Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of an enhanced technology-based system,
      that involves a wearable device to measure calories burned combined with a website, in
      comparison to previous versions of similar technology and a standard behavioral weight loss
      on body weight across 6 months in obese adults.
    

Detailed description: 
      The primary aim of this study is to compare changes in body weight between an in-person
      behavioral weight loss program, a technology-based system, and an enhanced version of a
      technology-based system during a 6 month behavioral weight loss intervention in obese adults.
      Additional aims will compare changes in body composition, physical activity, dietary intake,
      and the frequency of self-monitoring of weight loss behaviors between the 3 groups. A total
      of 84 sedentary, healthy obese adults (BMI: 35.0-45.0 kg/m2) between the ages of 21-55 will
      be recruited to participate. Assessments will be conducted at 0, 3, and 6 months and will
      include measurements of height, weight, body composition, blood pressure, physical activity,
      dietary intake, and eating behaviors. This is a randomized controlled trial in which
      participants will be randomized after the completion of assessments to one of three groups:
      standard behavioral weight loss (SBWL), BodyMedia® FIT System (FIT), and BodyMedia® FIT
      System with Bluetooth® enhancements (FIT-BT). Subjects in SBWL will participate in a
      behavioral weight loss intervention which includes weekly group sessions throughout the 6
      month program. FIT and FIT-BT will not attend weekly group sessions, but will have identical
      intervention materials mailed each week. FIT will receive the BodyMedia® FIT System, and
      FIT-BT will receive the BodyMedia® FIT System with Bluetooth® enhancements to use throughout
      the 6 month program. FIT and FIT-BT will receive a telephone intervention call 1x per month.
    

Intervention name(s): In-Person weight loss; FIT weight loss; FIT-BT weight loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback.; Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.; Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Exercise