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Investigating the Impact of Self-monitoring Feedback for Health Behaviors

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ClinicalTrials.gov Identifier: NCT03940599
Recruitment Status : Active, not recruiting
First Posted : May 7, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
Investigating the impact of self-monitoring feedback for health behaviors

Condition or disease Intervention/treatment Phase
Obesity Device: step counter Device: weight scale Device: step counter with screen covered Not Applicable

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:

  1. 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).
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigating the Impact of Self-monitoring Feedback for Health Behaviors
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : October 4, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Fitbit with visible screen
The first group will receive a FitBit with the screen visible, displaying their daily step count (the Step-Counter group).
Device: step counter
Fitbit

Experimental: Scale group
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).
Device: weight scale
BodyTrace weight scale

Device: step counter with screen covered
Fitbit with screen covered

Experimental: Step counter and scale
The third group will receive a BodyTrace scale and a FitBit with the screen visible (the Step-Counter and Scale group).
Device: step counter
Fitbit

Device: weight scale
BodyTrace weight scale

Sham Comparator: Fitbit with screen covered
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.
Device: step counter with screen covered
Fitbit with screen covered




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The target population for this study are healthy, Samoan women between the ages of 31.5 and 40
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • If participant does not fit the requirements above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940599


Locations
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Samoa
Olaga Research Laboratory - Ministry of Health
Apia, Samoa
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Erica Kocher Yale School of Public Health
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03940599    
Other Study ID Numbers: 2000021910
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No