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Lifestyle Education for Activity and Nutrition for a Leaner You (LEAN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957008
First Posted: August 11, 2009
Last Update Posted: July 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Carolina
August 7, 2009
August 11, 2009
February 21, 2011
March 23, 2011
July 27, 2015
February 2008
December 2009   (Final data collection date for primary outcome measure)
  • Body Weight and Waist Circumference [ Time Frame: Baseline, Month 4 and Month 9 ]
  • Body Weight [ Time Frame: nine month ]
    Body weight was assessed using a calibrated balance-beam scale.
Body Weight and Waist Circumference [ Time Frame: Baseline, Month 4 and Month 9 ]
Complete list of historical versions of study NCT00957008 on ClinicalTrials.gov Archive Site
Blood Fasting Glucose [ Time Frame: Month 9 ]
Weekly Energy Expenditure in Physical Activity; Weekly Caloric Intake; Percent of Participants Losing ≥5% of Baseline Body Weight; Stages of Motivational Readiness for Physical Activity and Diet Changes. [ Time Frame: Baseline, Month 4 and Month 9 ]
Not Provided
Not Provided
 
Lifestyle Education for Activity and Nutrition for a Leaner You
Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
  • Body Weight Changes
  • Overweight
  • Behavioral: Group weight loss program
    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.
    Other Name: Standard bahavior weight loss
  • Other: Group weight loss program plus use of the Senseware Armband
    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.
    Other Name: Standard behavioral weight loss plus Armband
  • Device: Use of the senseware armband alone program
    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 Name: Armband Alone
  • Experimental: A - GWL
    Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
    Intervention: Behavioral: Group weight loss program
  • Experimental: B - GWL+SWA
    Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
    Intervention: Other: Group weight loss program plus use of the Senseware Armband
  • Experimental: C - SWA Alone
    Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
    Intervention: Device: Use of the senseware armband alone program
  • No Intervention: D - Standard Care
    Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
Shuger SL, Barry VW, Sui X, McClain A, Hand GA, Wilcox S, Meriwether RA, Hardin JW, Blair SN. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial. Int J Behav Nutr Phys Act. 2011 May 18;8:41. doi: 10.1186/1479-5868-8-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years older men & women
  • Body mass index 25.0-39.9
  • Ability to provide informed consent

Exclusion Criteria:

  • Type I Diabetes
  • Type II diabetes taking insulin
  • Surgery or Hospitalization in last year (unless minor outpatient surgery)
  • Blood pressure >159/94
  • Cancer (other than non-melanoma skin cancer) in last 5 years
  • History of bariatric surgery
  • Current treatment with herbal, over-the-counter, or prescription weight loss drugs
  • Current treatment with ant-metabolite medications or other medications that affect weight
  • Current pregnancy or breastfeeding, or plans pregnancy in next 18 months gastrointestinal disorders including ulcerative colitis, Crohn's disease, malabsorption syndromes)
  • Chronic renal insufficiency
  • Chronic liver disease
  • History of anorexia nervosa, bulimia, laxative abuse
  • Current alcohol or substance abuse
  • Chronic heart failure, New York Heart Association Class III or IV
  • Uncontrolled arrythmia
  • Uncontrolled hyper- or hypothyroidism
  • Large weight loss of 20 or more kilograms in the past year
  • Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
  • Center for Epidemiologic Studies Depression Scale Score ≥ 16
  • Musculoskeletal problems interfering with exercise.
  • Autoimmune or collagen vascular diseases.
  • Immunodeficiency diseases or a positive Human immunodeficiency virus test
  • Unable to give informed consent
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00957008
HSA5211
Yes
Not Provided
Not Provided
University of South Carolina
University of South Carolina
Not Provided
Principal Investigator: Steven N Blair, PED University of South Carolina
University of South Carolina
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP