Lifestyle Education for Activity and Nutrition for a Leaner You

Completed · Not applicable

Conditions studied: Body Weight Changes, Overweight

In brief

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.

Key facts

Study ID: NCT00957008
Run by: University of South Carolina
People needed: 197
Starts: 2008-02-01
Expected to finish: 2009-12-01
Last updated by the study team: 2019-04-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of South Carolina Department of Exercise Science — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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