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Completed

NCT Number: NCT03940599

Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Investigating the impact of self-monitoring feedback for health behaviors

Completed

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Key information

Conditions

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

Age range

31 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Olaga Research Laboratory - Ministry of Health

Apia, Samoa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

step counter

Device

Fitbit

weight scale

Device

BodyTrace weight scale

step counter with screen covered

Device

Fitbit with screen covered

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 7, 2019
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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