Family Lifestyle Overweight Prevention Program
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

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.

        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.
    

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.
    

Intervention name(s): FLOW; SelfHelp
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric; Overweight; Obesity; Intervention; Prevention; Mexican American