An interventional study of Behavioral and Nutrition Treatment and Education and Attention Control in Cystic Fibrosis and Pancreatic Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 5 sites in United States. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition intervention. This study will (a) determine the impact of the behavioral intervention on energy intake and weight gain; (b) examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment; and (c) explore the relation between physical activity and growth.
Evidence-based nutritional interventions that achieve and sustain optimal growth in young children with cystic fibrosis (CF) do not exist, despite an urgent need. Such an intervention could positively change the course of clinical lung disease and enhance survival for these children. The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition (attention control) intervention. All subjects will receive nutritional care consistent with the 2001 CF Consensus Conference guidelines for pediatric nutrition.
The specific aims are to:
From three CF Centers in Ohio, (Cincinnati Children's, Columbus Children's, Rainbow Babies and Children's Hospital in Cleveland), two referral centers in Ohio (Dayton Children's and Akron Children's), one CF Center in Michigan (University of Michigan-Ann Arbor), and one CF Center in Arizona (University of Arizona-Tucson), 100 preschoolers with CF and pancreatic insufficiency age 2 to 6 years will be randomized to one of the two conditions. The two groups will be stratified so that they are similar at the initiation of treatment on weight for age z score.
Other critical variables such as history of Pseudomonas aeruginosa infection and gender will be used as covariates in the statistical analysis plan. Outcome data (energy intake measured by 7-day diet record, weight, height) will be obtained at baseline, post-treatment (6 months), and after a 12-month follow-up (18 months post baseline).
Secondary measures will include body mass index, body composition measured by dual energy x-ray absorptiometry (DXA) and skinfolds, and growth velocity. Behavioral treatment will maximize adherence to a high energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. It involves 7 weekly sessions followed by 4 monthly sessions. The attention condition controls for time of contact and number of assessments conducted.
This study advances the investigation of early nutritional interventions for young children with CF and directly addresses the need for controlled, longitudinal assessment of behavioral intervention on growth. The long-range goal is to change the standard of nutritional care for young children with CF because behavioral intervention leads to optimal growth and ultimately improves lung health and survival.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 78 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The behavioral and nutrition treatment combines individualized nutritional counseling that targeted increasing energy and fat intake and parent training in behavioral child-management skills based on social learning theory to improve meal-time behaviors.
Behavioral: Behavioral and Nutrition Treatment
The education and attention control treatment provides education and served as a behavioral placebo in terms of controlling for attention and contact frequency provided. Families are provided with information including general nutrition, enzyme therapy, respiratory infection control, and typical child development anticipatory guidance and safety for preschool- aged children.
Behavioral: Education and Attention Control
This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
Also known as: control arm
Change in Energy Intake From Baseline to Post Treatment
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
Time frame: 6 months
Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment
This 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.
Time frame: 6 months
Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up
This 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.
Time frame: 18 months
| Milestone | Behavioral and Nutrition Treatment | Education and Attention Control Treatment |
|---|---|---|
| Started | 36 | 42 |
| Completed | 36 | 42 |
| Not completed | 0 | 0 |
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
| kilocalories per day | Behavioral and Nutrition Treatment | Education and Attention Control Treatment |
|---|---|---|
| Change in Energy Intake From Baseline to Post Treatment | 485 ± 355 | 58 ± 248 |
This 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.
| z-score | Behavioral and Nutrition Treatment | Education and Attention Control Treatment |
|---|---|---|
| Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment | 0.12 ± 0.40 | 0.06 ± 0.32 |
This 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.
| Z-score | Behavioral and Nutrition Treatment | Education and Attention Control Treatment |
|---|---|---|
| Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up | 0.09 ± 0.26 | -0.02 ± 0.32 |
Collected over Adverse events were assessed at each study visit up to the final 12 month follow up assessment (18 total months from baseline).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral and Nutrition Treatment | 0/36 (0%) | 0/36 (0%) | 34/36 (94.4%) |
| Education and Attention Control Treatment | 0/42 (0%) | 0/42 (0%) | 41/42 (97.6%) |
| Event | Behavioral and Nutrition Treatment | Education and Attention Control Treatment |
|---|---|---|
| DigestiveGastrointestinal disorders | 29/36 | 21/42 |
| RespiratoryRespiratory, thoracic and mediastinal disorders | 23/36 | 29/42 |
| ImmuneInfections and infestations | 12/36 | 19/42 |
| Head, ears, eyes, nose, throatInfections and infestations | 13/36 | 11/42 |
| Age, Continuous(years) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Mean | 3.8 ± 1.2 | 3.7 ± 1.3 | 3.8 ± 1.3 |
| Sex: Female, Male(Participants) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Female | 20 | 23 | 43 |
| Male | 16 | 19 | 35 |
| Race/Ethnicity, Customized(Participants) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Non-Hispanic | 35 | 40 | 75 |
| Race/Ethnicity, Customized(Participants) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Race-White | 35 | 42 | 77 |
| Energy Intake (kcal/day)(calories/day (kcal/day)) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Mean | 1462 ± 330 | 1461 ± 332 | 1462 ± 329 |
| Weight for Age Z score(z-score) | Behavioral and Nutrition Treatment | Education and Attention Control Treatment | Total |
|---|---|---|---|
| Mean | -0.36 ± 0.75 | -0.51 ± .85 | -0.44 ± 0.81 |
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Children's Hospital Medical Center, Cincinnati