N/A
N=197
Lifestyle Education for Activity and Nutrition for a Leaner You
Body Weight Changes · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT00957008 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Waist Circumference — 105.87; 99.27; 102.32; 102.77 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group weight loss program (Behavioral); Group weight loss program plus use of the Senseware Armband (Other); Use of the senseware armband alone program (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Carolina
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waist Circumference |
107.10; 102.12; 102.99; 104.69 | — |
| PRIMARY Body Weight |
100.74; 96.83; 98.48; 101.23 | — |
| PRIMARY Body Weight |
100.74; 96.83; 98.48; 101.23 | — |
| PRIMARY Waist Circumference |
107.10; 102.12; 102.99; 104.69 | — |
| SECONDARY Blood Fasting Glucose |
-5.42; -12.59; -8.88; 1.99 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00957008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.