Trial Outcomes & Findings for Promoting The Self-Regulation Of Energy Intake (NCT NCT01513343)
NCT ID: NCT01513343
Last Updated: 2023-05-15
Results Overview
Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to \<85th percentile), overweight (≥85th to \<95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.
COMPLETED
NA
255 participants
12-month follow-up
2023-05-15
Participant Flow
Parent/child dyads were recruited in 2014-2016 from Head Start centers in Houston, TX, and child care centers serving families with low incomes in Pasco, WA. The Pasco centers were similar to Head Start in that they provided free services and support for families with low incomes. The goal of these centers was to ensure that all children enter kindergarten ready to succeed.
No significant events occurred in this study after participant enrollment.
Participant milestones
| Measure |
Parent and Child Classes (Prevention Group)
Parent and child groups focused on self-regulation of eating
|
Treatment as Usual (Control Group)
Treatment as usual, parents and children did not receive any treatment as the control group.
|
|---|---|---|
|
Group Allocation
STARTED
|
136
|
119
|
|
Group Allocation
COMPLETED
|
128
|
119
|
|
Group Allocation
NOT COMPLETED
|
8
|
0
|
|
Post Data Collection
STARTED
|
136
|
119
|
|
Post Data Collection
COMPLETED
|
119
|
95
|
|
Post Data Collection
NOT COMPLETED
|
17
|
24
|
|
6-month Follow-up
STARTED
|
119
|
95
|
|
6-month Follow-up
COMPLETED
|
91
|
78
|
|
6-month Follow-up
NOT COMPLETED
|
28
|
17
|
|
12-month Follow-up
STARTED
|
91
|
78
|
|
12-month Follow-up
COMPLETED
|
81
|
75
|
|
12-month Follow-up
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Parent and Child Classes (Prevention Group)
Parent and child groups focused on self-regulation of eating
|
Treatment as Usual (Control Group)
Treatment as usual, parents and children did not receive any treatment as the control group.
|
|---|---|---|
|
Group Allocation
Dropped out after randomization, did not attend any lessons, included in analyses as intent-to-treat
|
8
|
0
|
|
Post Data Collection
Dropped/withdrew from study
|
7
|
1
|
|
Post Data Collection
Lost to Follow-up
|
10
|
23
|
|
6-month Follow-up
Lost to Follow-up
|
28
|
17
|
|
12-month Follow-up
Lost to Follow-up
|
10
|
3
|
Baseline Characteristics
Data on child age are missing for 1 child in the prevention group and 2 children in the control group.
Baseline characteristics by cohort
| Measure |
Parent and Child Classes (Prevention Group)
n=136 Participants
Parent and child groups focused on self-regulation of eating
|
Treatment as Usual (Control Group)
n=119 Participants
Treatment as usual, parents and children did not receive any treatment as the control group.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=136 Participants
|
66 Participants
n=119 Participants
|
129 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
136 Participants
n=136 Participants
|
119 Participants
n=119 Participants
|
255 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=136 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=255 Participants
|
|
Age, Continuous
|
33.95 years
STANDARD_DEVIATION 7.12 • n=132 Participants • Data on parent age are missing for 4 parents in the prevention group and 3 parents in the control group.
|
32.53 years
STANDARD_DEVIATION 6.92 • n=116 Participants • Data on parent age are missing for 4 parents in the prevention group and 3 parents in the control group.
|
33.29 years
STANDARD_DEVIATION 7.05 • n=248 Participants • Data on parent age are missing for 4 parents in the prevention group and 3 parents in the control group.
|
|
Sex: Female, Male
Female
|
136 Participants
n=136 Participants
|
119 Participants
n=119 Participants
|
255 Participants
n=255 Participants
|
|
Region of Enrollment
United States
|
136 Parent/child dyad
n=136 Participants
|
119 Parent/child dyad
n=119 Participants
|
225 Parent/child dyad
n=255 Participants
|
|
Children's BMI Percentiles
Healthy weight (<85th percentile)
|
78 Participants
n=134 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
79 Participants
n=117 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
157 Participants
n=251 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
|
Children's BMI Percentiles
Overweight (85th to 95th percentile)
|
27 Participants
n=134 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
21 Participants
n=117 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
48 Participants
n=251 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
|
Children's BMI Percentiles
Obese (≥95th percentile)
|
29 Participants
n=134 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
17 Participants
n=117 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
46 Participants
n=251 Participants • Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group.
|
PRIMARY outcome
Timeframe: 12-month follow-upPopulation: Prevention group: 76 children assessed at 12-months. Treatment as usual control group: 71 children assessed at 12-months.
Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to \<85th percentile), overweight (≥85th to \<95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.
Outcome measures
| Measure |
Prevention Group
n=76 Participants
Focused on self-regulation of eating
|
Treatment as Usual Control Group
n=71 Participants
Treatment as usual control group did not receive any treatment
|
|---|---|---|
|
Children's BMI Percentiles
Healthy weight (<85th percentile)
|
49 Participants
|
41 Participants
|
|
Children's BMI Percentiles
Overweight (85th to 95th percentile)
|
15 Participants
|
18 Participants
|
|
Children's BMI Percentiles
Obese (≥95th percentile)
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12-month follow-upPopulation: Prevention group: 67 parents assessed at 12-months. Treatment as usual control group: 54 parents assessed at 12-months.
Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions.
Outcome measures
| Measure |
Prevention Group
n=67 Participants
Focused on self-regulation of eating
|
Treatment as Usual Control Group
n=54 Participants
Treatment as usual control group did not receive any treatment
|
|---|---|---|
|
Parental Feeding Behaviors
repeated presentation of new foods
|
3.5 score on a scale
Interval 3.3 to 3.7
|
3.2 score on a scale
Interval 3.02 to 3.44
|
|
Parental Feeding Behaviors
measured child portion sizes
|
3.1 score on a scale
Interval 2.82 to 3.32
|
2.5 score on a scale
Interval 2.23 to 2.74
|
|
Parental Feeding Behaviors
child involvement in food preparation
|
2.9 score on a scale
Interval 2.69 to 3.1
|
2.8 score on a scale
Interval 2.54 to 2.96
|
|
Parental Feeding Behaviors
feeding responsiveness
|
3.8 score on a scale
Interval 3.6 to 4.02
|
3.4 score on a scale
Interval 3.18 to 3.62
|
|
Parental Feeding Behaviors
knowledge of best feeding practices
|
4.1 score on a scale
Interval 4.0 to 4.21
|
3.9 score on a scale
Interval 3.81 to 4.02
|
|
Parental Feeding Behaviors
feeding misconceptions
|
3.0 score on a scale
Interval 2.85 to 3.11
|
3.2 score on a scale
Interval 3.1 to 4.02
|
|
Parental Feeding Behaviors
feeding efficacy
|
4.2 score on a scale
Interval 4.07 to 4.39
|
4.0 score on a scale
Interval 3.81 to 4.13
|
Adverse Events
Prevention Group
Treatment as Usual Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sheryl O. Hughes, Associate Professor
Baylor College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place