Effect of wearable technology combined with a lifestyle intervention on long-term weight loss. The IDEA randomized clinical trial.
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Clinical Question
In patients wishing to lose weight, does the use of wearable technology in addition to behavioral weight loss interventions compared to behavioral weight loss interventions alone lead to increased weight loss?
Bottom Line
The use of wearable technology that monitors and provides feedback on physical activity does not offer an advantage over standard behavioral weight loss approaches.
Major Points
The clinical question focuses on whether the use of a wearable device to record and display health information will cause an increase in weight loss in patients involved in weight loss interventions compared to not wearing the device and still being involved in these same weight loss interventions. The weight loss interventions include monitoring and limiting caloric intake based on weight, timed physical activity, and regular contact with weight loss counseling groups.
The study design was a randomized clinical trial involving randomizing participants in one of two groups of standardized intervention (control) and enhanced intervention (variable). The outcome of the study resulted in significant findings that wearing a technological web-based device led to less weight loss than patients who did not use this wearable device.
The study focused on the average weight loss of patients which caused difficulty in assessing the results. The data received was also not measured with specific endpoints. The high dropout rate associated with the trial (>20%) diminished the accuracy of the study. Another poor aspect was that the wearable technology was from 2008, therefore it was outdated by the time of publishing the article and this wearable technology was only introduced to the intervention group 6 months into the trial. Lastly, bioanalysts conducting the trial weren’t blinded.
Guidelines
- National Institutes of Health’s Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults
- American College of Cardiology/American Heart Association Task Force on Practice Guidelines: Guideline for the management of overweight and obesity in adults
Design
Randomized clinical trial
- N = 470
- Wearable Technology (N = 237)
- Standard Treatment (N = 233)
- Setting: University of Pittsburgh
- Enrollment: October 2010 to October 2012
- Follow up: every 6 months for 2 years
- Analysis: per protocol
- Primary Outcome: Weight loss at 24 months
- Secondary Outcome: BMI, cardiorespiratory fitness, sedentary hours, total calories
Population
Inclusion Criteria
- Ages 18 to 35 years
- Body Mass Index of 25.0 to less than 40.0
- Access to cellular telephone that could receive text messages
- Computer with internet access
Exclusion Criteria
- Past or planned weight loss surgery
- Current use of systemic steroids or weight loss medication
- Current treatment for an eating disorder
- Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the prior 6 months
- Current treatment for malignancy other than non-melanoma skin cancer
- Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within study period
- Taking medication that would affect heart rate or blood pressure responses to exercise
- Self-reported weight loss of >5% of current body weight in the previous 3 months
- Current treatment for psychological issues or taking psychotropic medications within the previous 6 months
- Taking medication that could affect metabolism, appetite, or change body weight
- Current treatment for diabetes mellitus
- History of heart disease, angina, heart attack, stroke, or cancer
- Investigator discretion due to concerns related to study compliance
- Unable or unwilling to provide written consent
- Household member on the study staff
Baseline Characteristics
Demographics:
- Age 30.9 years
- 71.1% female
- 77.2% white
Vitals:
- Weight: 90.0 kg
- BMI: 31.2
Interventions
All groups were placed on a low calorie diet, received counseling sessions, and instructed to increase physical activity.
Enhanced intervention group received wearable devices with accompanied web interface to monitor physical activity and diet at 6 months
Standard treatment group received access to a website to self-monitor physical activity and diet at 6 months.
Outcomes
Presented as wearable technology vs. standard treatment
Primary Outcomes
- Weight loss at 24 months
- -3.5 kg vs. -5.9 kg (difference 2.4 kg; 95% CI, -3.7 to - 1.0 kg), p=0.002
Secondary Outcomes
All outcomes taken at 24 months
- Body mass index
- -1.1 kg/m 2 vs -1.8 kg/m 2 (difference 0.7, 95% CI, -1.9 to 0.4), p = ≥ 0.05
- Cardiorespiratory fitness
- 1.7. mL/kg/min vs. 2.0 mL/kg/min (difference 0.3 mL/kg/min, 95% CI -0.7 to 1.2) p = ≥ 0.05
- Sedentary hours
- -0.3 hours/day vs. 0.0 hours/day (difference -0.3, 95% CI, -0.8 to 0.2) p = ≥ 0.02
- Total Calories
- -543 kcal/day vs. -374.4 kcal/day (difference 169.3 kcal/d, 95% CI, 9.2 to 329.4) p = ≥ 0.05
Subgroup Analysis
No subgroup analysis performed.
Adverse Events
No adverse events were statistically significant.
Criticisms
- There is a high dropout rate associated with this trial (>20%)
- Wearable technology was only introduced to the intervention group after 6 months
- Data not measured with specific endpoints.
- Wearable technology from 2008; technology outdated by the time of publishing.
- Bioanalysts weren’t blinded.
Funding
Grant was received from the National Institutes of Health and the National Heart, Lung, and Blood Institute (NHLBI). Contribution of staff and graduate students at the Physical Activity and Weight Management Research Center and the Epidemiology Data Center at the University of Pittsburgh, who received salary support.