Lifestyle Education for Activity and Nutrition for a Leaner You

Overweight Clinical Trial

— LEAN  

Official title:

Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957008
• Other study ID #: Pro00005091
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Overweight

Intervention

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:
• 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.

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.

Locations

Country	Name	City	State
United States	University of South Carolina Department of Exercise Science	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist Circumference	Waist circumference was measured at the level of the umbilicus with a plastic tape measure.	Month 9
Primary	Body Weight	Body weight was assessed using a calibrated balance-beam scale.	nine month
Primary	Body Weight		4 month
Primary	Waist Circumference		4 month
Secondary	Blood Fasting Glucose		Month 9