Lifestyle Education for Activity and Nutrition for a Leaner You
Condition: Body Weight Changes; Overweight
MeSH terms: Overweight; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      Although weight loss programs are effective in the short-term, maintaining weight loss is
      more challenging. Regularly tracking and logging physical activity (PA) and diet is related
      to greater improvements in PA and diet and to greater weight loss over time. Receiving
      continuous real-time feedback regarding calories burned and calories consumed could enhance
      weight loss maintenance. This study will examine whether a device that provides such
      feedback, called the SenseWear armband, enhances weight maintenance.

      200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups:
      (1) a standard behavior change weight loss group-based program (14 group sessions over a 4
      month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change
      weight loss group-based program (15 group session over a 4 month period followed by 6 phone
      calls over a 5 month period) combined with the armband, (3) the armband alone (training in
      the use of the armband and a follow up telephone call), or (4) a self-directed weight loss
      control group.

      Participants will be recruited through USC through listserv emails, flyers, and worksite
      advertisements. Interested individuals will take part in a telephone screen, an orientation,
      a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and
      a randomization visit. The intervention will then take place over a 9-month period with
      eligible participants. Participants will take part in follow-up assessments at month 4 and 9.
      Assessments at all three times will include questionnaires assessing diet, PA, psychosocial
      factors related to diet and PA, and quality of life related measures. They will also have
      their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure
      their blood pressure, waist circumference (size), skinfold, height, and weight.
    

Detailed description: 
      Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
      Research Summary Steven N. Blair, PED, Principal Investigator

      Primary Aim

      Dr. Blair and the investigative team will evaluate the contribution of the BodyMedia
      metabolic monitoring system to weight loss within the context of a standard behavioral weight
      loss program, and also as a stand alone system. The BodyMedia system consists of a metabolic
      monitor (armband) and computer software that analyzes energy expenditure, duration and level
      of physical activity, and other metabolic processes in free-living conditions. The proposed
      study will test the following hypotheses:

        1. The standard behavioral weight loss program (Standard), BodyMedia augmented program
           (Armband), and the Armband Alone will produce more weight loss and reduction in waist
           circumference over 4 months and maintain greater weight loss and reduction in waist
           circumference than does a usual care self-help program (Usual Care).

        2. The Armband program will produce weight loss and reduction in waist circumference
           comparable to the Standard program over 4 months.

        3. The Armband Alone program will produce weight loss and reduction in waist circumference
           comparable to the Standard program after 9 months.

        4. The Armband program will produce weight loss and reduction in waist circumference
           greater than the Standard program after 9 months.

      Primary Outcomes

        1. Body weight

        2. Waist circumference

      Secondary Outcomes

        1. Weekly energy expenditure in physical activity.

        2. Weekly caloric intake.

        3. Percent of participants losing ≥5% of baseline body weight.

        4. Stages of Motivational Readiness for physical activity and diet changes.

      Tertiary Outcomes

        1. Blood pressure.

        2. Fasting lipid profile.

        3. Fasting blood glucose.

        4. Fasting blood insulin

        5. Quality of life.

      Study Design

      The design will be a randomized controlled trial with four arms:

        1. Standard behavioral weight loss intervention program.

        2. Armband (standard behavioral weight loss intervention program augmented by using the
           BodyMedia armband and monitoring system to reinforce and support making changes in these
           behaviors).

        3. Armband Alone that includes a one-hour orientation at baseline on how to use the
           armband, with a one week follow-up telephone call to answer questions.

        4. Usual care (self-help with a diet and physical activity manual that provides guidance on
           changing these behaviors).

      Fifty participants will be assigned to each of the study arms. The Standard and Armband
      groups will participate in weekly group counseling sessions for four months. During months
      5-7 study staff will contact participants weekly via email or telephone to monitor their
      reports of dietary and physical activity logging, and to provide counseling support as
      necessary. During months 8 and 9, these contacts will be monthly. For the Armband Alone
      group, study staff will make monthly contact by telephone or email to answer questions and
      provide encouragement.

      Data collection for outcomes will occur at baseline, 4 months (no blood chemistry analyses
      will be performed at 4 months), and 9 months. Participants will be recruited into the study
      over several months, and all participants will have completed the follow-up (month 9) data
      collection by the end of the 18-month study period.
    

Intervention name(s): Group weight loss program; Group weight loss program plus use of the Senseware Armband; Use of the senseware armband alone program
Intervention type(s): Behavioral; Other; Device
Intervention description(s): Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.; Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning how to use the SenseWear Armband. They will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will receive a weight loss manual in addition to the group sessions and Armband.; Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
Other intervention name(s): Standard bahavior weight loss; Standard behavioral weight loss plus Armband; Armband Alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other