ObesityNCT03940599
Investigating the Impact of Self-monitoring Feedback for Health Behaviors
A study testing step counter, weight scale and step counter with screen covered in people with Obesity, run by Yale University at 1 site in Samoa.
Trial summary
Investigating the impact of self-monitoring feedback for health behaviors Read more about this study
- Who is it for?
- Ages 31 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- step counter, weight scale and step counter with screen covered
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSamoa
- Study dates
- 21 Jun 2018to 31 Aug 2018
- 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 31 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Samoan ethnicity (measured by their having four Samoan grandparents)
- 31.5 - 40 years of age
- Physically inactive - defined using the World Health Organization (WHO) definition of inactivity and the WHO Global Physical Activity Questionnaire
- Motivated and ready to make behavior changes - defined using the Physical Activity Stages of Change framework (contemplation or preparation phase)18
- Not pregnant or planning to become pregnant during the 5-week study period - self-reported at baseline
- Weigh less than 180 kg - based on measured weight at baseline. This restriction is due to the maximum weight of the BodyTrace scales used in the intervention.
- No medical condition preventing physical activity or making participation inadvisable. These conditions will be measured based on self-report of doctor diagnoses and include: hypertension, heart attack, heart disease, stroke, uncontrolled Type 2 diabetes, non-skin cancer diagnosis, dialysis, or a diagnosed eating disorder. Participants will also be excluded if they have had significant (>10 kg) self-reported weight loss in the last 6 months.
Who cannot join
- If participant does not fit the requirements above
Trial locations and contacts
1 site in 1 country.
Samoa1 site
Olaga Research Laboratory - Ministry of Health
Apia
About this study
Investigating the impact of self-monitoring feedback for health behaviors
Read the detailed description
Obesity is highly prevalent in Samoa, where a 2010 study estimated that 64.6% of adult females were obese, according to Polynesian BMI cut offs (BMI ≥32.0 kg/m2).1,2 Interventions designed to increase physical activity or facilitate weight loss often include a self-monitoring component, but these intervention programs have not yet been tested in the Samoan setting. The goal of this project is to pilot test such an approach.
The specific aims of this study are:
- To investigate the acceptability and feasibility of self-monitoring of physical activity and weight through the introduction of step counting devices (FitBit Zips) and scales (BodyTrace).
- To measure any changes that occur in participants' health, health behaviors related to diet and physical activity, or conceptions of health (including self-efficacy and perceptions of weight) over the study period.
- Conditions
- Obesity
- Being tested
- step counter, weight scale, step counter with screen covered
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
step counterDevice
Fitbit
weight scaleDevice
BodyTrace weight scale
step counter with screen coveredDevice
Fitbit with screen covered
| Study group | Role | What they receive |
|---|---|---|
| Fitbit with visible screen | Experimental | The first group will receive a FitBit with the screen visible, displaying their daily step count (the Step-Counter group). Receives: Device: step counter |
| Scale group | Experimental | The second will receive a BodyTrace scale that will display and record their weight in kilograms and a FitBit with the screen covered as it was for the run-in period so their physical activity can be measured, but the only feedback they will receive is from the scale (the Scale group). Receives: Device: weight scale; Device: step counter with screen covered |
| Step counter and scale | Experimental | The third group will receive a BodyTrace scale and a FitBit with the screen visible (the Step-Counter and Scale group). Receives: Device: step counter; Device: weight scale |
| Fitbit with screen covered | Sham comparator | The remaining 5 participants will serve as normal controls and continue wearing the FitBit with the screen covered as it was during the run in period for the duration of follow up. Receives: Device: step counter with screen covered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Weight measure
This visit will take place on the same day as recruitment, after participants have completed the Village-Based Screening. Eligible participants will be flagged based on their responses to the screening questionnaire, at which point they will be informed of this additional project, complete an eligibility questionnaire, and, if interested in participating, give informed consent. At this baseline visit, they will receive a FitBit Zip with the screen covered so that they are not able to see any of the recorded information. The screen will be sealed such that the researcher will know if the participant has broken through to check the screen. Contact information will also be collected and a visit scheduled for one week later.
