness
|
2.96 Score on a scale
Standard Deviation .33
|
3.01 Score on a scale
Standard Deviation .24
|
|
Appetite Regulation
Pre-treatment: Enjoyment of Food
|
3.61 Score on a scale
Standard Deviation .27
|
3.72 Score on a scale
Standard Deviation .35
|
|
Appetite Regulation
Pre-treatment: Satiety Responsiveness
|
1.92 Score on a scale
Standard Deviation .49
|
1.85 Score on a scale
Standard Deviation .30
|
|
Appetite Regulation
Pre-treatment: Slowness in Eating
|
2.59 Score on a scale
Standard Deviation .48
|
2.73 Score on a scale
Standard Deviation .48
|
|
Appetite Regulation
Post-treatment: Food Responsiveness
|
2.82 Score on a scale
Standard Deviation .46
|
2.97 Score on a scale
Standard Deviation .29
|
|
Appetite Regulation
Post-treatment: Enjoyment of Food
|
3.70 Score on a scale
Standard Deviation .26
|
3.58 Score on a scale
Standard Deviation .24
|
|
Appetite Regulation
Post-treatment: Satiety Responsiveness
|
1.54 Score on a scale
Standard Deviation .45
|
1.96 Score on a scale
Standard Deviation .36
|
|
Appetite Regulation
Post-treatment: Slowness in Eating
|
2.41 Score on a scale
Standard Deviation .41
|
2.58 Score on a scale
Standard Deviation .35
|
PRIMARY outcome
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).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.
Outcome measures
| Measure |
Healthy Start to Feeding Intervention
n=16 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
n=16 Participants
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
|---|---|---|
|
Fruit and Vegetable Variety
Post-treatment: Fruit Servings Per Day
|
1.86 Servings per day
Standard Deviation 1.19
|
2.19 Servings per day
Standard Deviation 1.11
|
|
Fruit and Vegetable Variety
Post-treatment: Veggie Servings Per Day
|
4.92 Servings per day
Standard Deviation 3.63
|
5.10 Servings per day
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: 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 individual item will be used, and no total or subscale scores will be computed. Parents also provided 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.
Outcome measures
| Measure |
Healthy Start to Feeding Intervention
n=15 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
|---|---|---|
|
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.
Appropriateness
|
4.60 Item scores
Standard Deviation 1.06
|
—
|
|
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.
Timing
|
4.47 Item scores
Standard Deviation 1.13
|
—
|
|
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.
Clarity
|
4.67 Item scores
Standard Deviation 1.05
|
—
|
|
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.
Implementation
|
4.67 Item scores
Standard Deviation 1.05
|
—
|
|
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.
Helpful
|
4.53 Item scores
Standard Deviation .83
|
—
|
|
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.
Satisfication
|
4.47 Item scores
Standard Deviation 1.25
|
—
|
|
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.
Would Recommend
|
4.47 Item scores
Standard Deviation 1.19
|
—
|
SECONDARY outcome
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.Treatment attendance was tracked for each family.
Outcome measures
| Measure |
Healthy Start to Feeding Intervention
n=16 Participants
Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.
Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was 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 were conducted individually with participants and primary caregivers and included 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 included 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.
|
Control
Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
|
|---|---|---|
|
Treatment Attendance
Attended Session 1
|
16 Participants
|
—
|
|
Treatment Attendance
Attended Session 2
|
16 Participants
|
—
|
|
Treatment Attendance
Attended Session 3
|
16 Participants
|
—
|
Adverse Events
Healthy Start to Feeding Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place