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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Clinicaltrials.gov identifier NCT03940599

Recruitment Status Active, not recruiting

First Posted May 7, 2019

Last update posted July 17, 2019

Study Description

Brief summary:

Investigating the impact of self-monitoring feedback for health behaviors

  • Condition or Disease:Obesity
  • Intervention/Treatment: Device: step counter
    Device: weight scale
    Device: step counter with screen covered
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2018
  • Estimated Primary Completion Date: October 2018
  • Actual Study Completion Date: December 2019
Arms and interventions
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: 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
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
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 31 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • 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

Contacts and Locations
Contacts
Locations

Samoa
Olaga Research Laboratory - Ministry of Health
Apia

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Erica Kocher Yale School of Public Health

More Information
  • Responsible Party: Yale University
  • ClinicalTrials.gov Identifier: NCT03940599 History of Changes
  • Other Study ID Numbers: 2000021910
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: July 17, 2019
  • Last Verified: July 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No