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The purpose of this study is to examine the effect of an enhanced technology-based system, that involves a wearable device to measure calories burned combined with a website, in comparison to previous versions of similar technology and a standard behavioral weight loss on body weight across 6 months in obese adults.
The primary aim of this study is to compare changes in body weight between an in-person behavioral weight loss program, a technology-based system, and an enhanced version of a technology-based system during a 6 month behavioral weight loss intervention in obese adults. Additional aims will compare changes in body composition, physical activity, dietary intake, and the frequency of self-monitoring of weight loss behaviors between the 3 groups. A total of 84 sedentary, healthy obese adults (BMI: 35.0-45.0 kg/m2) between the ages of 21-55 will be recruited to participate. Assessments will be conducted at 0, 3, and 6 months and will include measurements of height, weight, body composition, blood pressure, physical activity, dietary intake, and eating behaviors. This is a randomized controlled trial in which participants will be randomized after the completion of assessments to one of three groups: standard behavioral weight loss (SBWL), BodyMedia® FIT System (FIT), and BodyMedia® FIT System with Bluetooth® enhancements (FIT-BT). Subjects in SBWL will participate in a behavioral weight loss intervention which includes weekly group sessions throughout the 6 month program. FIT and FIT-BT will not attend weekly group sessions, but will have identical intervention materials mailed each week. FIT will receive the BodyMedia® FIT System, and FIT-BT will receive the BodyMedia® FIT System with Bluetooth® enhancements to use throughout the 6 month program. FIT and FIT-BT will receive a telephone intervention call 1x per month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person weight loss | Experimental | Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback. |
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| FIT weight loss | Experimental | Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
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| FIT-BT weight loss | Experimental | Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person weight loss | Behavioral | Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Baseline, 3 months, and 6 months | |
| Change in moderate-to-vigorous intensity physical activity | Baseline, 3 months, and 6 months | |
| Change in dietary intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M Jakicic, PhD | University of Pittsburgh | Principal Investigator |
| Renee J Rogers, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| FIT weight loss | Behavioral | Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
|
| FIT-BT weight loss | Behavioral | Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
|
| Baseline, 3 months, and 6 months |
| Completion of self-monitoring of eating behavior | The frequency that participants engaged in the self-monitoring of eating behavior as measured by either completion of an eating diary or the use of the BodyMedia Fit system software. | Baseline to 6 months |
| Frequency of self-monitoring of physical activity behavior | The frequency that participants engaged in the self-monitoring of physical activity as measured by either completion of an exercise diary or the use of the BodyMedia Fit system. | Baseline to 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |