Clinical trial NCT03940599: Investigating the Impact of Self-monitoring Feedback for Health Behaviors
Official title: Investigating the Impact of Self-monitoring Feedback for Health Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Investigating the impact of self-monitoring feedback for health behaviors

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.

Eligibility 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

Primary outcomes:
measure: Baseline Weight measure
timeFrame: baseline
measure: Weight measure - randomization
timeFrame: 1 week
measure: Psychological Indicators of Health questionnaire
timeFrame: 1 week
measure: Weight measure synching
timeFrame: 2 weeks
measure: Weight measure final
timeFrame: 5 weeks
measure: Psychosocial Indicators of Health final questionnaire
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Apia
country: Samoa
facility: Olaga Research Laboratory - Ministry of Health
Study officials:
affiliation: Yale School of Public Health
name: Erica Kocher
role: PRINCIPAL_INVESTIGATOR
References: