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Lifestyle Education for Activity and Nutrition for a Leaner You

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00957008
Acronym
LEAN
Enrollment
197
Registered
2009-08-11
Start date
2008-02-29
Completion date
2009-12-31
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight Changes, Overweight

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.

Interventions

BEHAVIORALGroup 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.

OTHERGroup 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.

DEVICEUse 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.

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Waist CircumferenceMonth 9Waist circumference was measured at the level of the umbilicus with a plastic tape measure.
Body Weightnine monthBody weight was assessed using a calibrated balance-beam scale.

Secondary

MeasureTime frame
Blood Fasting GlucoseMonth 9

Countries

United States

Participant flow

Recruitment details

We conducted a total of 787 telephone screening interviews between February 2008 and February 2009 from the greater Columbia, South Carolina area. 197 men and women were eligible. Participants were recruited using a wide variety of techniques, including newspaper, mailers, community events, and worksite and other e-mail distributions.

Pre-assignment details

Exclusion criteria included significant weight loss (\>20 lbs) in the last 6 months, elevated blood pressure (160/95 mm Hg), ailments that limited their physical activity, or serious medical conditions or other issues (e.g. pregnancy or depression) contraindicating or confounding the weight loss intervention.

Participants by arm

ArmCount
Group-based Behavioral Weight Loss Education Group (GWL)
During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
49
Combined GWL and SWA Group (GWL+SWA)
These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
49
Armband Alone Group (SWA-alone)
The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
49
Standard Care (Control Group)
Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
50
Total197

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up3134
Overall StudyPhysician Decision1011
Overall StudyRelocated; Family conflict4113
Overall StudyWithdrawal by Subject13101216

Baseline characteristics

CharacteristicCombined GWL and SWA Group (GWL+SWA)Armband Alone Group (SWA-alone)Group-based Behavioral Weight Loss Education Group (GWL)Standard Care (Control Group)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants2 Participants0 Participants0 Participants3 Participants
Age, Categorical
Between 18 and 65 years
48 Participants47 Participants49 Participants50 Participants194 Participants
Age, Continuous45.7 years
STANDARD_DEVIATION 10.4
47.7 years
STANDARD_DEVIATION 11.6
46.8 years
STANDARD_DEVIATION 12.4
47.2 years
STANDARD_DEVIATION 8.9
46.9 years
STANDARD_DEVIATION 10.8
Region of Enrollment
United States
49 participants49 participants49 participants50 participants197 participants
Sex: Female, Male
Female
40 Participants40 Participants39 Participants42 Participants161 Participants
Sex: Female, Male
Male
9 Participants9 Participants10 Participants8 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 490 / 490 / 490 / 50
serious
Total, serious adverse events
0 / 490 / 490 / 490 / 50

Outcome results

Primary

Body Weight

Time frame: 4 month

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - GWLBody Weight100.74 kgStandard Error 2.99
B - GWL+SWABody Weight96.83 kgStandard Error 2.99
C - SWA AloneBody Weight98.48 kgStandard Error 2.97
D - Standard CareBody Weight101.23 kgStandard Error 3.03
Primary

Body Weight

Body weight was assessed using a calibrated balance-beam scale.

Time frame: nine month

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - GWLBody Weight99.98 KgStandard Error 3
B - GWL+SWABody Weight93.73 KgStandard Error 2.99
C - SWA AloneBody Weight97.60 KgStandard Error 2.99
D - Standard CareBody Weight101.32 KgStandard Error 3.05
Primary

Waist Circumference

Time frame: 4 month

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - GWLWaist Circumference107.10 cmStandard Error 2.23
B - GWL+SWAWaist Circumference102.12 cmStandard Error 2.21
C - SWA AloneWaist Circumference102.99 cmStandard Error 2.21
D - Standard CareWaist Circumference104.69 cmStandard Error 2.26
Primary

Waist Circumference

Waist circumference was measured at the level of the umbilicus with a plastic tape measure.

Time frame: Month 9

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
A - GWLWaist Circumference105.87 cmStandard Error 2.24
B - GWL+SWAWaist Circumference99.27 cmStandard Error 2.22
C - SWA AloneWaist Circumference102.32 cmStandard Error 2.23
D - Standard CareWaist Circumference102.77 cmStandard Error 2.28
Secondary

Blood Fasting Glucose

Time frame: Month 9

Population: Last observation carried forward

ArmMeasureValue (LEAST_SQUARES_MEAN)
A - GWLBlood Fasting Glucose-5.42 mg/dl
B - GWL+SWABlood Fasting Glucose-12.59 mg/dl
C - SWA AloneBlood Fasting Glucose-8.88 mg/dl
D - Standard CareBlood Fasting Glucose1.99 mg/dl

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026