Investigating the Impact of Self-monitoring Feedback for Health Behaviors

NCT03940599 | Completed

• 1 other identifier: 2000021910
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the impact of self-monitoring feedback for health behaviors

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

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).

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).

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).

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.

Device: step counter with screen covered

Interventions

step counter DEVICE

Fitbit

Fitbit with visible screen; Step counter and scale

weight scale DEVICE

BodyTrace weight scale

Scale group; Step counter and scale

step counter with screen covered DEVICE

Fitbit with screen covered

Fitbit with screen covered; Scale group

Eligibility Criteria

• Age: 31 Years - 40 Years
• Gender Eligibility Details: The target population for this study are healthy, Samoan women between the ages of 31.5 and 40
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Samoan ethnicity (measured by their having four Samoan grandparents)
• 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.

You may not qualify if:

• If participant does not fit the requirements above

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Olaga Research Laboratory - Ministry of Health

Apia, Samoa

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Kocher

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 7, 2019
• Study Start: June 21, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

SA (1)