Cell Phone Intervention in Young Adults
Condition: Obesity
Study type: Interventional

Summary: 
      Weight gain accelerates during early adulthood, and leads to the health consequences of
      obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll
      middle-aged adults. This study tests the hypothesis that a weight loss intervention that
      builds on prior research evidence but is enhanced with technological innovations will lead to
      weight loss in a diverse group of overweight and obese adults aged 18-35 years. The
      technology intervention, using cell phone applications, will be compared to an "advice only"
      control group and to a group receiving a more traditional personal coaching intervention.
    

Detailed description: 
      Trials in middle aged adults indicate that weight loss can be achieved and sustained with
      frequent contact over a long period of time, frequent self-monitoring, social support and
      motivational counseling. However, it is unclear whether this strategy would work in younger
      adults. Based on life stage, cultural context, environmental circumstances, and marketing
      pressures, behavioral intervention may need to be substantially modified to be effective in
      young adults. Even more adaptation will be required for intervention to be effective in young
      adults from racial/ethnic minority groups. The proposed intervention builds on prior evidence
      with innovations directed at increasing effectiveness in young adults.

      Using cell phones to deliver a weight control intervention in this age group has the
      potential to be engaging, enjoyable, practical, cost-effective, sustainable, and broadly
      disseminated. We propose a trial in which a highly innovative but more risky intervention
      based almost entirely on use of cell phone technology and a second more incremental
      innovation over traditional behavioral intervention are each compared to a usual care control
      group. We will recruit a diverse target population of overweight/obese, generally healthy
      young adults, comprising approximately 35% non-Latino Whites, 35% non-Latino Blacks, and 30%
      Latinos, to be randomized to: 1) Usual care control: Educational materials and information
      but no behavioral intervention; 2) Cell-phone intervention: similar education and knowledge
      as the control group, but thereafter a behavioral intervention will be delivered almost
      exclusively via cell phone, particularly using the self-monitoring and social networking
      features of this technology; 3) Personal contact with cell-phone enhancement: personal
      contact intervention enhanced by cell-phone for self-monitoring.

      The post-randomization intervention period will last 24 months. The primary outcome is change
      in weight 12 months post-randomization; an important secondary outcome is weight change at 24
      months.

      The formative phase will focus largely on technology/intervention development.

      To assess maintenance of weight loss, after completion of the primary outcome assessment (24
      months post-randomization), participants in the control group are followed observationally;
      those in the cell-phone and personal coaching interventions are re-randomized to either
      continue intervention or stop intervention with observational follow-up. All participants who
      agree to participate in this maintenance phase are followed for an additional 2-3 years with
      data collection every 6-12 months.
    

Intervention name(s): Behavioral weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): Behavioral lifestyle intervention for weight loss, compared to advice-only control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Young adults