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Family Lifestyle Overweight Prevention Program (FLOW)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
FLOW
SelfHelp
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Pediatric, Overweight, Obesity, Intervention, Prevention, Mexican American

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 30, 2007
    Last Updated
    February 23, 2017
    Sponsor
    Baylor College of Medicine
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    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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