Measured: baseline
Weight measure - randomization
The participant will then complete a one week run in period to establish their baseline physical activity as measured by the FitBit. Participants will not be informed of their measured physical activity for this week and the screen will remain covered so that they are not receiving feedback from the device. After this period, the first home visit will take place. All participants will complete additional questionnaires at this time that will include information about their current health behaviors, their conceptions of their health (including their self-reported health status, self efficacy, health locus of control, and body image), and an estimate of their weight and perceived weight category (underweight, normal, overweight, or obese).
Measured: 1 week
Psychological Indicators of Health questionnaire
All participants will complete additional questionnaires at this time that will include information about their current health behaviors, their conceptions of their health (including their self-reported health status, self efficacy, health locus of control, and body image), and an estimate of their weight and perceived weight category (underweight, normal, overweight, or obese).
Measured: 1 week
Weight measure synching
The next visit will occur two weeks later, at the midpoint of the four week follow up period with the self-monitoring devices. This visit will not involve any further questionnaires and will occur for the purpose of syncing physical activity data from the FitBit, which only stores physical activity data for 23 total days.
Measured: 2 weeks
Weight measure final
The final visit will occur two weeks later, after the full four weeks of follow up with the devices. This visit occurs at week 5 of the study, including the one week run in period. At this point participants will repeat all of the questionnaires that they previously completed, as well as having their height and weight measured again. They will also complete added questions related to changes in their health behaviors over the past month of the follow up period. All participants will also complete a semi structured, qualitative interview to capture their experience of using the self-monitoring devices. These interviews are optional. The interview will include questions about what they did or did not like about the devices, how they felt about the feedback they were receiving, and how it may have influenced their thinking and behaviors. In addition, they will keep the device.
Measured: 5 weeks
Psychosocial Indicators of Health final questionnaire
This visit occurs at week 5 of the study, including the one week run in period. At this point participants will repeat all of the questionnaires that they previously completed, as well as having their height and weight measured again. They will also complete added questions related to changes in their health behaviors over the past month of the follow up period. All participants will also complete a semi structured, qualitative interview to capture their experience of using the self-monitoring devices. These interviews are optional. The interview will include questions about what they did or did not like about the devices, how they felt about the feedback they were receiving, and how it may have influenced their thinking and behaviors. In addition, they will keep the device.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start21 Jun 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Kocher, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940599
- Sponsor's protocol ID
- 2000021910
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Self-monitoring Feedback for Health Behaviors
- ClinicalTrials.gov ID
- NCT03940599
- Acronym / sponsor ID
- 2000021910
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 7 May 2019 (actual)
- 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.
Investigating the impact of self-monitoring feedback for health behaviors
Detailed description
Obesity is highly prevalent in Samoa, where a 2010 study estimated that 64.6% of adult females were obese, according to Polynesian BMI cut offs (BMI ≥32.0 kg/m2).1,2 Interventions designed to increase physical activity or facilitate weight loss often include a self-monitoring component, but these intervention programs have not yet been tested in the Samoan setting. The goal of this project is to pilot test such an approach.
The specific aims of this study are:
- To investigate the acceptability and feasibility of self-monitoring of physical activity and weight through the introduction of step counting devices (FitBit Zips) and scales (BodyTrace).
- To measure any changes that occur in participants' health, health behaviors related to diet and physical activity, or conceptions of health (including self-efficacy and perceptions of weight) over the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fitbit with visible screen | Experimental | Device: step counterThe first group will receive a FitBit with the screen visible, displaying their daily step count (the Step-Counter group). |
| Scale group | Experimental | Device: weight scale, Device: step counter with screen coveredThe second will receive a BodyTrace scale that will display and record their weight in kilograms and a FitBit with the screen covered as it was for the run-in period so their physical activity can be measured, but the only feedback they will receive is from the scale (the Scale group). |
| Step counter and scale | Experimental | Device: step counter, Device: weight scaleThe third group will receive a BodyTrace scale and a FitBit with the screen visible (the Step-Counter and Scale group). |
| Fitbit with screen covered | Sham comparator | Device: step counter with screen coveredThe remaining 5 participants will serve as normal controls and continue wearing the FitBit with the screen covered as it was during the run in period for the duration of follow up. |
Who may qualify
- Ages
- 31 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Samoan ethnicity (measured by their having four Samoan grandparents)
- 31.5 - 40 years of age
- Physically inactive - defined using the World Health Organization (WHO) definition of inactivity and the WHO Global Physical Activity Questionnaire
- Motivated and ready to make behavior changes - defined using the Physical Activity Stages of Change framework (contemplation or preparation phase)18
- Not pregnant or planning to become pregnant during the 5-week study period - self-reported at baseline
Key exclusion criteria (1 listed)
- If participant does not fit the requirements above
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 |
|---|---|---|
| step counterFitbit | Device | Fitbit with visible screen, Step counter and scale |
| weight scaleBodyTrace weight scale | Device | Scale group, Step counter and scale |
| step counter with screen coveredFitbit with screen covered | Device | Fitbit with screen covered, Scale group |
Primary outcome
Baseline Weight measure
Time frame: baseline
This visit will take place on the same day as recruitment, after participants have completed the Village-Based Screening. Eligible participants will be flagged based on their responses to the screening questionnaire, at which point they will be informed of this additional project, complete an eligibility questionnaire, and, if interested in participating, give informed consent. At this baseline visit, they will receive a FitBit Zip with the screen covered so that they are not able to see any of the recorded information. The screen will be sealed such that the researcher will know if the participant has broken through to check the screen. Contact information will also be collected and a visit scheduled for one week later.
Weight measure - randomization
Time frame: 1 week
The participant will then complete a one week run in period to establish their baseline physical activity as measured by the FitBit. Participants will not be informed of their measured physical activity for this week and the screen will remain covered so that they are not receiving feedback from the device. After this period, the first home visit will take place. All participants will complete additional questionnaires at this time that will include information about their current health behaviors, their conceptions of their health (including their self-reported health status, self efficacy, health locus of control, and body image), and an estimate of their weight and perceived weight category (underweight, normal, overweight, or obese).
Psychological Indicators of Health questionnaire
Time frame: 1 week
All participants will complete additional questionnaires at this time that will include information about their current health behaviors, their conceptions of their health (including their self-reported health status, self efficacy, health locus of control, and body image), and an estimate of their weight and perceived weight category (underweight, normal, overweight, or obese).
Weight measure synching
Time frame: 2 weeks
The next visit will occur two weeks later, at the midpoint of the four week follow up period with the self-monitoring devices. This visit will not involve any further questionnaires and will occur for the purpose of syncing physical activity data from the FitBit, which only stores physical activity data for 23 total days.
Weight measure final
Time frame: 5 weeks
The final visit will occur two weeks later, after the full four weeks of follow up with the devices. This visit occurs at week 5 of the study, including the one week run in period. At this point participants will repeat all of the questionnaires that they previously completed, as well as having their height and weight measured again. They will also complete added questions related to changes in their health behaviors over the past month of the follow up period. All participants will also complete a semi structured, qualitative interview to capture their experience of using the self-monitoring devices. These interviews are optional. The interview will include questions about what they did or did not like about the devices, how they felt about the feedback they were receiving, and how it may have influenced their thinking and behaviors. In addition, they will keep the device.
Psychosocial Indicators of Health final questionnaire
Time frame: 5 weeks
This visit occurs at week 5 of the study, including the one week run in period. At this point participants will repeat all of the questionnaires that they previously completed, as well as having their height and weight measured again. They will also complete added questions related to changes in their health behaviors over the past month of the follow up period. All participants will also complete a semi structured, qualitative interview to capture their experience of using the self-monitoring devices. These interviews are optional. The interview will include questions about what they did or did not like about the devices, how they felt about the feedback they were receiving, and how it may have influenced their thinking and behaviors. In addition, they will keep the device.
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 Jul 2021.
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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.
Erica Kocher principal investigator
Yale School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing step counter, weight scale and step counter with screen covered in people with Obesity, run by Yale University at 1 site in Samoa.
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 1 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 Jul 2021. 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 Samoa. 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. Some participants in this study may receive a placebo. 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?
Baseline Weight measure (time frame: baseline). The study lists 6 primary outcomes in all. 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 Jul 2021.