Family Lifestyle Overweight Prevention Program (FLOW)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
FLOW
SelfHelp
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Pediatric, Overweight, Obesity, Intervention, Prevention, Mexican American
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
standardized body mass index (zbmi)
Secondary Outcome Measures
blood levels,
changes in percent body fat,
overall psychological functioning
eating behaviors
Full Information
NCT ID
NCT00454610
First Posted
March 30, 2007
Last Updated
February 23, 2017
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00454610
Brief Title
Family Lifestyle Overweight Prevention Program
Acronym
FLOW
Official Title
Family Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Pediatric, Overweight, Obesity, Intervention, Prevention, Mexican American
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
FLOW
Intervention Type
Behavioral
Intervention Name(s)
SelfHelp
Primary Outcome Measure Information:
Title
standardized body mass index (zbmi)
Secondary Outcome Measure Information:
Title
blood levels,
Title
changes in percent body fat,
Title
overall psychological functioning
Title
eating behaviors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Foreyt, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17367735
Citation
Tyler C, Johnston CA, Fullerton G, Foreyt JP. Reduced quality of life in very overweight Mexican American adolescents. J Adolesc Health. 2007 Apr;40(4):366-8. doi: 10.1016/j.jadohealth.2006.10.015. Epub 2007 Feb 5.
Results Reference
background
PubMed Identifier
17999280
Citation
Johnston CA, Tyler C, Fullerton G, Poston WS, Haddock CK, McFarlin B, Reeves RS, Foreyt JP. Results of an intensive school-based weight loss program with overweight Mexican American children. Int J Pediatr Obes. 2007;2(3):144-52. doi: 10.1080/17477160701305864.
Results Reference
result
PubMed Identifier
18070745
Citation
Fullerton G, Tyler C, Johnston CA, Vincent JP, Harris GE, Foreyt JP. Quality of life in Mexican-American children following a weight management program. Obesity (Silver Spring). 2007 Nov;15(11):2553-6. doi: 10.1038/oby.2007.306.
Results Reference
result
PubMed Identifier
21515118
Citation
Johnston CA, Palcic JL, Tyler C, Stansberry S, Reeves RS, Foreyt JP. Increasing vegetable intake in Mexican-American youth: a randomized controlled trial. J Am Diet Assoc. 2011 May;111(5):716-20. doi: 10.1016/j.jada.2011.02.006.
Results Reference
derived
PubMed Identifier
19661957
Citation
Johnston CA, Tyler C, Fullerton G, McFarlin BK, Poston WS, Haddock CK, Reeves RS, Foreyt JP. Effects of a school-based weight maintenance program for Mexican-American children: results at 2 years. Obesity (Silver Spring). 2010 Mar;18(3):542-7. doi: 10.1038/oby.2009.241. Epub 2009 Aug 6. Erratum In: Obesity (Silver Spring). 2010 Mar;18(3):647. Fullerton, Ginny [added].
Results Reference
derived
PubMed Identifier
18055663
Citation
Johnston CA, Tyler C, McFarlin BK, Poston WS, Haddock CK, Reeves R, Foreyt JP. Weight loss in overweight Mexican American children: a randomized, controlled trial. Pediatrics. 2007 Dec;120(6):e1450-7. doi: 10.1542/peds.2006-3321.
Results Reference
derived
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Family Lifestyle Overweight Prevention Program
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