Clinical trial NCT00957008: Lifestyle Education for Activity and Nutrition for a Leaner You
Official title: Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Overweight
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Waist Circumference
timeFrame: Month 9
measure: Body Weight
timeFrame: nine month
measure: Body Weight
timeFrame: 4 month
measure: Waist Circumference
timeFrame: 4 month
Secondary outcomes:
measure: Blood Fasting Glucose
timeFrame: Month 9
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Department of Exercise Science
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Steven N Blair, PED
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.