Completed

FLOWFamily Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth

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What is being tested

Data Collection

Who is being recruted

Body Weight+1

+ Nutrition Disorders

+ Overnutrition

From 10 to 16 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleFamily Lifestyle Overweight Prevention Program: Evaluation of a Weight Management Program for Mexican American Youth 
Principal SponsorBaylor College of Medicine
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersOvernutritionOverweight

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers