Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454610
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2007-03-30
Brief Title:
Family Lifestyle Overweight Prevention Program
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Family Lifestyle Overweight Prevention Program Evaluation of a Weight Management Program for Mexican American Youth
Status:
COMPLETED
Status Verified Date:
2017-02
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:
FLOW
Brief Summary:
The purpose of the study was to design a weight management program for Mexican American youth and to determine the effectiveness of the program for weight management compared to a self help program
1 At the end of 6 months individuals randomly assigned to Intensive Intervention II instructortrainer led intervention will lose more weight than individuals assigned to Self Help SH only
2 At the end of 1 year individuals randomly assigned to II will maintain their weight losses better than individuals assigned to SH
Secondary hypotheses will include examination of main effects and interactions at the end of 6 months with the following secondary dependent measures treatment adherence eg attendance food diaries exercise diaries blood levels changes in percent body fat overall psychological functioning PEDS-QL 40 and eating behaviors as assessed by food frequency checklists
1 At the end of 6 months individuals randomly assigned to Intensive Intervention II instructortrainer led intervention will lose more weight than individuals assigned to Self Help SH only
2 At the end of 1 year individuals randomly assigned to II will maintain their weight losses better than individuals assigned to SH
Secondary hypotheses will include examination of main effects and interactions at the end of 6 months with the following secondary dependent measures treatment adherence eg attendance food diaries exercise diaries blood levels changes in percent body fat overall psychological functioning PEDS-QL 40 and eating behaviors as assessed by food frequency checklists
Detailed Description:
The overall objective of this study is to compare the effectiveness of a behavioral family-based weight management program and a self-help only group for the prevention of obesity in adolescents The treatments are Self HelpSH Instructions to follow a 12-week self help manual for healthy eating and increased physical activity Intensive Intervention II 12 Weeks of daily and 7 Monthly sessions consisting of nutrition instruction physical activity training and behavior modification instruction One hundred BMI-for-age 85th - 975th or parent BMI 25 adolescent males and females will be recruited into the study and randomly assigned to SH Instructions to follow the self help manual for healthy eating and increased physical activity II 12 Weeks daily and 7 Monthly sessions consisting of nutrition instruction physical activity training and behavior modification instruction for one year Participants will receive final measurements at the end of year 1 and intermediate evaluations at month 6 Given that the interventions decline in intensity and frequency after 3 months the 1 year assessments will help evaluate which treatment was most effective in maintaining weight losses with minimal contact
SH will consist of participants being instructed to follow a 12-week parentchild based self help book for weight loss but they will not receive any active intervention The manual TRIM Kids Sothern von Almen Schumacher 2001 that the families will follow is a treatment program which uses a family-based behavioral intervention that focuses on diet and exercise with instructions and guidelines designed to assist the family in maintaining weight losses II will consist of 12 Weeks of daily and 7 Monthly sessions consisting of nutrition instruction physical activity training and behavior modification instruction over the 1-year period Body mass index BMI blood analyses ie cholesterol triglycerides insulin glucose C-reactive protein mono-unsaturated fatty acids and inflammatory cytokines analysis of eating and exercise behavior and eating and exercise self-efficacy measures will be taken throughout the study The focus of this study is to evaluate the effectiveness of an active behaviorally designed intervention for the prevention of adult obesity
SH will consist of participants being instructed to follow a 12-week parentchild based self help book for weight loss but they will not receive any active intervention The manual TRIM Kids Sothern von Almen Schumacher 2001 that the families will follow is a treatment program which uses a family-based behavioral intervention that focuses on diet and exercise with instructions and guidelines designed to assist the family in maintaining weight losses II will consist of 12 Weeks of daily and 7 Monthly sessions consisting of nutrition instruction physical activity training and behavior modification instruction over the 1-year period Body mass index BMI blood analyses ie cholesterol triglycerides insulin glucose C-reactive protein mono-unsaturated fatty acids and inflammatory cytokines analysis of eating and exercise behavior and eating and exercise self-efficacy measures will be taken throughout the study The focus of this study is to evaluate the effectiveness of an active behaviorally designed intervention for the prevention of adult obesity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None