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Family Lifestyle Overweight Prevention Program (FLOW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454610
First Posted: April 2, 2007
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John P. Foreyt, Baylor College of Medicine
  Purpose

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) (instructor/trainer 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 (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 Intervention Phase
Overweight Obesity Behavioral: FLOW Behavioral: SelfHelp Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by John P. Foreyt, Baylor College of Medicine:

Primary Outcome Measures:
  • standardized body mass index (zbmi)

Secondary Outcome Measures:
  • blood levels,
  • changes in percent body fat,
  • overall psychological functioning
  • eating behaviors

Estimated Enrollment: 100
Study Start Date: January 2005
Estimated Study Completion Date: March 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: John P Foreyt, Ph.D. Baylor College of Medicine
  More Information

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 Submitted: March 30, 2007
First Posted: April 2, 2007
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by John P. Foreyt, Baylor College of Medicine:
Pediatric
Overweight
Obesity
Intervention
Prevention
Mexican American

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms