Lifestyle Education for Activity and Nutrition for a Leaner You
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/1/2018 |
| Start Date: | February 2008 |
| End Date: | December 2009 |
Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
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.
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.
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.
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.
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
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