ObesityNCT02742662
Smart Technology for Weight Loss and Metabolic Health
A study testing Wearable technology, smartscale, Smartphone applications and Standard Weight Management Visits in people with Obesity and Overweight, run by Temple University at 1 site in United States.
Trial summary
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight, Prediabetes
- What is being tested?
- Wearable technology, smartscale, Smartphone applications and Standard Weight Management Visits
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese BMI 25-42 kg/m2
- Employed in sedentary occupations
- Own a personal smartphone with unlimited data plan or >4 GigaByte data
- Proficient with use of smartphone applications and technology with current daily usage
- Ability to engage in moderate intensity exercise
- Weight stability for the last 2 months
- Participants must be willing to comply with all study-related procedures
Who cannot join
- Current or planned pregnancy
- Cardiovascular, pulmonary, renal disease, joint disease
- Uncontrolled thyroid disease
- History of eating disorders, psychiatric disease
- History of substance abuse or dependence in the last 1 year
- Diabetes
Show all 13Show fewer
- Shift work
- Previous weight loss surgery
- Use of weight loss drugs/diet/program in the last 6 weeks
- Inability to increase walking as a form of exercise and to engage in moderate intensity exercise
- Other conditions or medications that affect body weight/appetite/metabolism
- Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
- Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Technology for Weight Loss and Metabolic Health- A Randomized Controlled Trial
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.
- Conditions
- Obesity, Overweight, Prediabetes, Weight Loss, Lifestyle
- Being tested
- Wearable technology, smartscale, Smartphone applications, Standard Weight Management Visits
- Keywords
- Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable technology, smartscaleDevice
Smartphone applicationsBehavioural
Standard Weight Management VisitsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smart Technology Group | Experimental | The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits. Receives: Device: Wearable technology, smartscale; Behavioral: Smartphone applications; Behavioral: Standard Weight Management Visits |
| Standard Weight Management Group | Other | The Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline. Receives: Behavioral: Standard Weight Management Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight in kg
Measured: 6 months
Secondary outcomes (13)
Change from baseline blood pressure
Measured: 6 months
Change from baseline waist circumference
Measured: 6 months
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)
Measured: 6 months
Change from baseline hemoglobin A1c
Measured: 6 months
Change from baseline plasma triglycerides
Measured: 6 months
Change from baseline body weight in kg
Measured: 3 months
Change from baseline body weight in kg
Measured: 12 months
Change from baseline blood pressure
Measured: 12 months
Change from baseline waist circumference
Measured: 12 months
Change in Quality of Life
SF36 Questionnaire in wait-listed control group after the intervention
Measured: 6 months after receiving the intervention
Change in insulin resistance by homeostasis model assessment (HOMA-IR)
Wait-listed control group
Measured: 12 months compared to baseline and 6 months after receiving the intervention
Change in hemoglobin A1c
Wait-listed control group
Measured: 12 months compared to baseline and 6 months after receiving the intervention and from baseline
Change in plasma triglycerides
Wait-listed control group
Measured: 12 months compared to baseline and 6 months after receiving the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Treatment Foundation
- Responsible party
- Sponsor
- Investigators
- Cherie Vaz, MD Dipl ABOM, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742662
- Sponsor's protocol ID
- 23217
- Status last verified
- Feb 2018
- First submitted
- 7 Apr 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Technology for Weight Loss and Metabolic Health- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02742662
- Acronym / sponsor ID
- 23217
- Conditions
- Obesity, Overweight, Prediabetes, Weight Loss, Lifestyle
- Keywords
- Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- The Obesity Treatment Foundation
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Technology Group | Experimental | Device: Wearable technology, smartscale, Behavioral: Smartphone applications, Behavioral: Standard Weight Management VisitsThe Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits. |
| Standard Weight Management Group | Other | Behavioral: Standard Weight Management VisitsThe Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Overweight or obese BMI 25-42 kg/m2
- Employed in sedentary occupations
- Own a personal smartphone with unlimited data plan or >4 GigaByte data
- Proficient with use of smartphone applications and technology with current daily usage
- Ability to engage in moderate intensity exercise
Key exclusion criteria (13 listed)
- Current or planned pregnancy
- Cardiovascular, pulmonary, renal disease, joint disease
- Uncontrolled thyroid disease
- History of eating disorders, psychiatric disease
- History of substance abuse or dependence in the last 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable technology, smartscale | Device | Smart Technology Group |
| Smartphone applications | Behavioural | Smart Technology Group |
| Standard Weight Management Visits | Behavioural | Smart Technology Group, Standard Weight Management Group |
Primary outcome
Change in body weight in kg
Time frame: 6 months
13 secondary outcomes
Change from baseline blood pressure
Time frame: 6 months
Change from baseline waist circumference
Time frame: 6 months
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)
Time frame: 6 months
Change from baseline hemoglobin A1c
Time frame: 6 months
Change from baseline plasma triglycerides
Time frame: 6 months
Change from baseline body weight in kg
Time frame: 3 months
Change from baseline body weight in kg
Time frame: 12 months
Change from baseline blood pressure
Time frame: 12 months
Change from baseline waist circumference
Time frame: 12 months
Change in Quality of Life
Time frame: 6 months after receiving the intervention
Change in insulin resistance by homeostasis model assessment (HOMA-IR)
Time frame: 12 months compared to baseline and 6 months after receiving the intervention
Change in hemoglobin A1c
Time frame: 12 months compared to baseline and 6 months after receiving the intervention and from baseline
Change in plasma triglycerides
Time frame: 12 months compared to baseline and 6 months after receiving the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherie Vaz, MD Dipl ABOM principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable technology, smartscale, Smartphone applications and Standard Weight Management Visits in people with Obesity and Overweight, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight in kg (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.