Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Obesity Clinical Trial

Official title:

Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940599
• Other study ID #: 2000021910
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating the impact of self-monitoring feedback for health behaviors

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 31 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• step counter
Fitbit
• weight scale
BodyTrace weight scale
• step counter with screen covered
Fitbit with screen covered

Locations

Country	Name	City	State
Samoa	Olaga Research Laboratory - Ministry of Health	Apia

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

Samoa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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).	1 week
Primary	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).	1 week
Primary	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.	2 weeks
Primary	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.	5 weeks
Primary	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.	5 weeks