Obese, Overweight
Conditions
Keywords
technology, healthy weight management, primary care setting
Brief summary
The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades. Obesity during the adolescent years is associated with many adverse health consequences, including T2DM, hyperlipidemia, and psychosocial problems. The first step toward effective obesity management and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the rapid expansion of cellular networks, and advancements in smartphone technologies, it is now possible to monitor PA and dietary intake and at the same time to transmit data digitally to their primary care providers (PCP). The proposed pilot study will include the collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese adolescents. The study will adapt and implement smartphone-based technologies and integrate these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid profile), at 3 months post intervention between the intervention and control groups. The smartphone app for the intervention group will allow the teens to graphically compare daily PA and dietary intake with the goal, participate in a reward program where they can collect virtual points for achieving the goal, and play interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to the feasibility study (Aim 2).
Detailed description
Using evidence to inform the design of clinical practice is a foundational principle of modern health care practice. In the present pilot study, using evidence from research on technology in clinical practice facilitated development of a hybrid intervention that combined lifestyle modification with routine clinical care. Chief among the benefits of this hybrid smartphone technology-based intervention (STB) was the potential to improve health outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention for overweight and obese adolescents and to (2) examine the intervention's feasibility for use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex, participation in the online educational program, and receipt of bi-weekly text message during the maintenance phase. A randomized control study design was utilized. Data regard to anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline, 3 month and 6 months after the baseline assessment.
Interventions
BEHAVIORALfitbit Ultra
Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.
BEHAVIORALPedometer
adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Primary care providers and outcome assessors were blinded to the group assignment.
Intervention model description
A randomized control study design with an active control group was used.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* between 13-18 years old * have a BMI at ≥ 85th percentile, based on CDC growth chart * own a smartphone; * have access to a computer with internet access * be able to read and speak English.
Exclusion criteria
* have acute or life-threatening disease * not be able to engage in activities of daily living
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | baseline and 6 months | Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | baseline and 6 months | Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used. |
Countries
United States
Participant flow
Recruitment details
The trained research assistant worked with primary care providers at two large community clinics whose patient populations were predominantly Chinese American in northern California. A study invitation letter was posted in the clinics. Pediatricians at the clinics were also given a study invitation letter to give to potential participants.
Pre-assignment details
An explanation of why potential participants were excluded from the study before assignment to groups was given them.
Participants by arm
| Arm | Count |
|---|---|
| Fitbit Ultra Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.
fitbit Ultra: Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet. | 23 |
| Pedometer After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
Pedometer: adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months. | 17 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Fitbit Ultra | Pedometer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 17 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.0 years STANDARD_DEVIATION 1.66 | 14.8 years STANDARD_DEVIATION 1.69 | 14.9 years STANDARD_DEVIATION 1.67 |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 8 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 17 |
| other Total, other adverse events | 0 / 23 | 0 / 17 |
| serious Total, serious adverse events | 0 / 23 | 0 / 17 |
Outcome results
Primary
Body Mass Index (BMI)
Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.
Time frame: baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitbit Ultra | Body Mass Index (BMI) | baseline data | 27.37 kg/m^2 | Standard Deviation 3.26 |
| Fitbit Ultra | Body Mass Index (BMI) | 6 months data | 26.93 kg/m^2 | Standard Deviation 3.42 |
| Pedometer | Body Mass Index (BMI) | baseline data | 28.35 kg/m^2 | Standard Deviation 4.36 |
| Pedometer | Body Mass Index (BMI) | 6 months data | 29.18 kg/m^2 | Standard Deviation 3.88 |
Comparison: This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.p-value: <0.001Mixed Models Analysis
Other Pre-specified
Diastolic Blood Pressure
Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.
Time frame: baseline and 6 months
Population: Adolescents who are overweight or obese were invited to participate in this study,
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitbit Ultra | Diastolic Blood Pressure | baseline | 72.74 mmhg | Standard Deviation 8.07 |
| Fitbit Ultra | Diastolic Blood Pressure | 6 month | 70.15 mmhg | Standard Deviation 7.53 |
| Pedometer | Diastolic Blood Pressure | baseline | 69.94 mmhg | Standard Deviation 11.25 |
| Pedometer | Diastolic Blood Pressure | 6 month | 72.14 mmhg | Standard Deviation 8.71 |
Comparison: We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.p-value: 0.001Mixed Models Analysis