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

This study has been completed.
Sponsor:
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT00957008
First received: August 7, 2009
Last updated: March 22, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Body Weight Changes
Overweight
Behavioral: Group weight loss program
Other: Group weight loss program plus use of the Senseware Armband
Device: Use of the senseware armband alone program
Behavioral: Self-directed weight loss program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Body Weight and Waist Circumference [ Time Frame: Baseline, Month 4 and Month 9 ] [ Designated as safety issue: No ]
  • Body Weight [ Time Frame: nine month ] [ Designated as safety issue: No ]
    Body weight was assessed using a calibrated balance-beam scale.


Secondary Outcome Measures:
  • Blood Fasting Glucose [ Time Frame: Month 9 ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Group weight loss program
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
Experimental: B
Group weight loss plus use of the SenseWear Armband
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
Experimental: C
SenseWear 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
No Intervention: D
Self-directed weight loss program
Behavioral: Self-directed weight loss program
Participants will be asked to attend a thirty-minute health education session at the University of South Carolina's Public Health Research Center (PHRC). They will also receive a weight loss manual.
Other Name: Control group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957008

Locations
United States, South Carolina
University of South Carolina Department of Exercise Science
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Steven N Blair, PED University of South Carolina
  More Information

No publications provided by University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven N. Blair/Principal investigator, University of South Carolina
ClinicalTrials.gov Identifier: NCT00957008     History of Changes
Other Study ID Numbers: HSA5211, FWA 00000404, 00000240
Study First Received: August 7, 2009
Results First Received: February 21, 2011
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014