Trial Outcomes & Findings for Behavioral & Nutritional Treatment to Help CF Preschoolers Grow (NCT NCT00241969)
NCT ID: NCT00241969
Last Updated: 2018-05-22
Results Overview
This primary outcome measure compared change in energy intake from baseline to post treatment between the behavioral and nutrition treatment and the education and attention control treatment. Energy intake was assessed using a 7-day diet diary recorded by parents and analyzed using Nutrition Data System for Research Software, Version 2011. Data were examined as average kilocalories per day over the 7 day period at baseline and post treatment. The mean (SD) change in energy intake was compared between baseline to post treatment was
COMPLETED
NA
78 participants
6 months
2018-05-22
Participant Flow
Participant milestones
| Measure |
Behavioral and Nutrition Treatment
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
42
|
|
Overall Study
COMPLETED
|
36
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
Baseline characteristics by cohort
| Measure |
Behavioral and Nutrition Treatment
n=36 Participants
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
n=42 Participants
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.8 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
3.7 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.8 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race-White
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Energy Intake (kcal/day)
|
1462 calories/day (kcal/day)
STANDARD_DEVIATION 330 • n=5 Participants
|
1461 calories/day (kcal/day)
STANDARD_DEVIATION 332 • n=7 Participants
|
1462 calories/day (kcal/day)
STANDARD_DEVIATION 329 • n=5 Participants
|
|
Weight for Age Z score
|
-0.36 z-score
STANDARD_DEVIATION 0.75 • n=5 Participants
|
-0.51 z-score
STANDARD_DEVIATION .85 • n=7 Participants
|
-0.44 z-score
STANDARD_DEVIATION 0.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis primary outcome measure compared change in energy intake from baseline to post treatment between the behavioral and nutrition treatment and the education and attention control treatment. Energy intake was assessed using a 7-day diet diary recorded by parents and analyzed using Nutrition Data System for Research Software, Version 2011. Data were examined as average kilocalories per day over the 7 day period at baseline and post treatment. The mean (SD) change in energy intake was compared between baseline to post treatment was
Outcome measures
| Measure |
Behavioral and Nutrition Treatment
n=36 Participants
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
n=42 Participants
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
|---|---|---|
|
Change in Energy Intake From Baseline to Post Treatment
|
485 kilocalories per day
Standard Deviation 355
|
58 kilocalories per day
Standard Deviation 248
|
PRIMARY outcome
Timeframe: 6 monthsThis outcome measure examines the change in weight for age Z-score (WAZ) from baseline to post treatment. Weight was measured in kilograms, measured to the nearest 100 grams, obtained using a digital scale by trained study staff. All measurements were obtained in triplicate and then the mean used for analyses. Weight for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean.
Outcome measures
| Measure |
Behavioral and Nutrition Treatment
n=36 Participants
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
n=42 Participants
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
|---|---|---|
|
Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment
|
0.12 z-score
Standard Deviation 0.40
|
0.06 z-score
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: 18 monthsThis outcome measure examines the change in height for age Z-score (HAZ) from baseline to follow up. Height was measured standing unless the child was unwilling to stand, then a supine measurement was obtained. All measurements were obtained in triplicate and then the mean used for analyses. Height for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean.
Outcome measures
| Measure |
Behavioral and Nutrition Treatment
n=36 Participants
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
n=42 Participants
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
|---|---|---|
|
Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up
|
0.09 Z-score
Standard Deviation 0.26
|
-0.02 Z-score
Standard Deviation 0.32
|
Adverse Events
Behavioral and Nutrition Treatment
Education and Attention Control Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral and Nutrition Treatment
n=36 participants at risk
Behavioral and Nutrition Treatment
Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.
|
Education and Attention Control Treatment
n=42 participants at risk
Education and Attention Control Treatment
Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.
|
|---|---|---|
|
Gastrointestinal disorders
Digestive
|
80.6%
29/36 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
50.0%
21/42 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
|
Infections and infestations
Immune
|
33.3%
12/36 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
45.2%
19/42 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
63.9%
23/36 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
69.0%
29/42 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
|
Infections and infestations
Head, ears, eyes, nose, throat
|
36.1%
13/36 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
26.2%
11/42 • Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).
|
Additional Information
Scott Powers, PhD
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place