Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Yale University

Status: Completed

Conditions: Obesity

Treatments: Device: step counter with screen covered; Device: step counter; Device: weight scale

Study type: Interventional

Funder types: Other

Identifiers

NCT03940599

2000021910

Details and patient eligibility

About

Investigating the impact of self-monitoring feedback for health behaviors

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 31 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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44 participants in 4 patient groups

Fitbit with visible screen

Experimental group

Description:

The first group will receive a FitBit with the screen visible, displaying their daily step count (the Step-Counter group).

Treatment:

Device: step counter

Scale group

Experimental group

Description:

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).

Treatment:

Device: step counter with screen covered

Device: weight scale

Step counter and scale

Experimental group

Description:

The third group will receive a BodyTrace scale and a FitBit with the screen visible (the Step-Counter and Scale group).

Treatment:

Device: step counter

Device: weight scale

Fitbit with screen covered

Sham Comparator group

Description:

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.

Treatment:

Device: step counter with screen covered