Family Lifestyle Overweight Prevention Program (FLOW)
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| ClinicalTrials.gov Identifier: NCT00454610 |
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Recruitment Status :
Completed
First Posted : April 2, 2007
Last Update Posted : February 24, 2017
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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.
- At the end of 6 months, individuals randomly assigned to Intensive Intervention (II) (instructor/trainer led intervention) will lose more weight than individuals assigned to Self Help (SH) only.
- 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 (e.g., attendance, food diaries, exercise diaries), blood levels, changes in percent body fat, overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food frequency checklists.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight Obesity | Behavioral: FLOW Behavioral: SelfHelp | Phase 3 |
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 Help(SH) 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 - 97.5th % 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 parent/child 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 (i.e. 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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Family Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth |
| Study Start Date : | January 2005 |
| Study Completion Date : | March 2007 |
- standardized body mass index (zbmi)
- blood levels,
- changes in percent body fat,
- overall psychological functioning
- eating behaviors
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| Ages Eligible for Study: | 10 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Enrolled in the 6th or 7th grade at the target school.
- Parent consent and child assent to participate.
Exclusion Criteria:
- Taking medications for weight control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454610
| Principal Investigator: | John P Foreyt, Ph.D. | Baylor College of Medicine |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John P. Foreyt, Professor, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00454610 History of Changes |
| Other Study ID Numbers: |
H15671 |
| First Posted: | April 2, 2007 Key Record Dates |
| Last Update Posted: | February 24, 2017 |
| Last Verified: | February 2017 |
Keywords provided by John P. Foreyt, Baylor College of Medicine:
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Pediatric Overweight Obesity |
Intervention Prevention Mexican American |
Additional relevant MeSH terms:
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Overweight Body Weight Signs and Symptoms |