Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024843
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2001-09-28
Brief Title:
Family Based Interventions Preschool Children and Parent
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the efficacy of a 2-year family-based weight prevention program in a cohort of overweight preschool children and overweight parent pairs
Detailed Description:
BACKGROUND
The proposal targets a population of individuals of great public health importance who are of high risk for weight gain pre-school children of overweight parents Family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects and the choice to focus on both increased physical activity and healthier food choices in the context of the familys environment is appropriate The decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management A broad array of data is to be collected and strong justification is provided for the inclusion of each
The study is in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled Innovative Approaches to the Prevention of Obesity The resulting grant was later reassigned to the National Heart Lung and Blood Institute
DESIGN NARRATIVE
Approximately fifty childparent pairs were recruited and randomized evenly to one of two groups usual care versus an intervention focused on diet and activity strategies that included weekly group visits 24 weeks biweekly group visits for parents 12 weeks monthly group visits for parents 6 months and quarterly group visits 12 months Cognitive-behavioral therapy was used to guide interventions which focussed on empowering a parent as the primary medium by which lifestyle changes were made Major data collection at baseline twelve and 24 months included measures of weight food and activity records activity monitor recordings biopsychosocial profiles blood lipids glucose and insulin process measures parenting behavior and child behavior The primary study outcome measure was age- and gender-appropriate changes in BMI expressed as a binomial response Additional outcomes of particular interest were weight changes in the parent diet and physical activity levels parenting skills and biopsychosocial measures
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The proposal targets a population of individuals of great public health importance who are of high risk for weight gain pre-school children of overweight parents Family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects and the choice to focus on both increased physical activity and healthier food choices in the context of the familys environment is appropriate The decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management A broad array of data is to be collected and strong justification is provided for the inclusion of each
The study is in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled Innovative Approaches to the Prevention of Obesity The resulting grant was later reassigned to the National Heart Lung and Blood Institute
DESIGN NARRATIVE
Approximately fifty childparent pairs were recruited and randomized evenly to one of two groups usual care versus an intervention focused on diet and activity strategies that included weekly group visits 24 weeks biweekly group visits for parents 12 weeks monthly group visits for parents 6 months and quarterly group visits 12 months Cognitive-behavioral therapy was used to guide interventions which focussed on empowering a parent as the primary medium by which lifestyle changes were made Major data collection at baseline twelve and 24 months included measures of weight food and activity records activity monitor recordings biopsychosocial profiles blood lipids glucose and insulin process measures parenting behavior and child behavior The primary study outcome measure was age- and gender-appropriate changes in BMI expressed as a binomial response Additional outcomes of particular interest were weight changes in the parent diet and physical activity levels parenting skills and biopsychosocial measures
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL065133 | NIH | None | httpsreporternihgovquickSearchR01HL065133 |